Podcasts about stelara

A new epinephrine nasal spray dosage has been approved for pediatrics; FDA agree to review Semaglutide for weight management; A wearable defibrillator is cleared to prevent sudden cardiac arrest; a low dose formulation of chlorthalidone is approved to treat hypertension; and Selarsdi is now interchangeable with Stelara.

Johnson & Johnson’s Stelara, Regeneron’s Eylea and Amgen’s Prolia are just some of the drugs facing off against new biosimilars or generics in 2025, as featured in the latest edition of Fierce Pharma’s annual special report documenting the 10 biggest losses of U.S. exclusivity expected throughout the year. In this week’s episode of The Top Line, we dig into the report, which details the stories behind 10 key medicines that are set to face off against new generic or biosimilar competitors this year as their patents expire. Fierce’s Eric Sagonowsky and Angus Liu recap the report, sharing their perspectives on several of the drugs and discussing the industry effects of 2025’s sizable patent cliff. To learn more about the topics in this episode: The top 10 drugs losing US exclusivity in 2025 After patent settlement, Amgen scores FDA nod for its biosimilar version of J&J's Stelara Amgen grabs FDA thumbs-up for Soliris biosim, eyes 2025 launch Novartis wins 11th-hour bid to block generic version of blockbuster heart med Entresto Amgen settles Prolia patent suit with Celltrion, teeing up potential biosimilar launch in June See omnystudio.com/listener for privacy information.

Generics Bulletin editors Dave Wallace and Dean Rudge discuss the latest updates on Stelara (ustekinumab) biosimilars in the US, including recent launches, pricing strategies, and parallels with the biosimilar Humira (adalimumab) experience.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. J&J is currently involved in a legal battle with Samsung Bioepis, alleging unlawful sublicensing of a Stelara biosimilar. Meanwhile, Takeda has made a significant investment in a new BridGene partnership aimed at targeting undruggable targets. In other news, Regeneron has made strides in developing a gene therapy that can restore hearing in patients with rare genetic deafness. However, Deerfield Management claims that Alcon is hindering Aurion Biotech's IPO progress. Additionally, Trilink is offering mRNA designs that ensure reliable performance across various applications. There have also been reports of compounders suing the FDA, Reperio Therapeutics downsizing their staff, and discussions on how to support small molecule innovations in the industry. And if you missed it, recent developments include Trump threatening big pharma with tariffs, the FDA rehiring scientists, and advancements in pain treatment, RNA editing, and gene therapies being highlighted. Opportunities in neuroscience sales, regulatory affairs, and marketing are currently available for those interested. Thank you for tuning in to Pharma and Biotech Daily for the latest updates in the industry.

Show notes 1. Jeremias S. A banner year for biosimilars: The 19 FDA approvals from 2024. The Center for Biosimilars. January 21, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/a-banner-year-for-biosimilars-the-18-fda-approvals-from-2024 2. Jeremias S. FDA approves Celltrion's Avtozma as third tocilizumab biosimilar. The Center for Biosimilars. January 31, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/fda-approves-celltrion-s-avtozma-as-third-tocilizumab-biosimilar 3. Jeremias S. Senators introduce bipartisan legislation to protect skinny labeling. The Center for Biosimilars. January 2, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/senators-introduce-bipartisan-legislation-to-protect-skinny-labeling 4. Jeremias S. FTC releases second report on PBMs meddling in generic drug markets. The Center for Biosimilars. January 19, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/ftc-releases-second-report-on-pbms-meddling-in-generic-drug-markets 5. Santoro C. Earlier patent litigation could accelerate US biosimilar market entry. The Center for Biosimilars. January 9, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/earlier-patent-litigation-could-accelerate-us-biosimilar-market-entry 6. Jeremias S. Welcome Wezlana: the first Stelara biosimilar to launch in the US. The Center for Biosimilars. January 31, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/welcome-wezlana-the-first-stelara-biosimilar-to-launch-in-the-us 7. Jeremias S, Chambers JD. The banking of biosimilars: insights from a leading health economist. The Center for Biosimilars. February 4, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/the-banking-of-biosimilars-insights-from-a-leading-health-economist 8. Jeremias S. The biosimilar void: 90% of biologics coming off patent will lack biosimilars. The Center for Biosimilars. February 5, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/the-biosimilar-void-90-of-biologics-coming-off-patent-will-lack-biosimilars 9. Jeremias S. Biosimilars drive cost savings and achieve 53% market share across treatment areas. The Center for Biosimilars. January 16, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/biosimilars-drive-cost-savings-and-achieve-53-market-share-across-treatment-areas

In this week's episode, I take a look back at the movies and TV shows I watched in Autumn 2024, and rate them from my least favorite to my favorite. TRANSCRIPT Hello, everyone. Welcome to episode 230 of The Pulp Writer Show. My name is Jonathan Moeller. Today is December the Sixth, 2024, and today we are looking at my movie/TV show roundup for Fall 2024. Before we get to that, we'll have an update on my current writing projects and then we will do Question of the Week.   First up, I'm pleased to report that the rough draft of Orc Hoard is done at 78,000 words, so it'll probably end up being about exactly the same length as Half-Orc Paladin, the previous book in the series. I've also written a short story called Commander's Wrath that newsletter subscribers will get a free ebook copy of when Orc Hoard comes out and hopefully we're on track to have that out before Christmas. I'm also 7,000 words into Shield of Deception, which will be the fourth book in The Shield War series and if all goes well, I'm hoping to have that out in January or February. In audiobook news, recording is currently underway for Cloak of Masks and that will probably be out towards the end of January or perhaps February, depending on how long processing takes.   00:01:02 Question of the Week   Question of the Week is designed to inspire enjoyable discussions of interesting topics. This week's question, what do you listen to while working: genre of music, audiobooks, podcast, nothing else so you can concentrate, et cetera. No wrong answers obviously, and we had quite a few answers.   David says: I listen to audiobooks and music. Music ranges from classical to country to pop, bands and soul artists to instrumental. No rap or heavy metal or dance music or I listen to music from YouTube channels. If I have to really focus on what I'm doing, I'll turn it low so it doesn't distract.   Justin says: video game music is my first choice. It can help you grind in real life just like it does in the game. If that isn't working for me, then rock or classical music with movie soundtracks at third.   Brooks says: I tend to gravitate towards hard rock/punk rock. I have to stay adrenalized. Outside work, I'll listen to almost anything.   Michael says: I find I can't listen to words or lyrics without getting distracted by them, so instrumental music is the way to go. Usually video game music too (the Stelara soundtrack is particularly epic), movie scores (Kingdom of Heaven is one of my favorites), or Dungeon Synth, an amazing music genre I only discovered recently.   Barbara says: sometimes I play music while writing, but most of the time I prefer the silence so I can better hear the voices in my head. Of course, I prefer very specific types of music that always end up coming back no matter how much I try to stray.   Jenny says: lots of EDM and techno if words would distract me or my solid nineties pop punk angsty mix. I also have a giant one I called “I heard it in a video game” for background music. John says: When I did/could work, I enjoyed outlaw country music, particularly that from Texas. Put me in a kick butt and take names kind of mood. When you're a plumber who gets paid by the work done, not the hour, that's where one wants to be.   (A different) John says: I only listen to music when I'm working in the kitchen. I'm eclectic. Sometimes classical music, sometimes ‘80s prog rock with Hawaiian music and occasionally jazz tossed in.   Juana says: I like rock and roll from many eras. I put my eclectic music on shuffle. I also listen to movie soundtracks: Star Wars, Star Trek, Harry Potter, Animal House, et al.   Brandy says: If I'm cooking, I listen to Pandora. There's a pop ‘90s - ‘20s station. I do have a few that are specifically listed, angry or sad, one more angry German metal or Mongolian throat metal, the other more goth and industrial. I read books instead of listening. If I'm proofing, I usually have something on in the background. Today it's Sanctuary Season One.   Morgan says: ADHD means I jump around a lot on what I'm listening to depending on the day, but audiobooks- usually fantasy or horror. Podcasts- Pathfinder actual play podcasts, horror podcasts, and wrestling/gaming news podcasts. Music, whatever artist/album I'm obsessing over at the time, but usually prog rock, metal, or rap.   Matthew says: I always have my iPad for background noise. If I'm particularly invested in getting chapters done, I'll put on something largely audible.   Gary says: audiobooks, podcasts, worship music, Christian hard rock.   Bob says: Retired now, but when I was working I didn't listen to anything-needed to concentrate on what I was doing. When paying bills, I sometimes have some Morse Code on in the background (one of my previous means of paying the bills). On long car trips, it's nice to have some distraction -whatever radio station I can find, preferably one with a story. In truck stops, we used to find some stories on disc that had the actors doing the voice of the characters and some of them were pretty good.   For myself, I almost always listen to music while I'm working and that genre is usually soundtracks and video games, movies, and TV shows (in that order) that I liked, which makes it difficult to discuss music with people, I have to admit. I do listen to podcasts when I'm working outside, so long as I'm not using a power tool that requires earplugs for safe operation (which sadly seems to be most of the time).   00:04:42 Main Topic: Autumn 2024 Movie/TV Review Roundup   Now on to our main topic, the review roundup of the movies and streaming shows I watched in Autumn 2024. I was going to do a combined Autumn/Winter 2024 one, but it was getting a bit too long, so Winter 2024/2025 will be its own post in a few months. I seemed to watch a lot of time travel movies this time around and quite a few with Space Magic. As ever, the grades are totally subjective and based on nothing more than my own thoughts and opinions. Now let's take a look at the movies and streaming shows from least favorite to most favorite.   First up is Escanaba in Da Moonlight, which came out in 2001 and it is a surrealist comedy about hunting traditions set in Michigan's Upper Peninsula. 42-year-old Reuben Sodi is the only man in his family who has never shot a buck, so when he complains about this to his Native American wife, she casts a spell to help Ruben bag his first buck, which results in a very bizarre nighttime journey/vision quest. This includes UFOs, visitations by nighttime spirits, and a Department of Natural Resources officer having a mental breakdown. This was a funny movie, but it was definitely very weird and even more specific. If you're at all familiar with the hunting culture of Upper American Midwest, you'll get the humor. If you're not familiar with it, this will be like watching a movie from another planet. Overall grade: C.   Next up is Looper, which came out in 2012. I didn't actually like this movie very much, but I respect how well done it was. Joseph Gordon Levitt plays Joe and is a type of assassin called a looper living in the US in 2044. About 30 years after 2044, time travel is invented but immediately outlawed. Since it's difficult to get away with murder in 2074 due to advanced technology, crime syndicates have taken to sending people they want eliminated back in time to 2044 where the loopers immediately execute the target in exchange for a big fat payout. Loopers can live like kings, but there's a price. Eventually the loop is closed and the looper's future self is sent back to be killed by his past self. Failure to comply results in an extremely grisly fate at the hands of the syndicate. Joe, being a hardened killer and drug addict, is fine with all this and even helps turn in a fellow looper who failed to close his own loop. Then Joe's future self arrives. Joe is about to kill Future Joe (played by Bruce Willis), but Future Joe escapes and Present Joe has to hunt down and kill Future Joe if he wants to survive.   In the process, Present Joe stumbles across the farm of a woman named Sarah (played by Emily Blunt) and her young son Sid. Present Joe realizes that future Joe has traveled back to kill the child, Sid, who will be responsible for the death of Future Joe's wife in the future. Despite everything he's done, Present Joe is not okay with this and gears up to help Sarah defend Sid from Future Joe. This movie was on the very dark side of noir filmmaking: no good characters, essentially only various degrees of bad people trying to navigate their way through the maze of time crimes. I did strongly dislike how fundamentally nihilistic the movie was and the addition of telekinesis did seem like kind of a plot crutch. There is also some unnecessary nudity. Rian Johnson is actually an excellent filmmaker. Knives Out and Glass Onion were both very good, but I cannot imagine how someone will watch Looper and think, hey, this guy is a good choice for a Star Wars movie. Overall Grade: B-   Next up is Agatha All Along, which came out in 2024. It was extremely well written and well-acted. You almost have to watch it twice just to admire how well put together the plot was. I wasn't expecting to like Agatha All Along, but it is an excellent example of writing a show with a villain protagonist and actually pulling it off. The show is also a good example of something I've talked about before on the podcast and the blog: characters can be likable, emotionally sympathetic, or both. It's sometimes tricky to write a character who's both, unlikable but emotionally sympathetic. By contrast, Agatha Harkness is an excellent example of a character who's both likable and highly, highly unsympathetic. Agatha All Along is indeed a show with a villain protagonist, but Agatha is charismatic enough to remain likable even though she's unquestionably an absolute monster who deserves every bit of suffering she endures.   Actress Kathryn Hahn deserves major credit for making someone as evil as Agatha so charismatic. Agatha retains just enough of a sliver of sympathy to keep the audience from turning on her, but even when she shows flashes of humanity, beneath that there are even more layers of monster. She also does a very sort of a modern Doctor Who/ Sherlock thing where she talks very fast and puts up a flippant and silly facade, but she's actually calculating things several steps in advance and manipulating everyone around her to her final goal. Anyway, the plot of Agatha All Along is that Agatha finally breaks free from the spell of the Scarlet Witch placed on here at the end of Wandavision. However, Agatha doesn't have any magic left, which is a major problem for her because she has very many enemies who very much want to see her dead as soon as possible, but then a mysterious teenager turns up and asks for Agatha's help. He wants to walk the legendary Witches' Road and it has said that someone who walks the road and survives to the end will receive their heart's desire. Since Agatha doesn't have any other options and she has some major enemies, she agrees. Agatha, the teenager, and the Witches' Road itself all have very dark secrets and their reveal makes for some major drama. As I mentioned, the show was very well written and acted. I suspect that may be the secret for movie or TV success in the 2020s economic climate: good actors, an excellent script, and keep your costs down. Overall grade: B   Our next movie is Field of Dreams, which came out in 1989. An Iowa farmer discovers he's a very specific kind of necromancer, like how sports medicine is a specific field of study. Maybe sports necromancy is a specific subclass for evil wizards or something. All joking aside, the main character is Ray Kinsella (played by Kevin Costner) and he's walking his cornfield one day and he hears a mysterious voice tell him “If you build it, he will come.” Ray builds a baseball field in one of his cornfields and began speaking to the ghost of Shoeless Joe, a popular baseball player who died in 1951. Soon a lot of other ghosts arrive and start playing baseball as well. The mysterious voice starts urging Ray to “ease his pain” and Ray concludes this must means Terrance Mann (played by James Earl Jones), an activist writer from the sixties who dropped out of the public eye and is living in seclusion. So Ray starts on a cross country trip to persuade Mann to come to his baseball field. This movie is really perhaps the ur-example of the Feel-Good Eighties Movies and maybe a Baby Boomer movie. The characters speak with near religious reverence for the ‘60s, baseball is the Great American Pastime, and Ray really wants to heal his relationship with the father he rebelled against back in the ‘60s. The best part of the movie was unquestionably James Earl Jones' character and his performance as he resigns himself to Ray's craziness and then starts to believe in it was pretty great. Overall grade: B Next up is Holiday, which came out in 1938. Holiday is a romantic comedy from the 1930s. Cary Grant plays Johnny Case, who has fallen in love with Julia Seton, the daughter of a wealthy New York banking family. However, his more individualistic outlook soon puts him at odds with Julia's more traditionalist family, though this draws the attention of Julia's elder sister Linda (played by Katharine Hepburn). It felt a bit like watching a play and a little research revealed that it was indeed based on a play from 1928, which may be why the film didn't do so well when it originally came out, though it is regarded as a classic today.   Viewers in the Great Depression era would probably find it difficult to sympathize with a man who wanted to turn down a well-paying job at a bank, not out of moral objections to the bank's business practices, but because he would feel constrained. The Seton family is played as eccentric and somewhat troubled, but not as buffoons or villains as rich people were often portrayed in other 1930s movies. Good performances and worth watching as a classic, though sound technology has improved quite a bit in the last 90 years, so you probably will want to watch it with the captions on. Overall grade: B   Next movie is Twisters, which came out in 2024. This is basically the same movie as Twister from back in 1995, but with some of the plot of Pride and Prejudice bolted on. Kate Carter (played by Daisy Edgar-Jones) is an Oklahoma storm chaser with her boyfriend and best friends. One day, one of their storm chases goes horribly wrong, killing Kate's boyfriend and most of their friends. Five years later, Kate is working for the National Weather Service in New York when her old friend Javi, the other survivor of that storm, asks for her help testing a new radar tracking system. Kate reluctantly agrees and they return to Oklahoma and crosses horns with storm YouTuber Tyler Owens (played by Glenn Powell) who makes videos of his truck shooting fireworks into tornadoes. Naturally, Kate and Tyler immediately misunderstand each other in the same way as in Pride and Prejudice but are forced to work together when it turns out that Javi's company might have ulterior motives. I thought this was a thoroughly enjoyable summer popcorn flick. Given how both Covid and the 2023 writers' strike hit this movie's production like two successive freight trains, it's astonishing it turned out so well. Overall grade: A-   Next up is The Rings of Power Season 2, which came out in 2024. I have the same attitude towards this as I do with Starfield. I really like it. In fact, my Xbox told me I played Starfield for 270 hours in 2024, but I get why some people do not. This show is essentially very elaborate fan fiction. The Lord of the Rings movie trilogy, despite the changes from the book, was still recognizably The Lord of the Rings. The Rings of Power is almost entirely its own thing. Nevertheless, I enjoyed this for a couple of reasons and hope it continues. First, it's nice to have an epic fantasy TV series that's not a nihilistic pornographic torture fest like Game of Thrones and House of the Dragon and is more competently executed than Disney's ill-fated Willow Series.   Second, all things must be taken in their context. What do I mean by this? Perhaps a food comparison will illustrate the point. The book the Lord of the Rings is like Kobe beef prepared by the finest chefs in the world, the sort of experience you get maybe once or twice in your life if fortune smiles upon you. The Lord of the Rings movie trilogy is like a high-quality supermarket steak grilled in the backyard by someone who's pretty good at it. The Rings of Power is like McDonald's, but there are times when you really want some McDonald's. In fact, I kind of want a Big Mac after saying all of that, but The Rings of Power is really good McDonald's, the kind of McDonald's you have after driving the car for 250 miles without stopping across one of America's flatter and less populous states. The only place to eat for like a hundred miles in any direction is this McDonald's in the same building as a gas station, so you stop and don't expect very much, but it turns out the fries are crispy and salty and the nuggets are just right.   I don't think it's surprising that The Rings of Power has had such a mixed reception. The Venn diagram of “enjoys Lord of the Rings” has some wildly divergent circles to it and that is a testament to the fact that the Lord of the Rings is such a great work of literature that so many people from so many very different ideological identity groups enjoy and identify with the book. Even ideological identity groups that are mortal foes agree on their approval of the Lord the Rings. So naturally each different group has its own strong opinion of what an adaptation should look like.   With that very long-winded introduction out of the way, I liked season two and I thought it was an improvement over Season One, a lot more narrative tension. Season One perhaps spent too much time setting the table and building context, but Season Two works well in making Season One better in hindsight. The Rings of Power version of Galadriel is improved in Season Two because she was one of the few characters in Season One able to throw off Sauron's mental domination and seduction. The highlight of the season was the toxic dynamic between Sauron and Celebrimbor.  Actors Charlie Vickers and Charles Edwards did an amazing job portraying the slow-moving disaster that Sauron and Celebrimbor's collaboration would create, two intellectual equals working together to create something great, but nonetheless, Sauron twists everything to his own ends. Their final scene together was just astonishingly good. The portrayal of Sauron is both very modern and true to Tolkien, a destructive narcissist who actually believes whatever lies he's speaking at any given moment. He really, truly believes he's going to heal Middle Earth, no matter how many people he has to kill to do it. The scenes with Prince Durin, his father, and one of the dwarven rings of power were great as well. It had the same sort of feel to it as an adult child watching with horror as a beloved parent succumbs to a drug addiction. The best new character the show created (in my opinion) is Adar, one of the progenitors of the orcs. Tolkien himself could never really decide on the origin of the orcs and came up with different thoughts throughout his lifetime. When editing The Silmarillion, Christopher Tolkien settled on the corrupted former elves version, which seems to be what his father had been leaning towards anyway. Rings of Power takes that to its logical conclusion. Adar wants his orcish progeny to live free of the dark lords Morgoth and Sauron, which makes sense because in the books, the orcs hated Morgoth and Sauron and only served them out of fear. Indeed, in The Lord of the Rings, Sauron seems to have secret police and informers among the orcs to keep track of their loyalties. Since the show displays how twisted and cruel Sauron really is, it makes sense that Adar is willing to go to any lengths to stop Sauron, no matter how extreme. The orcs are still monsters, including Adar himself, but they're monsters who want to be free of an even greater monster than themselves. If you've read The Silmarillion or The Lord of the Rings, you'll know all the characters' efforts are doomed to failure, especially Adar and Celebrimbor's, which lends an air of inevitable tragedy to everything that happens. I know some people were mad that Tom Bombadil was basically Wizard Yoda, but I thought it worked. Tom Bombadil is so inscrutable of a character that he can really do whatever he wants so long as he's inscrutable. It was also great how composer Bear McCreary wove a variation of Sauron's theme throughout the show. The soundtrack was A+ work in my opinion. Overall, I enjoyed the show and would like it to continue. If you know the difference between Fëanor, Finwë, Finrod, Felagund, Finarfin, Findulias, Fingon, and Fingolfin (without having to look it up), and in fact have everything about them from The Silmarillion memorized, you'll hate this show. But I think it's worth watching. Overall Grade: A-   Next up is Casa Bonita Mi Amor, which came out in 2024. Way back in the 1990s I saw an episode of Frasier where Frasier and his brother Niles decide to buy a restaurant. A series of hilarious cascading disasters result. At the time I decided I never wanted to own a restaurant and every piece of both factual information and fictional media I have consumed since has not changed this decision. Casa Bonita Mi Amor definitely will not challenge that decision. Apparently, Casa Bonita was a beloved theme restaurant in Colorado that went out of business during Covid. Trey Parker and Matt Stone, creators of South Park, decided to buy the restaurant themselves and reopen it. They budgeted $3.6 million for the restoration of the building. Costs soon swelled to $40 million and the problems were still only just beginning. This is an excellent and entertaining example of the “rich man buys restaurant, soon finds himself over his head” genre of documentary filmmaking. Overall grade: A   Finally, my two favorite things I saw in Autumn 2024 and the first of them is the movie Frequency, which came out in 2000. It's another variant on a time travel story, but I like this one considerably better than Looper. Frank Sullivan is a firefighter and devoted family man living in New York circa 1969. His son John is a police detective living in the house 30 years later in 1999 with emotional problems because he never got over his father's tragic death in a dangerous fire 30 years earlier in 1969.   When the son of a friend stumbles across his father's old ham radio, John lets the kid goof around with it. Later that night, John starts talking to someone on that radio and to his astonishment realizes he's talking to his father from 30 years ago on the same ham radio. Desperate, John tries to warn Frank about the fire that kills him and it works. Frank survives the fire and instead of dying 1969, instead dies in 1989 from lung cancer due to a pack a day habit. The scene where history changes and John suddenly realizes what has happened was pretty great, but this isn't the ending. We're only 40% of the way through the movie. John successfully managed to put right what once went wrong.   However, in doing so, he accidentally also put wrong what once went right. His mother is a nurse and in the original timeline was on bereavement leave the day after Frank's death. In the new timeline, Frank is okay, so she goes to work and saves a patient who otherwise would've died in medical error and the patient happens to be the deadly serial killer known as the Nightingale. To his horror, John realizes that The Nightingale is now free to continue his murder spree and his new target is John's mother and Frank's wife.   As I've mentioned numerous times before, I'm not really a fan of time travel stories, but this one was quite well done. Interestingly, the plot structure was similar to Avengers Endgame. The Avengers go back in time to steal the Infinity Stones to undo Thanos' Snap, but Past Thanos figures out what's going on and follows the Avengers back to the present and attempts to make things even worse than they already are. John manages to save Frank from the fire, but this means the Nightingale serial killer survives and might create a worse present than the one John already has, so that really adds an altogether excellent element of dramatic tension to the entire movie. As one amusing side note, this movie shared Field of Dream's reverence for baseball as the Great American Pastime and John manages to convince Frank he's telling the truth about their time travel radio by accurately predicting the outcome of baseball games. Overall grade: A Now the second favorite thing I watched in Autumn 2024, The Grand Tour: One for the Road, which came out in 2024. I admit that when I started self-publishing in 2011, I knew absolutely nothing about the contemporary United Kingdom, like I couldn't even told you whether the UK used the Pound or the Euro. When I started getting book royalties from Amazon UK, let's just say I learned about currency conversion rates really fast, but as UK book royalties fluctuated as they do, I started reading the UK news since when there's an election or major news event in the UK, book royalties tend to drop for a few days after the same way they do when something similar happens in the US. Because of that, I saw the news article when Jeremy Clarkson was fired from Top Gear in 2015 for punching out a producer. At the time, there were some seasons of Top Gear on Netflix, so I was curious and started watching and was thoroughly entertained.   When Grand Tour started on Amazon, I started watching that as well and I was also thoroughly entertained, but all good things must come to an end. Jeremy Clarkson, Richard Hammond, and James May go on one last road trip adventure across Zimbabwe. The usual hijinks ensue for one last time, and it was a fitting end to Top Gear/The Grand Tour. I'll miss the show, but I am grateful for over a decade of entertainment from Top Gear/The Grand Tour and from the various spinoffs like Clarkson's Farm and James May's travel show. Overall grade: A   So that is it for this week. Thank you for listening to The Pulp Writer Show. I hope you found the show useful. A reminder that you can listen to all the back episodes on https://thepulpwritershow.com. If you enjoyed the podcast, please leave your review on your podcasting platform of choice. Stay safe and stay healthy and see you all next week.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Takeda, Roche, and Gilead have recently made significant deals in the pharmaceutical industry. Takeda's investment of up to $1.3 billion in Keros' blood cancer anemia drug is making waves, potentially challenging Bristol Myers Squibb. Roche has joined forces with Cour in a deal focused on autoimmune diseases, valued at over $900 million. Meanwhile, Gilead is reentering the ADC space with a potential $415 million license agreement.In other news, Intra-Cellular is seeking approval for Caplyta in major depressive disorder, a move that could result in $1 billion in sales. Unfortunately, Alligator has been forced to reduce its staff by 70% due to capital constraints. On a brighter note, Biocon has received FDA approval for a biosimilar to J&J's Stelara, and Applied Therapeutics is making strides in the fight against deadly brain cancer.However, Bluebird's gene therapy Skysona is currently under FDA safety probe for hematologic malignancies, raising concerns within the industry. Despite this setback, the pharmaceutical industry as a whole continues to see growth and innovation on multiple fronts.

No podcast ‘Notícia No Seu Tempo', confira em áudio as principais notícias da edição impressa do jornal ‘O Estado de S.Paulo' desta quinta-feira (24/10/2024): Empresas farmacêuticas e fabricantes de medicamentos de referência e de genéricos travam uma disputa acirrada na Justiça em torno de patentes de 62 medicamentos – entre eles, o Saxenda, de controle da diabetes e rival do Ozempic em tratamentos para perda de peso, e o Stelara, para doenças autoimunes. As donas das fórmulas originais querem manter a extensão do prazo de vendas exclusivas de seus remédios para além dos 20 anos legais de proteção das patentes. Mas uma mudança de entendimento do Supremo Tribunal Federal (STF), de 2021, é um empecilho para isso. A briga entre esses dois grupos começou a esquentar no contexto da pandemia de covid-19, quando ganhou força entre governos e políticos a ideia de acelerar e baratear tratamentos médicos.  E mais: Política: Estabilidade de Nunes em pesquisas já leva PT e PL a tentar atrair MDB Metrópole: CAC com esquizofrenia mata irmão, pai e PM e fere 9 em Novo Hamburgo Internacional: Brics aprova adesão de 13 países, sem Venezuela, apesar da visita de Maduro Caderno 2: Antonio Cicero: Poeta viveu em diálogo com a filosofia e a música  See omnystudio.com/listener for privacy information.

Audio roundup of selected biopharma industry content from Scrip over the business week ended 18 October 2024. In this episode: J&J looks to Tremfya as Stelara declines; Pfizer's Hympavzi may find hemophilia B niche; big pharma's cell and gene therapy realities; M&A took a holiday in Q3; and last rites for Sanofi's RIPK1 drug. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-CMKHTUFVBBDQ3DSTX3KJALGCQI/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

It's that time again: earnings season. Q3 calls started out with a bit of a snore from J&J, which did beat analyst expectations but announced no big shakeups or surprises. As expected, the company saw shrinking revenue for its blockbuster Stelara, which just lost to Lilly's Omvoh in a head-to-head clinical trial in Crohn's disease. Last week, a concerning study was published regarding seven children who developed blood cancers after being treated with bluebird bio's gene therapy Skysona. This publication comes at a time when the company is struggling to regain its share price, which has dropped below the Nasdaq minimum bid price requirement. The bad news about Skysona also fits with another trend BioSpace covered this week: accelerated approvals gone wrong. In other news, Sanofi is following some of its pharma peers and looking to sell its consumer healthcare unit. This follows similar moves from J&J, which spun off Kenvue last year, as well as GSK, Pfizer and others. And Senator Elizabeth Warren (Mass.-D) is upping the pressure on Novo in relation to its acquisition of Catalent, penning a letter to the Federal Trade Commission voicing concerns about the potential effects of such a deal, should it go through. Finally, bispecific antibodies make a comeback in oncology.

Show notes 1. Sandoz Reports 29% Growth in Biosimilar Revenues for First Half of 2024 2. Pure-Play Biosimilar Company Reports 10-Fold Revenue Increase for First Half of 2024 3. Formycon Reports €26.9 Million Revenue for First Half 2024, Driven by Biosimilars 4. CMS Announces New Drug Prices Under the IRA, Including for Stelara and Enbrel 5. FDA Approves Biosimilar Enzeevu for Eye Conditions 6. Manitoba Adopts Biosimilar Switching Policy 7. Eye on Pharma: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results 8. Vizient Report Projects Price Inflation for Originators With Biosimilars in the Pipeline

In this episode of HR Benecast, Mike Stull and Eric Dublikar cover your pharmacy and employee benefits questions including:   What's new in federal and state pharmacy benefit legislation. How Employers Health is working to help clients manage changes to their PBM plans.  What the switch to biosimilars for Humira and Stelara means for plan sponsors?  What impact are GLP-1s having on employer drug spend? Trends in GLP coverage for weight loss.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. The FDA recently approved a biosimilar of Stelara from Alvotech and Teva, set to launch early next year. Johnson & Johnson reported mixed sales performance for new multiple myeloma drugs, with Tecvayli sales exceeding expectations and Carvykti underperforming. Roche also released survival data for a new lymphoma drug, potentially giving it an edge over a competitor. The US government sued Regeneron for allegedly falsely reporting prices on the blockbuster eye drug Eylea. Other topics covered in the newsletter include drug pricing trends, diversity in clinical trials, and the weight loss drug market.In order to successfully execute health advertising campaigns, marketers need to take a proactive approach by targeting health audience segments online. Actionable insights are provided to maximize the impact of media investment through tips such as implementing a test and learn strategy, scaling results quickly, and asking tough questions to potential health targeting partners. Veeva Crossix is highlighted as a company that implements these tactics to reach consumers throughout the patient journey.Abbott CEO Robert Ford highlighted new and upcoming products during an earnings call, emphasizing the recently approved Triclip valve as a significant opportunity for growth. The FDA issued a warning to Soulaire for selling a device outside of authorized uses. Lilly's obesity drug showed benefits in a sleep disorder study, indicating potential new uses. Johnson & Johnson's $30 billion spending spree on companies like Abiomed, Laminar, and Shockwave Medical may continue. Additionally, Philips entered into a consent decree with the FDA, where the agency will use rare powers to require repairs, replacements, or refunds for recalled respiratory machines.Eli Lilly's weight-loss drug Zepbound has shown effectiveness in treating sleep apnea, leading the company to prepare for a label expansion. Amylyx faced a setback with the failure of its ALS drug Relyvrio, leading to layoffs and market withdrawal. Despite this, the company saw success in treating Wolfram syndrome. Sage Therapeutics also announced the discontinuation of its Parkinson's disease program after disappointing results in phase II trials, shifting focus to Huntington's and Alzheimer's diseases.The medical device industry is increasingly incorporating AI and digital health technologies to improve performance and outcomes. Overall, the medtech sector is evolving rapidly with new products and technologies driving growth and innovation.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Today, we have several news updates from the industry.## Johnson & Johnson (J&J) is focusing on newer medications to offset the patent cliff for its drug Stelara. The company plans to rely on its cash position and incremental dealmaking to combat incoming competition. This strategy shows J&J's determination to stay ahead in the market.## Eli Lilly's gene therapy success in treating hearing loss has brought attention to the potential of gene therapies in this area. Other companies, including biotechs in China and Regeneron in the US, are also targeting the same drug target. The success of these therapies opens up new possibilities for treating hearing loss.## Novo Nordisk has struck another obesity drug deal, partnering with startup Eracal Therapeutics to add another prospect to its pipeline of weight loss drugs. This partnership expands Novo Nordisk's offerings in the obesity drug space, showing their commitment to tackling this global health issue.## After a record run, fewer biotech companies are going public. This article explores how these companies are performing and highlights upcoming IPOs from CG Oncology and Arrivent Biopharma. The biotech industry is experiencing a shift in IPO trends, which has implications for investors and the market as a whole.## The FDA has ordered new cancer warnings for CAR-T therapies. The agency modified its warning for Gilead's Tecartus to reflect that none of the T cell malignancies in question had occurred in Tecartus-treated patients. This regulatory update emphasizes the importance of accurate information and transparency when it comes to cancer therapies.Moving on to other news,## Walgreens is reportedly exploring the sale of Shields Health Solutions, a specialty pharmacy, which could be valued at more than $4 billion. However, this potential deal might slow down the healthcare segment's drive towards profitability. It will be interesting to see how this sale plays out and its impact on the healthcare industry.## Lawmakers are also pressing Steward Health Care to address reports of "grave financial distress" and provide plans to ensure that the communities served by Steward's hospitals are not abandoned. This highlights the importance of financial stability in the healthcare sector and the need for accountability.## HCA subsidiary Surgery Ventures has acquired two surgery centers in Texas, following other recent acquisitions in the state. This shows a trend of consolidation in the healthcare industry, as companies seek to expand their reach and capabilities.## Elevance, a payer, managed to curb the growth of medical costs last year and expects to do the same in 2024. However, some analysts view this assumption as "aggressive" due to persistent higher utilization among seniors. This raises questions about the long-term sustainability of cost containment efforts in healthcare.In other news,## Johnson & Johnson (J&J) has been facing legal issues related to its talc baby powder products allegedly causing cancer. The company has agreed to settle the lawsuits for about $700 million, but investors are concerned about the lack of clarity regarding future risk. Despite J&J's strong earnings reports and annual sales nearing $100 billion, investors may choose to invest elsewhere due to the potential for more legal troubles. J&J's strategy for 2024 will focus on newer medications to offset the patent cliff for its drug Stelara. This shows their commitment to innovation and adaptation in a challenging market.## The FDA is undergoing a major reorganization that may affect its regulatory efficiency. This development could have implications for drug approvals and patient access to new treatments. It will be important to monitor how this reorganization unfolds and its impact on the industry.## Finally, a poll revealed that 67% of readers believe t

Johnson & Johnson (JNJ) convened its earnings call on Tuesday, January 23rd, 2024, providing insights on the state of the company and the direction it hopes to take in the near future. Joaquin Duato, CEO of Johnson & Johnson, expressed contentment with the company's performance, particularly within their pulmonary franchise. "Overall, we're very happy with the trajectory of our pulmonary franchise in 2023. And we expect a similar trajectory as macitentan, OPSUMIT, and Tadalafil become standard of care", Duato stated during the earnings call. The year 2023 saw Johnson & Johnson report full-year sales of $85.2 billion, reflecting a growth rate of 7.4%. According to the earnings call, this performance was largely attributed to key products in their Innovative Medicine business such as DARZALEX, ERLEADA, STELARA, and TREMFYA, contributing substantially to the company's Oncology division. Following the recent launch of CARVYKTI, TECVAYLI, TALVEY, and SPRAVATO, Johnson & Johnson has broadened its scope in the oncology market. The firm also mentioned on the call that despite the ongoing recovery from the global pandemic, they marked notable increases in electrophysiology, heart recovery, surgery, orthopedics, and Vision, surpassing pre-pandemic levels in their MedTech business. Johnson & Johnson also shared its prospective plans and investment strategies. Acknowledged in the call, the company intends to allocate $15 billion towards research and development in 2023, underlining their commitment to innovation and pipeline advancement. In an effort to strengthen their oncology portfolio, JNJ plans to pursue strategic acquisitions, notably Ambrx, while simultaneously focusing on commercial execution, product differentiation, and expansion within the MedTech sector, as stated in the earnings call. The Johnson & Johnson earnings call highlighted steady financial performance and constant growth. With a focus on research and development, the company aims to introduce innovative products and engage in strategic acquisitions to support long-term growth and sustainability. As mentioned in the earnings call, amidst a competitive healthcare industry, the attributes that distinguish Johnson & Johnson are their emphasis on innovation and their dedication to meeting the evolving needs of patients globally. Remaining cautiously optimistic, it's important to note that these are plans based on the current circumstances and market trends, the actualization of which is dependent on a plethora of internal and external factors. JNJ Company info: https://finance.yahoo.com/quote/JNJ/profile For more PSFK research : www.psfk.com  This email has been published and shared for the purpose of business research and is not intended as investment advice.

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. In today's episode, we have several news stories to cover. Let's dive in.## Barrier to Accessing Cell and Gene TherapiesA webinar is being promoted that focuses on the barriers to accessing cell and gene therapies and strategies for improvement. The webinar discusses the importance of patient services in successful launches of these therapies, emphasizing the need for flexible patient support. Cell and gene therapies are one of the fastest-growing sectors in therapeutics, but patients face unique challenges in accessing them that pharma brands must address. This content was created by members of the StudioID expert network for a sponsor of the publication.## Global Oncology Trends and Clinical Trial StrategiesAn insight brief is being promoted that discusses global oncology trends and their impact on clinical trial strategies. It highlights that 70% of the research and development pipeline in oncology is driven by biotech companies. The brief covers key areas such as early phase trial design, platform design trials, and diversity planning in protocols. It provides insights on how global oncology trends are affecting sponsors and offers strategies for success. The text also mentions opportunities for industry professionals to reach a wide audience through Biopharma Dive.## FDA Comments on Lab-Developed Tests RuleThe FDA has received over 19,000 comments on its proposed rule for lab-developed tests (LDTs). The American Clinical Laboratory Association expressed concerns about the proposal in a 107-page document. Baxter has issued a safety notice regarding syringe infusion pump errors, providing reinforced guidance to mitigate risk. Intuitive, a robotic surgical systems manufacturer, has launched a $150 million venture capital fund to support early-stage companies focused on healthcare access. ResMed, a sleep apnea device manufacturer, is focusing on growing demand for its products with a new executive team. Nevro, a medical device company specializing in chronic pain treatment, has acquired Vyrsa, a low back pain company, for $40 million.## Manufacturing Strategies and Racism in HealthcareAn infographic highlights key manufacturing strategies to boost medtech revenue. Additionally, a survey finds that Black Americans expect to face racism in the doctor's office. Medtech Dive provides in-depth journalism and insight into the most impactful news and trends shaping the medical technology industry.## Potential Merger and Job CutsA potential merger between health insurers Cigna and Humana could face regulatory hurdles due to antitrust concerns. Mass General Brigham has made cuts to its tech division, affecting fewer than 20 employees. The Centers for Medicare and Medicaid Services (CMS) has stated that states could lose funding due to issues with Medicaid redeterminations. Fitch Ratings predicts a deteriorating outlook for nonprofit organizations in 2024. A healthcare data breach at a New York-based imaging center may have exposed the personal information of over 600,000 individuals.## Johnson & Johnson's Drug Sales and CEO AppointmentJohnson & Johnson is pitching investors on the potential sales growth of its cancer and immune disease drugs. CRISPR is shifting its focus from cancer to autoimmune diseases in its cell therapy plans. BrainChild Bio aims to develop cancer drugs, starting with pediatric brain tumors. Pfizer has completed enrollment in a clinical trial for its Lyme disease vaccine. BIO has appointed John Crowley as its new CEO to challenge Medicare's new drug pricing powers.## Johnson & Johnson's Sales Growth and CRISPR's PipelineJohnson & Johnson expects sales growth to slow in 2024 as its blockbuster drug Stelara faces competition. CRISPR is reorganizing its CAR-T pipeline ahead of the FDA's landmark decision. Roche's BTK inhibitor multiple sclerosis program i

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.In today's episode, we have several news updates from the industry. Let's dive right in!First up, we have a webinar titled "Navigating Preclinical Drug Development Challenges with Lipid-Based Formulations." This webinar discusses how biopharma teams are utilizing lipid-based formulations (LBF) to improve the bioavailability of challenging molecules and reduce the transition time and cost requirements for clinical trials. The highlights of the webinar include strategies for dosing lipid formulations in preclinical models, key considerations for improving bioavailability through LBF, and the regulatory and technical nuances involved in transitioning preclinical LBF to viable clinical dosage forms.Next, we have a case study from Cambrex on their process to enable GMP production under tight time pressure for a first-in-human clinical trial. This case study highlights the importance of route development and designing synthesis for GMP production. Cambrex's experts successfully developed a robust and high-yield process to enable GMP production within a tight timeline for a first-in-human clinical trial.Moving on, Biogen and Sage have set the price of their postpartum depression pill at $15,900, which is significantly lower than initial predictions. This move aims to make the treatment more accessible to patients. Additionally, obesity drug biotech startup OrsoBio has raised $60 million in a series A funding round to develop new therapies for obesity and related metabolic disorders.In another news update, Anne Wojcicki, CEO of 23andMe, discusses the company's transition into a "full-fledged biotech" in an in-depth interview. Wojcicki explains how 23andMe is venturing into drug research and development, going beyond its initial focus on at-home genetics testing. Ventyx, a biotech company, has revised its plans for its tyk2 drug after lackluster study data, and Bristol Myers is paying $100 million for access to a blood and bone marrow cancer drug developed by Orum Therapeutics.Shifting gears, the Biden administration is proposing a rule to cap broker payment in Medicare Advantage (MA) plans in Massachusetts to prevent marketing misconduct. Kaiser Permanente reported a rebound in investment and operating income in Q3, Envision Healthcare has emerged from bankruptcy restructuring, and Surescripts has acquired drug alternatives company ActiveRadar.Hospitals are also facing challenges in preparing for extreme weather events caused by climate change. Financial and data challenges are making it difficult for hospitals to develop effective disaster planning strategies. In other news, Cigna is reportedly exploring the possibility of shedding its Medicare Advantage business, and there is an ongoing battle over drug prices between Secretaries Becerra and Azar. A new California law offers protection from steep ambulance bills.Moving on to the pharmaceutical industry, Novartis has signed a potential $1.3 billion deal with Chong Kun Dang Pharmaceutical for the global rights to develop an oral HDAC6 inhibitor. Ventyx Biosciences has decided to discontinue the development of its psoriasis candidate despite positive results in a phase II study. Vertex Pharmaceuticals reported third-quarter revenue of $2.48 billion, falling short of expectations. The Department of Health and Human Services is considering removing Johnson & Johnson's psoriasis treatment Stelara from Medicare drug price negotiations.Next, we have an article discussing Anne Wojcicki, CEO and founder of 23andMe, and her ambitions to disrupt the healthcare industry through genomics. Wojcicki's interest in healthcare began during her childhood, and she has positioned 23andMe as a leader in direct-to-consumer genetic testing and genetic data partnerships with pharmaceutical companies. The article highlights an in-depth interview with Wojcicki, wher

Summary: Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast   Here are the highlights: Pembrolizumab (Keytruda) has received FDA approval for the treatment of metastatic biliary tract cancer, both in combination with chemotherapy and as a monotherapy. The approval is based on the positive outcomes of the KEYNOTE-966 trial, where patients receiving pembrolizumab plus chemotherapy demonstrated a statistically significant improvement in overall survival compared to those receiving a placebo with chemotherapy. Common adverse reactions included hematologic abnormalities, pyrexia, fatigue, cholangitis, and hepatic enzyme elevations. Approval was granted to Merck. Secukinumab (Cosentyx) has gained FDA approval for the treatment of moderate-to-severe hidradenitis suppurativa (HS), making it the first FDA-approved IL-17A inhibitor for this condition. Approval is based on results from the SUNSHINE and SUNRISE trials, showing significant improvements in response rates in HS patients treated with secukinumab compared to placebo. Ustekinumab-auub (Wezlana) has been granted FDA approval as an interchangeable biosimilar for Stelara, offering treatment options for multiple inflammatory diseases. It is indicated for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adult patients, as well as pediatric patients with plaque psoriasis and psoriatic arthritis. Vonoprazan (Voquezna) has received FDA approval for the treatment of erosive esophagitis (GERD). As a potent potassium-competitive acid blocker (PCAB), it offers an alternative to proton pump inhibitors (PPIs). Approval is based on the PHALCON-EE study, where vonoprazan demonstrated noninferiority to lansoprazole in healing GERD. Abatacept (Orencia) has been expanded for use in pediatric patients aged 2 years and older to treat psoriatic arthritis. Originally approved for rheumatoid arthritis in adults in 2005, abatacept was also approved for adult psoriatic arthritis in 2017. Exa-cel, a CRISPR-based therapy developed by CRISPR Therapeutics and Vertex, is under FDA review for sickle cell disease. The advisory panel has found it safe for clinical use, with potential approval expected in December. Exa-cel aims to alleviate sickle cell symptoms through gene editing technology Intro and outro music Garden Of Love by Pk jazz Collective  

FDA urge immediate discontinuation for eye drop products; safety alert issued for the pediatric Moderna COVID-19 vaccine; novel heartburn medicine approved; Stelara biosimilar approved; and an antibody to prevent fentanyl overdose gets fast tracked.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Bayer has recently opened a new plant in California to produce cell therapies, specifically a Parkinson's disease treatment being tested by its subsidiary Bluerock. This is a significant step forward in the field of cell therapy development.Meanwhile, Sana, another cell therapy developer, is implementing cost-saving measures, including layoffs and delaying certain research projects. These actions are aimed at ensuring the company's financial stability.In the world of biotech, Crispr gene editing technology is gaining increasing importance. Many companies in this field are led by former students of the pioneering scientists in the Crispr field. This shows the significant impact and potential of this technology.After a slow summer, there has been an uptick in biotech M&A activity. One notable acquisition is that of Orchard Therapeutics. This indicates the growing interest and investment in the biotech industry.In regulatory news, Pepgen has received clearance from the FDA to begin a study of its muscular dystrophy drug. This is an important milestone for the company, and we can expect to see the first results of this study next year.On the other hand, Alnylam has faced a setback as the FDA denied expanded approval for its RNA drug for a rare heart condition. This decision has set back the company's plans, highlighting the challenges faced by pharmaceutical companies in gaining regulatory approval for their products.Moving on to other news, Alvotech, a biopharmaceutical company, has received another rejection from the FDA for its biosimilar of Stelara. The FDA cited "deficiencies" at Alvotech's manufacturing plant as the reason for the rejection. This marks the fourth FDA rejection for Alvotech since last year.In a recent acquisition, Biogen has announced layoffs at Reata Pharmaceuticals, which it acquired for $7 billion. These layoffs will impact approximately one-third of Reata's workforce.In regulatory news, the European Commission has ordered Illumina to divest its subsidiary Grail. This decision comes after years of regulatory challenges and investigations.In clinical trial updates, Eli Lilly's mirikizumab has shown promising results in a Phase III trial for Crohn's disease. Over 54% of patients treated with mirikizumab achieved clinical remission at 52 weeks. Eli Lilly plans to submit a marketing application for mirikizumab in Crohn's disease to the FDA in 2024.Overall, these developments highlight the challenges faced by pharmaceutical companies in gaining regulatory approval for their products and the impact of acquisitions on workforce restructuring.The recent rejection by the FDA of a label expansion for Alnylam Pharmaceuticals' drug Onpattro to treat a rare heart condition has caused disappointment for the company. However, CEO Yvonne Greenstreet has outlined the company's future plans.This rejection sheds light on the challenges faced by drugmakers in gaining approval for their treatments. There is a delicate balance between patients and drugmakers wanting more liberal approval processes, while the medical community aims to ensure that drugs provide significant benefits compared to the risks.The FDA has been working towards bridging this gap through programs like Accelerating Rare Disease Cures (ARC). ARC aims to provide education campaigns and resources for developers to ensure all stakeholders are aligned.Alnylam's rejection serves as a reminder that surprises can still arise in the drug development and regulatory arenas. It also highlights the need for continuous innovation and adaptation in this field.Looking ahead, gene editing technology, particularly CRISPR-based therapies, holds great promise and could soon receive US approval. Many startups and scientists are actively working on advancements in this gene editing revolution.In summary, Alnylam's disap

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Biomarin's next chapter; Amgen's obesity plans; Daiichi's new ADC data; Acelyrin hit by clinical failure; and Skyrizi beats Stelara in Crohn's. https://scrip.citeline.com/SC149072/Quick-Listen-Scrips-Five-MustKnow-Things

The federal government announced it has selected the first 10 drugs it will negotiate for lower prices with pharmaceutical firms. The Centers for Medicare and Medicaid Services selected the drugs, all of which are covered under Medicare Part D. The 10 drugs — Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara and Fiasp/NovoLog — accounted for .5 billion of total costs for Medicare's Part D program from June 2022 to May 2023. Medicare plans to use the cost savings to place a ,000 limit on enrollees' of out-of-pocket expenditures for drugs starting in 2026. But it could delay innovation...Article Link

The FDA and CDC greenlight updated COVID-19; prescription drug for dry eye disease now available; head-to-head study comparing Skyrizi to Stelara for Crohn disease; the REMS program has been updated for IBS treatment Lotronex; and the FDA cracks down on companies selling unnaproved eye products.

Mark Twain once said, “Never put off till tomorrow, what you can do the day after tomorrow.” As an antidote to that Ralph welcomes Professor Piers Steel, author of “The Procrastination Equation: How to Stop Putting Things Off and Start Getting Stuff Done.” Plus, Ralph urges listeners to sign up for The Capitol Hill Citizen Association, another way to organize citizens to put pressure on the branch of our government where things must get done, the United States Congress.  Dr. Piers Steel is one of the world's leading researchers and speakers on the science of motivation and procrastination. Dr. Steel is a professor in the Organizational Behaviour and Human Resources area at the University of Calgary, and is the Brookfield Research Chair at the Haskayne School of Business. He is the author of The Procrastination Equation: How to Stop Putting Things Off and Start Getting Stuff Done.The root of procrastination is impulsiveness. Impulsiveness is valuing the now more than the later… We're designed to value the now. And this was really adaptive for a long time. It's not a bad trait. It's just that we've designed a world to take advantage of every little flaw that we have in our decision-making system.Dr. Piers SteelYou have to deal with yourself as an imperfect, flawed creature and deal with the reality of that. We're not robotic angels of perfection. We have limitations. And when I actually act within my limitations, I get stuff done.Dr. Piers SteelWe're superstars of self-control in the animal kingdom. We're able to hunt and kill most anything because we're willing to actually put in the delay of gratification. That's really what makes us great. But we're still not ready for things that are happening even a year off, much less five or ten.Dr. Piers SteelMore people will listen to what we just said about becoming part of the Capitol Hill Citizen Association and say to themselves, “I'm going to get around to doing that,” than the actual number of people who do it in a prompt period of time. So it would be very good to listen to Professor Steel's suggestions and read his book, because we cannot afford procrastinatory citizens. We have a procrastinatory Congress, and the citizens have got to get them to anticipate, to foresee, to forestall so many of the omnicidal urgencies that are coming at our country and other countries around the world.Ralph NaderTo become a member of the Capitol Hill Citizen Association, click here.In Case You Haven't Heard with Francesco DeSantis1. On August 28th, 20 groups – ranging from Left-wing anti-war organizations like Veterans for Peace to Right-leaning government transparency groups like R Street Institute – sent a letter to the Chairs and Ranking Members of the House and Senate Armed Services Committees demanding they maintain Rep. Jamaal Bowman's Cost of War amendment in the final National Defense Authorization Act. This provision “requires public disclosure about the cost of the U.S.' overseas military footprint and gives the American people greater transparency on military spending.” Hopefully, the left-right consensus on this issue is enough to maintain this amendment.2. In other Pentagon news, the Intercept reports that Rep. Matt Gaetz, Republican of Florida, has introduced an amendment demanding the Pentagon “collect information on trainees who overthrow their governments,” following the recent spate of coups in Africa. Gaetz told the Intercept “The Department of Defense, up until this point, has not kept data regarding the people they train who participate in coups to overthrow democratically elected — or any — governments.” This could become a flashpoint as Congress prepares to consider the 2024 NDAA when it returns from recess in September.3. As expected, tensions are running high in Guatemala following the upset victory of anti-corruption crusader Bernardo Arevalo. Opponents of Arevalo had urged the country's electoral tribunal to suspend his Semilla party on dubious legal grounds, which the tribunal resisted hewing to the letter of the law which dictated such actions could not be taken during the electoral process. After the election however, the party was officially suspended. Now, Reuters reports that suspension has been revoked, following a mass mobilization of Arevalo supporters in Guatemala City. It seems unlikely however that Arevalo's political opponents will accept his victory without a fight.4. In a dangerous, anti-free speech move, the Attorney General of Georgia has filed RICO indictments against 42 individuals involved with the Stop Cop City protest movement, the Atlanta Community Press Collective reports. This is the latest in a long line of attempts to quash opposition to the project, which has so far included trumped up domestic terrorism charges and arrests for handing out flyers.  5. Bloomberg reports that President Biden and Brazilian President Lula will jointly call for new worker protections at the upcoming General Assembly of the United Nations. While the article notes the two leaders have been “at odds” over China and Russia, they align on the topic of labor unionization. The two presidents have found common ground before, such as on the issue of climate change.6. Visual Effects workers at Disney have filed for unionization, per the Hollywood Reporter. Approximately 80% of VFX staff have already signed union cards, demanding an NLRB election and representation by the International Alliance of Theatrical Stage Employees or IATSE. This comes on the heels of a similar announcement by VFX workers at Marvel, a Disney subsidiary. In recent years. studios have increasingly relied on VFX workers in a rather blatant attempt to cut costs, as VFX workers have generally been non-union.7. At long last, the Department of Health and Human Services has announced the first ten drugs that will be subject to Mecicare negotiations to bring down prices. These are: Eliquis, Jardiance, Xarelto, Januvia Farxiga, Entresto, Enbrel, Imbruvica, Stelara and – crucially – several brands of insulin. HHS noted that “These selected drugs accounted for $50.5 billion in total [Medicare] Part D gross covered prescription drug costs, or about 20%, of total Part D gross between June 1, 2022 and May 31, 2023.”8. The Washington Post reports Acting Labor Secretary Julie Su has proposed new overtime rules intended to “extend overtime pay to an additional 3.6 million salaried white-collar workers in the United States.” According to current rules, workers are exempt from overtime if they make over $35,568 per year; the new rules would extend to workers making under $55,000 annually. If implemented, this would mean a whole new class of workers would be eligible for time-and-a-half pay if they work more than 40 hours per week.9. Per Republic Report: “The U.S. Department of Education announced…that it is cancelling $72 million in student loan obligations for more than 2,300 former students who attended for-profit Ashford University between 2009 and 2020.” Yet, even now the shady operators behind Ashford may still be able to squeeze money out of the taxpayers via a convoluted buyout by the University of Arizona Global Campus. Still, this marks a significant victory in a legal battle that has raged for over a decade, with Senator Tom Harkin of Iowa calling Ashford a “complete scam” all the way back in 2011.10. Finally, in more debt related news, the Philadelphia Inquirer has published a piece detailing how the nonprofit RIP Medical Debt was able to purchase – and forgive – over $1.6 million in medical debt. As the piece explains “When hospitals or physician groups have delinquent debts they have little chance of collecting on, they'll typically go to what's called the secondary market and sell their portfolios for pennies on the dollar.” It was on this secondary market that RIP Medical Debt was able to buy $1.6 million worth of debt for just $17,000. In celebration, “30 proud, self-described gutter-pagan, mostly queer dirtbags in their early 30s,” gathered for a ritual burning of an oversized medical bill. Someone chanted “debt is hell” and the crowd responded “let it burn.” Get full access to Ralph Nader Radio Hour at www.ralphnaderradiohour.com/subscribe

Politisches Risiko und hoch im Kurs Wer meine Podcasts Börsenminute und GELDMEISTERIN schon länger verfolgt, weiß, dass ich Pharmaaktien für mein Langfristportfolio als eine wichtige Säule favorisiere und das tue ich auch weiterhin. Nur: durch die letzten starken Anstiege vor allem beim skandinavischen Shootingstar Novo Nordisk (Stichwort Diabetesmedikamente, die als Abnehmpille Furore machen) bin ich dabei, mein Pharma-Portfolio zu Rebalancieren, sprich einen Teil der Kursraketen zu verkaufen, um den Gesundheitstitel-Anteil und so mein Klumpenrisiko wieder zu reduzieren. Oder mir maximal die jüngsten Rohrkrepierer wie Roche zumindest genauer anzuschauen. Denn Risiko-behaftet sind Gesundheitstitel in jedem Fall und da denke ich nicht einmal an etwaige Nebenwirkungen, die in der Vergangenheit schon des Öfteren zu sündteuren Klagen geführt haben. Nein, es sind die Bewertungen, die ich teilweise nicht mehr gesund finde. Eli Lilly zum Beispiel hat in den letzten fünf Jahren um 430 Prozent zugelegt. Das Kurs-Gewinn-Verhältnis liegt bei knapp 56. Soll heißen, ich muss - aus heutiger Sicht wohlgemerkt - 56 Jahre warten, bis ich den Preis für die Aktie hereinverdient habe. Das dauert mir zu lange, auch wenn ich ihnen viel Gewinnsteigerungspotenzial noch zutraue. Man sollte keinesfalls das politische Risiko der Branche unterschätzen. Joe Biden hat gerade zehn Medikamente auf seiner Watchlist, die seinen „Inflation Reduction Act“ konterkarieren. Hier wird gerade mit Bristol-Myers, Johnson & Johnsohn, Merck, Novo Nordisk, Boehringer Ingelheim, Novartis, Amgen & Co gefeilscht, welche Preise das staatliche Gesundheitssystem künftig nur noch für die Arznei bereit ist zu bezahlen und das ist nicht unerheblich. Zum einen, schreibt die Financial Times, droht ihnen eine Besteuerung von 65 bis 95 Prozent, zum anderen ein Ausschluss aus dem Gesundheitsprogramm Medicare, was tragisch wäre, da es teilweise zu 50 Prozent ihre Umsätze in den USA sichert. Die konkreten Medikamente, deren Preise für Biden´s Geschmack zu hoch sind, findet ihr hier im Beipackzettel zu dieser Börsenminute: • Eliquis von Bristol-Myers Squibb (NYSE:BMY); • Jardiance von Boehringer Ingelheim; • Xarelto von Johnson & Johnson (NYSE:JNJ); • Januvia von Merck (NYSE:MRK); • Farxiga von AstraZeneca (NASDAQ:AZN); • Entresto von Novartis (NYSE:NVS); • Enbrel von Amgen (NASDAQ:AMGN); • Imbruvica von AbbVie (NYSE:ABBV); • Stelara von Janssen (im Besitz von JNJ); • Fiasp, Fiasp FlexTouch, Fiasp PenFill, NovoLog, NovoLog FlexPen, NovoLog PenFill von Novo Nordisk (NYSE:NVO). Rechtshinweis: Dies ist die Meinunung der Autorin und keine Anlageempfehlung. Was ihr daraus macht ist Eure Sache, Julia Kistner übernimmt hierfür keine Haftung. #Börse #investment #Pharmatitel #Inflationreductionact #Aktien #podcast Foto: Unsplash

Florida Gov and GOP 2024 also-ran Ron DeSantis looks to lead in wake of violence and major hurricane | Former SC Gov and UN Ambassador under President Trump, Nikki Haley is having a moment, kind of | President Biden names first 10 drugs subject to negotations with Medicare | 60th anniversary of the March on WashingtonSong playsIntro by hostWelcome to Heartland Pod Wednesday!Support this show and all the work in the Heartland POD universe by going to heartlandpod.com and clicking the link for Patreon, or go to Patreon.com/HeartlandPod to sign up. Membership starts at $1/month, with even more extra shows and special access at the higher levels. No matter the level you choose, your membership helps us create these independent shows as we work together to change the conversation.Alright! Let's get into it: Hurricane in Florida / Shooting in FloridaPOLITICO: DeSantis knows how to handle a hurricane. The racist shooting poses a bigger dilemma.A racially-motivated Jacksonville tragedy, couple with a looming storm, pose big tests for the governor.Florida Gov. Ron DeSantis, center and his wife Casey, right, bow their heads during a prayer.Florida Gov. Ron DeSantis (center) and his wife Casey bow their heads during a prayer at a vigil for the victims of Saturday's mass shooting on Sunday, Aug. 27, 2023, in Jacksonville. | John Raoux/AP PhotoBy KIMBERLY LEONARD08/28/2023 04:14 PM EDTUpdated: 08/28/2023 05:12 PM EDTMIAMI — Florida Gov. Ron DeSantis' handling of back-to-back crises — a racist mass shooting and a potentially catastrophic hurricane — could help burnish his image as a can-do, effective governor or further damage his standing with Black Americans who have grown livid over his policies.Already, DeSantis' attempts to show leadership in the immediate aftermath of the Saturday shooting were poorly received by some Black lawmakers, Democrats and residents in Florida. In the hours after a 21-year-old white man killed three Black Floridians near a historically Black college in Jacksonville, several state Democrats blamed DeSantis, who is running for president, for creating an environment, through policies such as loosening gun laws and ending diversity programs, that helped hate fester.DeSantis has condemned the shooting and said “targeting people due to their race has no place in this state of Florida.” But attending a Sunday night vigil in Jacksonville, he was jeered and booed by people who had come out to remember the victims. At one point, a Jacksonville Democratic councilmember stepped in to calm the crowd, urging people to “put parties aside.” Later during the event, a pastor took issue with DeSantis describing the gunman as a “scumbag,” and said he should have used the word “racist” instead.The vigil stood in contrast to press conferences in Tallahassee on Sunday and Monday, when DeSantis appeared visibly tired but spoke authoritatively about preparations overseeing Tropical Storm Idalia, which is forecast to become a major hurricane. He canceled campaign appearances and fundraisers, and told Floridians Sunday they could “rest assured” because “I am here” and would “get the job done.”DeSantis says politics won't interfere with storm response“He needs to be in Florida for as long as it takes,” said Adam Hollingsworth, the former chief of staff to Sen. Rick Scott (R-Fla.), who served as governor before DeSantis. “His presidential ambitions could be a distraction, but first Gov. DeSantis has to dance with the one who brought him. Right now, that's the people of Florida.”Though the shooting and looming storm are taking DeSantis away from campaigning for president following a high-profile debate, they'll also allow voters and donors to see the governor at work leading the hurricane response, letting the public assess how he balances multiple priorities, displays empathy and projects leadership in moments of tragedy. At the same time, the shooting has shined a spotlight on DeSantis' record and vulnerabilities on race, one of the areas for which he has faced the most criticism and controversy as governor.In times of tragedy, opponents are “looking for a misstep,” acknowledged Craig Fugate, who led Florida's emergency division under Gov. Jeb Bush and oversaw FEMA during the Obama administration.“They're looking for something to go wrong — particularly for the opponents; they're looking for something to capitalize on,” Fugate said.DeSantis began his Monday morning hurricane preparedness press conference by first addressing the mass shooting. He pledged $1 million in security funding to Edward Waters University, a historically Black university that the gunman is believed to have initially targeted, as well as $100,000 toward a charity for the families of the victims. He also deployed state law enforcement officials to evaluate the campus' security and make additional recommendations, pledging to continue to assist in the “days and weeks ahead.”But many Democrats in the state panned his response. They pointed to laws he enacted in Florida to carve up representation in a Black-majority district that eventually led a Black Democratic congressman, Rep. Al Lawson, to lose his seat. They also pointed to his policies, approved by the GOP-led Legislature, banning what he calls “critical race theory” in schools, as well as his defense of a public school curriculum on Black history that required middle-school teachers to instruct that enslaved people “developed skills which, in some instances, could be applied for their personal benefit.”Florida Minority House Leader Fentrice Driskell, a Black Democrat of Tampa, said it was “absolutely” the right decision for DeSantis to attend the vigil but added that she didn't want to give him a pass.“The reality is, a number of wrongheaded decisions about the state of Florida, and who we are as a people, I think contributed to this charged political climate that resulted in the violence that we saw,” Driskell said in an interview.The accused gunman, identified as Ryan Palmeter, had a racist manifesto and drew swastikas on his weapons. He also had a history of mental illness, having been involuntarily institutionalized for emergency mental health services as a teenager, police said.During DeSantis' vigil remarks Sunday, Democratic state Rep. Angela Nixon, who represents the district where the shooting took place, could be seen glaring at the governor in videos and photos widely shared on social media.“We feel the same,” the NAACP wrote on X, the social media platform formerly known as Twitter.AXIOS: Biden set to name first 10 drugs subject to Medicare negotiations.The blood-thinners Eliquis and Xarelto are among the 10 prescription medicines the Biden administration will seek lower Medicare prices for as part of a new program allowing the government to negotiate drug prices for America's seniors.Why it matters: The administration's landmark announcement Tuesday detailed the first-ever set of drugs subject to Medicare price negotiations, a longtime Democratic priority included in last year's Inflation Reduction Act over drug companies' fervent objections.Other drugs up for negotiation include:Jardiance, a diabetes drug.Januvia, also for diabetes.Farxiga, another diabetes drug.Entresto, for heart failure.Enbrel, for arthritis and psoriasis.Imbruvica, a blood cancer drug.Stelara, used on psoriasis, Crohn's disease and other illnesses.Fiasp, also used for diabetes.Of note: Insulin is already subject to a $35 monthly co-pay cap for Medicare prescription drug plan enrollees under a different provision of the IRA.State of play: The drugs' manufacturers will have just over a month to decide whether to participate in negotiations — which the industry is battling in court — or sit out the process, at the risk of significant financial penalty.Drugmakers who refuse to negotiate with Medicare face an excise tax of up to 95% of their U.S. sales, or they can withdraw their drugs from Medicare and Medicaid coverage, shutting them out of huge markets.What they're saying: "The cancer moonshot will not succeed if this administration continues to dismantle the innovation rocket we need to get there," Stephen Ubl, CEO of industry trade group PhRMA, said in a statement following the release of the list.Zoom out: The medicines up for negotiation were chosen from a list of the 50 products with the highest spending in Medicare's prescription drug program, Part D.The selected drugs accounted for 20% of Part D prescription costs between June 1, 2022 and May 31, 2023, according to the Health and Human Services Department.Some of the highest-cost Medicare drugs were not eligible for this round of negotiations, either because they still have market exclusivity, they're the only option for a rare disease or another factor.The prices won't take effect before the 2024 elections, but Democrats are expected to tout the negotiations, along with other drug cost reforms in the IRA, as part of their campaign messaging.What's next: The Centers for Medicare and Medicaid Services will submit price offers to the drug companies by Feb. 1, with negotiations continuing until next August.CMS will publish the drugs' final maximum fair prices by Sept. 1, 2024, and prices will go into effect in 2026.What we're watching: Ongoing legal challenges could draw out or halt the negotiation process.Drugmakers and allied groups have already filed eight lawsuits against the Medicare drug negotiation process, and more lawsuits could follow Tuesday's announcement.President Biden and his health officials committed this morning to fighting industry lawsuits."Let me be clear: I am not backing down. There is no reason why Americans should be forced to pay more than any developed nation for life-saving prescriptions just to pad Big Pharma's pockets," Biden said in a statement.Nikki HaleyDAILY BEAST: Is it time for Republicans to take Nikki Haley seriously?According to a new Emerson College Polling survey, “Haley saw the largest increase in support among Republican candidates, jumping 5 points from 2 percent to 7 percent” following last week's debate.“Nikki Haley's support increased from about 2 percent to 9 percent among voters over 50 [years of age],” said Spencer Kimball, executive director of Emerson College Polling, “while Trump's support dropped within this age group from about 56 percent to 49 percent after the debate.”Republican Debaters Agreed on One Thing: They Hate Vivek RamaswamyThis jump is modest, inasmuch as it still leaves Haley in the single digits. But it's also no outlier. According to a poll conducted by The Washington Post, FiveThirtyEight, and Ipsos released last Thursday, voters were persuaded to at least give her a second look. “Pre-debate, 29 percent of GOP primary voters who watched the debate said they were considering voting for her,” according to the survey, “and that increased to 46 percent after the debate.”So how did she do it? Haley caught our attention by being first to hit Trump (from the right), when she criticized him for “adding eight trillion to our debt.” This surprised everyone, demonstrated courage, and put to rest the notion that she is merely running to be Trump's vice president.Haley also staked out a strong position on abortion. While stressing her pro-life beliefs, she made the pragmatic case that a federal abortion ban would require 60 votes. Instead, Haley urged Republicans to focus on consensus issues, like banning late-term abortions, making sure contraception is widely available, and supporting adoption as an alternative.Trump's former veep, Mike Pence, who supports a 15-week federal ban on abortion, took umbrage with this. “Nikki, you're my friend, but consensus is the opposite of leadership,” Pence scolded. (As the Never Trump conservative writer Jonah Goldberg has pointed out on his podcast, building consensus is often a key attribute of leadership.)The Republican Debate Was a Futile Pudding Wrestling MatchThis exchange, like others during that same debate, made it clear that in a general election Nikki Haley would likely be Joe Biden's most challenging opponent.Having served as governor of South Carolina and ambassador to the United Nations, she has the experience needed for the office. She also has sharp elbows. (“You have no foreign policy experience and it shows,” she told Vivek Ramaswamy.)At 51, Haley would present a stark contrast in terms of generational change, assuming that Joe Biden was still the Democratic nominee. And (unlike others) she is not staking out an abortion position that might render her effectively unelectable, should she become the Republican nominee.Haley (who frequently cites Margaret Thatcher's line, “If you want something said, ask a man. If you want something done, ask a woman”) was the only woman on that stage. Her identity, temperament, and policy positions could help chip away at the gender gap that has only grown in recent years.The obvious caveat here is that all of these things would make Haley a great candidate to beat Joe Biden if she somehow wins the Republican nomination. But that's an awfully big “if.”Kareem Abdul-Jabbar: GOP Debate Showed How Not to Pick a PresidentHaley's answer to this is to make the electability argument: “We have to face the fact that Trump is the most disliked politician in America,” she—and she, alone—averred during last week's debate.But will that dog hunt?Right now, the electability argument isn't persuading Republicans to jump off the Trump bandwagon, even though that argument is likely the only one that could ever work. At some point (perhaps after Donald Trump goes on trial and it's too late), Republicans might be convinced that, as entertaining as Trump is, he simply can't win.Based on all of this, you might expect me to suggest that it's time to clear the field—to rally every freedom conservative, Reagan Republican, and Never Trump conservative to coalesce around Haley as the GOP's last, best hope.Some of my colleagues are already there. The New York Times columnist David Brooks, for example, declared last week that “Wednesday's debate persuaded me that the best Trump alternative is not [Tim] Scott, it's Nikki Haley.”But here's my problem. Haley has been all over the map for years now. One day she's courageous and impressive, and the next day she's a pathetic Trump toady.Haley is a political chameleon, which makes me reluctant to ever trust her again.Trump and Ramaswamy Show Us How the Worst Get to the TopOn the other hand, anyone looking for purity (as it pertains to Trump) can also dismiss Pence and Chris Christie—both of whom supported Trump until Jan. 6—and a vast swath of today's leading Never Trumpers. As the Good Book says, “Who then can be saved?”Nikki Haley's got a long way to go before she clears the not-Trump lane of candidates, much less taking on the final boss himself. And though nothing has yet made a dent in Trump's domination of the GOP voter base, he's never run as a candidate on trial before. But the whole 91-felony indictment thing might just do the trick.If Haley can prove herself by stringing together two or three of these kinds of courageous performances—in which she not only characterizes Trump as the guy who already lost to Biden, but also that she's as real a conservative as any of the other contenders—there is a path to success.It's hardly guaranteed, and as I've noted, courage comes and goes with Haley. But in the “Matt Lewis primary,” you can count me among the 46 percent who are now considering voting for her.Read more at The Daily Beast.SEMAFOR: Nikki Haley's abortion message could catch on in the GOPMorgan Chalfant and Kadia GobaRepublicans worried about Democrats leveraging abortion (again) to make gains in 2024 want GOP candidates to take a page out of Nikki Haley's debate prep playbook.Haley dismissed the idea that a 15-week national abortion ban could pass through Congress. Instead, she argued the focus should be on finding “consensus” around banning “late-term abortions,” sustaining access to contraception, allowing doctors who don't support abortion refuse to perform them, and preventing women who get abortions from being penalized.Defeated Michigan gubernatorial candidate Tudor Dixon bluntly said on Fox News that Republicans would lose the messaging war in 2024 unless they followed Haley's “perfect response” in the debate.“No one really understood how important abortion would be in 2022 because no one had run in a post-Roe world, so we suddenly got attacked, viciously attacked, by the Democrats, and it is a winning message for them,” she said. Gov. Gretchen Whitmer highlighted Dixon's opposition to rape exceptions in abortion bans in their contest, which took place alongide a ballot initiative guaranteeing abortion rights that passed by a wide margin.“The only candidate on the stage that talked about how we should protect women and not demonize them was Nikki Haley,” Rep. Nancy Mace, R-S.C. said Sunday on CBS of the first GOP presidential debate. “And that is a message that we have to carry through. We have to be pro-woman and pro-life. You cannot go after women and attack them because they make a choice that you don't like or don't agree with.”And Rep. George Santos, R-N.Y., who represents a district President Biden won in 2020, told Semafor at a watch party last week: “She had probably the best-packaged message on abortion that I've heard, I want to say, in my entire adult life.”Haley might have won herself some fans, but her position wasn't a favorite within the anti-abortion movement, which has rallied around a 15-week federal ban as a minimum ask for candidates.

Florida Gov and GOP 2024 also-ran Ron DeSantis looks to lead in wake of violence and major hurricane | Former SC Gov and UN Ambassador under President Trump, Nikki Haley is having a moment, kind of | President Biden names first 10 drugs subject to negotations with Medicare | 60th anniversary of the March on WashingtonSong playsIntro by hostWelcome to Heartland Pod Wednesday!Support this show and all the work in the Heartland POD universe by going to heartlandpod.com and clicking the link for Patreon, or go to Patreon.com/HeartlandPod to sign up. Membership starts at $1/month, with even more extra shows and special access at the higher levels. No matter the level you choose, your membership helps us create these independent shows as we work together to change the conversation.Alright! Let's get into it: Hurricane in Florida / Shooting in FloridaPOLITICO: DeSantis knows how to handle a hurricane. The racist shooting poses a bigger dilemma.A racially-motivated Jacksonville tragedy, couple with a looming storm, pose big tests for the governor.Florida Gov. Ron DeSantis, center and his wife Casey, right, bow their heads during a prayer.Florida Gov. Ron DeSantis (center) and his wife Casey bow their heads during a prayer at a vigil for the victims of Saturday's mass shooting on Sunday, Aug. 27, 2023, in Jacksonville. | John Raoux/AP PhotoBy KIMBERLY LEONARD08/28/2023 04:14 PM EDTUpdated: 08/28/2023 05:12 PM EDTMIAMI — Florida Gov. Ron DeSantis' handling of back-to-back crises — a racist mass shooting and a potentially catastrophic hurricane — could help burnish his image as a can-do, effective governor or further damage his standing with Black Americans who have grown livid over his policies.Already, DeSantis' attempts to show leadership in the immediate aftermath of the Saturday shooting were poorly received by some Black lawmakers, Democrats and residents in Florida. In the hours after a 21-year-old white man killed three Black Floridians near a historically Black college in Jacksonville, several state Democrats blamed DeSantis, who is running for president, for creating an environment, through policies such as loosening gun laws and ending diversity programs, that helped hate fester.DeSantis has condemned the shooting and said “targeting people due to their race has no place in this state of Florida.” But attending a Sunday night vigil in Jacksonville, he was jeered and booed by people who had come out to remember the victims. At one point, a Jacksonville Democratic councilmember stepped in to calm the crowd, urging people to “put parties aside.” Later during the event, a pastor took issue with DeSantis describing the gunman as a “scumbag,” and said he should have used the word “racist” instead.The vigil stood in contrast to press conferences in Tallahassee on Sunday and Monday, when DeSantis appeared visibly tired but spoke authoritatively about preparations overseeing Tropical Storm Idalia, which is forecast to become a major hurricane. He canceled campaign appearances and fundraisers, and told Floridians Sunday they could “rest assured” because “I am here” and would “get the job done.”DeSantis says politics won't interfere with storm response“He needs to be in Florida for as long as it takes,” said Adam Hollingsworth, the former chief of staff to Sen. Rick Scott (R-Fla.), who served as governor before DeSantis. “His presidential ambitions could be a distraction, but first Gov. DeSantis has to dance with the one who brought him. Right now, that's the people of Florida.”Though the shooting and looming storm are taking DeSantis away from campaigning for president following a high-profile debate, they'll also allow voters and donors to see the governor at work leading the hurricane response, letting the public assess how he balances multiple priorities, displays empathy and projects leadership in moments of tragedy. At the same time, the shooting has shined a spotlight on DeSantis' record and vulnerabilities on race, one of the areas for which he has faced the most criticism and controversy as governor.In times of tragedy, opponents are “looking for a misstep,” acknowledged Craig Fugate, who led Florida's emergency division under Gov. Jeb Bush and oversaw FEMA during the Obama administration.“They're looking for something to go wrong — particularly for the opponents; they're looking for something to capitalize on,” Fugate said.DeSantis began his Monday morning hurricane preparedness press conference by first addressing the mass shooting. He pledged $1 million in security funding to Edward Waters University, a historically Black university that the gunman is believed to have initially targeted, as well as $100,000 toward a charity for the families of the victims. He also deployed state law enforcement officials to evaluate the campus' security and make additional recommendations, pledging to continue to assist in the “days and weeks ahead.”But many Democrats in the state panned his response. They pointed to laws he enacted in Florida to carve up representation in a Black-majority district that eventually led a Black Democratic congressman, Rep. Al Lawson, to lose his seat. They also pointed to his policies, approved by the GOP-led Legislature, banning what he calls “critical race theory” in schools, as well as his defense of a public school curriculum on Black history that required middle-school teachers to instruct that enslaved people “developed skills which, in some instances, could be applied for their personal benefit.”Florida Minority House Leader Fentrice Driskell, a Black Democrat of Tampa, said it was “absolutely” the right decision for DeSantis to attend the vigil but added that she didn't want to give him a pass.“The reality is, a number of wrongheaded decisions about the state of Florida, and who we are as a people, I think contributed to this charged political climate that resulted in the violence that we saw,” Driskell said in an interview.The accused gunman, identified as Ryan Palmeter, had a racist manifesto and drew swastikas on his weapons. He also had a history of mental illness, having been involuntarily institutionalized for emergency mental health services as a teenager, police said.During DeSantis' vigil remarks Sunday, Democratic state Rep. Angela Nixon, who represents the district where the shooting took place, could be seen glaring at the governor in videos and photos widely shared on social media.“We feel the same,” the NAACP wrote on X, the social media platform formerly known as Twitter.AXIOS: Biden set to name first 10 drugs subject to Medicare negotiations.The blood-thinners Eliquis and Xarelto are among the 10 prescription medicines the Biden administration will seek lower Medicare prices for as part of a new program allowing the government to negotiate drug prices for America's seniors.Why it matters: The administration's landmark announcement Tuesday detailed the first-ever set of drugs subject to Medicare price negotiations, a longtime Democratic priority included in last year's Inflation Reduction Act over drug companies' fervent objections.Other drugs up for negotiation include:Jardiance, a diabetes drug.Januvia, also for diabetes.Farxiga, another diabetes drug.Entresto, for heart failure.Enbrel, for arthritis and psoriasis.Imbruvica, a blood cancer drug.Stelara, used on psoriasis, Crohn's disease and other illnesses.Fiasp, also used for diabetes.Of note: Insulin is already subject to a $35 monthly co-pay cap for Medicare prescription drug plan enrollees under a different provision of the IRA.State of play: The drugs' manufacturers will have just over a month to decide whether to participate in negotiations — which the industry is battling in court — or sit out the process, at the risk of significant financial penalty.Drugmakers who refuse to negotiate with Medicare face an excise tax of up to 95% of their U.S. sales, or they can withdraw their drugs from Medicare and Medicaid coverage, shutting them out of huge markets.What they're saying: "The cancer moonshot will not succeed if this administration continues to dismantle the innovation rocket we need to get there," Stephen Ubl, CEO of industry trade group PhRMA, said in a statement following the release of the list.Zoom out: The medicines up for negotiation were chosen from a list of the 50 products with the highest spending in Medicare's prescription drug program, Part D.The selected drugs accounted for 20% of Part D prescription costs between June 1, 2022 and May 31, 2023, according to the Health and Human Services Department.Some of the highest-cost Medicare drugs were not eligible for this round of negotiations, either because they still have market exclusivity, they're the only option for a rare disease or another factor.The prices won't take effect before the 2024 elections, but Democrats are expected to tout the negotiations, along with other drug cost reforms in the IRA, as part of their campaign messaging.What's next: The Centers for Medicare and Medicaid Services will submit price offers to the drug companies by Feb. 1, with negotiations continuing until next August.CMS will publish the drugs' final maximum fair prices by Sept. 1, 2024, and prices will go into effect in 2026.What we're watching: Ongoing legal challenges could draw out or halt the negotiation process.Drugmakers and allied groups have already filed eight lawsuits against the Medicare drug negotiation process, and more lawsuits could follow Tuesday's announcement.President Biden and his health officials committed this morning to fighting industry lawsuits."Let me be clear: I am not backing down. There is no reason why Americans should be forced to pay more than any developed nation for life-saving prescriptions just to pad Big Pharma's pockets," Biden said in a statement.Nikki HaleyDAILY BEAST: Is it time for Republicans to take Nikki Haley seriously?According to a new Emerson College Polling survey, “Haley saw the largest increase in support among Republican candidates, jumping 5 points from 2 percent to 7 percent” following last week's debate.“Nikki Haley's support increased from about 2 percent to 9 percent among voters over 50 [years of age],” said Spencer Kimball, executive director of Emerson College Polling, “while Trump's support dropped within this age group from about 56 percent to 49 percent after the debate.”Republican Debaters Agreed on One Thing: They Hate Vivek RamaswamyThis jump is modest, inasmuch as it still leaves Haley in the single digits. But it's also no outlier. According to a poll conducted by The Washington Post, FiveThirtyEight, and Ipsos released last Thursday, voters were persuaded to at least give her a second look. “Pre-debate, 29 percent of GOP primary voters who watched the debate said they were considering voting for her,” according to the survey, “and that increased to 46 percent after the debate.”So how did she do it? Haley caught our attention by being first to hit Trump (from the right), when she criticized him for “adding eight trillion to our debt.” This surprised everyone, demonstrated courage, and put to rest the notion that she is merely running to be Trump's vice president.Haley also staked out a strong position on abortion. While stressing her pro-life beliefs, she made the pragmatic case that a federal abortion ban would require 60 votes. Instead, Haley urged Republicans to focus on consensus issues, like banning late-term abortions, making sure contraception is widely available, and supporting adoption as an alternative.Trump's former veep, Mike Pence, who supports a 15-week federal ban on abortion, took umbrage with this. “Nikki, you're my friend, but consensus is the opposite of leadership,” Pence scolded. (As the Never Trump conservative writer Jonah Goldberg has pointed out on his podcast, building consensus is often a key attribute of leadership.)The Republican Debate Was a Futile Pudding Wrestling MatchThis exchange, like others during that same debate, made it clear that in a general election Nikki Haley would likely be Joe Biden's most challenging opponent.Having served as governor of South Carolina and ambassador to the United Nations, she has the experience needed for the office. She also has sharp elbows. (“You have no foreign policy experience and it shows,” she told Vivek Ramaswamy.)At 51, Haley would present a stark contrast in terms of generational change, assuming that Joe Biden was still the Democratic nominee. And (unlike others) she is not staking out an abortion position that might render her effectively unelectable, should she become the Republican nominee.Haley (who frequently cites Margaret Thatcher's line, “If you want something said, ask a man. If you want something done, ask a woman”) was the only woman on that stage. Her identity, temperament, and policy positions could help chip away at the gender gap that has only grown in recent years.The obvious caveat here is that all of these things would make Haley a great candidate to beat Joe Biden if she somehow wins the Republican nomination. But that's an awfully big “if.”Kareem Abdul-Jabbar: GOP Debate Showed How Not to Pick a PresidentHaley's answer to this is to make the electability argument: “We have to face the fact that Trump is the most disliked politician in America,” she—and she, alone—averred during last week's debate.But will that dog hunt?Right now, the electability argument isn't persuading Republicans to jump off the Trump bandwagon, even though that argument is likely the only one that could ever work. At some point (perhaps after Donald Trump goes on trial and it's too late), Republicans might be convinced that, as entertaining as Trump is, he simply can't win.Based on all of this, you might expect me to suggest that it's time to clear the field—to rally every freedom conservative, Reagan Republican, and Never Trump conservative to coalesce around Haley as the GOP's last, best hope.Some of my colleagues are already there. The New York Times columnist David Brooks, for example, declared last week that “Wednesday's debate persuaded me that the best Trump alternative is not [Tim] Scott, it's Nikki Haley.”But here's my problem. Haley has been all over the map for years now. One day she's courageous and impressive, and the next day she's a pathetic Trump toady.Haley is a political chameleon, which makes me reluctant to ever trust her again.Trump and Ramaswamy Show Us How the Worst Get to the TopOn the other hand, anyone looking for purity (as it pertains to Trump) can also dismiss Pence and Chris Christie—both of whom supported Trump until Jan. 6—and a vast swath of today's leading Never Trumpers. As the Good Book says, “Who then can be saved?”Nikki Haley's got a long way to go before she clears the not-Trump lane of candidates, much less taking on the final boss himself. And though nothing has yet made a dent in Trump's domination of the GOP voter base, he's never run as a candidate on trial before. But the whole 91-felony indictment thing might just do the trick.If Haley can prove herself by stringing together two or three of these kinds of courageous performances—in which she not only characterizes Trump as the guy who already lost to Biden, but also that she's as real a conservative as any of the other contenders—there is a path to success.It's hardly guaranteed, and as I've noted, courage comes and goes with Haley. But in the “Matt Lewis primary,” you can count me among the 46 percent who are now considering voting for her.Read more at The Daily Beast.SEMAFOR: Nikki Haley's abortion message could catch on in the GOPMorgan Chalfant and Kadia GobaRepublicans worried about Democrats leveraging abortion (again) to make gains in 2024 want GOP candidates to take a page out of Nikki Haley's debate prep playbook.Haley dismissed the idea that a 15-week national abortion ban could pass through Congress. Instead, she argued the focus should be on finding “consensus” around banning “late-term abortions,” sustaining access to contraception, allowing doctors who don't support abortion refuse to perform them, and preventing women who get abortions from being penalized.Defeated Michigan gubernatorial candidate Tudor Dixon bluntly said on Fox News that Republicans would lose the messaging war in 2024 unless they followed Haley's “perfect response” in the debate.“No one really understood how important abortion would be in 2022 because no one had run in a post-Roe world, so we suddenly got attacked, viciously attacked, by the Democrats, and it is a winning message for them,” she said. Gov. Gretchen Whitmer highlighted Dixon's opposition to rape exceptions in abortion bans in their contest, which took place alongide a ballot initiative guaranteeing abortion rights that passed by a wide margin.“The only candidate on the stage that talked about how we should protect women and not demonize them was Nikki Haley,” Rep. Nancy Mace, R-S.C. said Sunday on CBS of the first GOP presidential debate. “And that is a message that we have to carry through. We have to be pro-woman and pro-life. You cannot go after women and attack them because they make a choice that you don't like or don't agree with.”And Rep. George Santos, R-N.Y., who represents a district President Biden won in 2020, told Semafor at a watch party last week: “She had probably the best-packaged message on abortion that I've heard, I want to say, in my entire adult life.”Haley might have won herself some fans, but her position wasn't a favorite within the anti-abortion movement, which has rallied around a 15-week federal ban as a minimum ask for candidates.

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An Interview with Jeff Thomlinson I recorded last November, sharing my story about Ulcerative Colitis then going through life with an ostomy before I had the 2 step J pouch surgery. A few things I didn't mention in the podcast is that part of my healing is because of Stelara, a medication I resorted to take after trying many natural treaments. I continue to follow a sugar free diet with limited processed foods as well as see a naturopath which is helpful. I am grateful for the western drug to help as well. Email me to connect: Julianalavell17@gmail.com www.julianalavell.com

Michael Leis is an end-to-end marketer who has developed a portfolio of leadership experiences across healthcare, CPG, QSR, e-commerce, and software design. In each, his pride is in building dynamic teams designing record-breaking success for the world's largest, most complex brands. As Chief Content Strategy Officer at Publicis Health, Michael created and scaled the content marketing model across strategy, creative, production, systems, and distribution for 16 business units in the network. His blend of technology, media, behavior design and story structure has reoriented top healthcare brands to create stories worth sharing. Recently featured as having authored a global strategic best practice by WARC (2020) and Cannes Lions keynote presentation (2021), Michael architects teams to achieve unparalleled success, including the first-ever healthcare brand to win a platform-wide Shorty Award. Before joining Digitas Health, Michael led the creation and operation of the digital and social media practice at Draftfcb in Chicago. This included healthcare brands Stelara and Janssen's Positively Together HIV community. He also led brands across industries to new growth, including: Taco Bell, Sharpie, Cox Communications, KFC, Discover Financial, Tombstone Pizza, and Diners Club. Michael graduated Temple University with a degree in television screenwriting and production. He lives in the Philadelphia area with his wife, Jessica, and two sons, Jacob, and Maxwell. You'll find him at small venue music shows and sitting close enough at sports events that players can hear him.

Despite a bevy of biologics available for people struggling with Crohn's disease and ulcerative colitis (UC), not all patients are able to respond to or tolerate a vast majority of approved therapies. Fortunately, new data presented at Digestive Disease Week (DDW) 2022 suggests that ustekinumab (STELARA) could function as an alternative option to bio-failure and bio-naïve patients living with these inflammatory bowel diseases (IBD). Pooled data from four long-term phase 2 and 3 studies of bio-naïve IBD patients found that event rate per 100 patient-years for adverse events (AE), serious AEs, infection, malignancies, and more were similar and/or numerically lower for patients who received ustekinumab compared to those on placebo. Similar event rates were observed in five phase 2/3 IBD studies of bio-failure patients over a 5-year period. Additionally, new phase 2 data showed that participants treated with guselkumab who had inadequate responses to conventional therapies achieved high levels of clinical-biomarker response, endoscopic response, and clinical remission compared to those on placebo. For this episode of DocTalk, Assistant Managing Editor Kenny Walter spoke with  Remo Panaccione, MD, Director of the IBD Clinic and Director of Gastroenterology Research at the University of Calgary, of the implications of the new ustekinumab and guselkumab data on long-term IBD care. 

This episode was very hard for me (Natalie) to record. I'm going to be opening up with you and sharing one of my biggest struggles that I've been battling for years—Crohn's, but more specifically, weight gain on biologic medications. ----more---- Being Sick AND Successful (you know the premise of my whole company) means I share these moments with you no matter how hard.   In today's FIRST duo of a Youtube Video and Podcast (found on all platforms), I'm sharing about my experience with biologic medication and weight gain and how that affects my day-to-day life and business. ----more---- What does it mean to love and accept yourself no matter what? ----more---- In today's episode of The Sick & Successful Podcast, it's time to get honest about loving me and my body. I talk about my journey with Crohn's disease and various medications that caused side effects I had (and have) no control over. The extreme weight gain has caused mental health struggles that I still battle to this day, especially now that it's happening all over again. ----more---- Tune in and get to know more about my story with Humira and weight gain and now, most recently, Entyvio and weight gain. ----more---- Watch on YouTube: https://youtu.be/R6LjijK2V7g  ----more---- Loved this episode? Feel free to comment or share your experience and thoughts with Natalie through the DMs on Instagram (@for.the.success) or reach out through email at info@sandscreative.ca!    Stay connected with us through these links: www.sandscreative.ca www.instagram.com/s.and.s.creative www.instagram.com/for.the.success

This week on Pharm5: Oral tebipenem noninferior to IV ertapenem for complicated UTIs Stelara's potential biosimilar ustekinumab ABP 654's promising results SODIUM-HF trial finds no benefit to extreme sodium restriction in heart failure InspectIR COVID-19 Breathalyzer receives EUA Avastin's third biosimilar bevacizumab-maly (Almsys) approved Connect with us! Listen to our podcast: Pharm5 Watch us on TikTok: @LizHearnPharmD Follow us on Twitter: @LizHearnPharmD References: Eckburg PB, Muir L, Critchley IA, et al. Oral tebipenem pivoxil hydrobromide in complicated urinary tract infection. New England Journal of Medicine. 2022;386(14):1327-1338. doi:10.1056/nejmoa2105462. Amgen announces positive top-line results from phase 3 study of ABP 654, Biosimilar candidate to STELARA® (ustekinumab). Amgen. https://www.amgen.com/newsroom/press-releases/2022/04/amgen-announces-positive-topline-results-from-phase-3-study-of-abp-654-biosimilar-candidate-to-stelara-ustekinumab. Published April 18, 2022. Accessed April 20, 2022. Jeremias S. Amgen releases Positive Phase 3 results for Stelara Biosimilar. The Center For Biosimilars. https://www.centerforbiosimilars.com/view/amgen-releases-positive-phase-3-results-for-stelara-biosimilar. Published April 19, 2022. Accessed April 20, 2022. Ezekowitz JA, Colin-Ramirez E, Ross H, et al. Reduction of dietary sodium to less than 100 mmol in heart failure (Sodium-Hf): An international, open-label, randomised, controlled trial. The Lancet. 2022;399(10333):1391-1400. doi:10.1016/s0140-6736(22)00369-5. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure. Journal of the American College of Cardiology. April 2022. doi:10.1016/j.jacc.2021.12.012 Commissioner of the Coronavirus (COVID-19) update: FDA authorizes first COVID-19 diagnostic test using breath samples. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-diagnostic-test-using-breath-samples. Published April 14, 2022. Accessed April 20, 2022. Pharmacypracticenews.com. https://www.pharmacypracticenews.com/FDA-Approvals/Article/05-22/Third-Biosimilar-to-Bevacizumab-Approved/66766. Published April 19, 2022. Accessed April 21, 2022.

Aotearoa has the third highest rate of inflammatory bowel disease, or IBD in the world, but essential medication is still unavailable due to Pharmac's budget. Ustekinumab, otherwise known by its brand name – Stelara was approved by MedSafe in 2018 and is already funded in Australia. Crohn's & Colitis NZ petitioned to get Stelara funded here last year - receiving 30,000 signatures. This led to Pharmac testifying before the petitions committee in October last year – where they said Stelara is needed but they still don't have the funding. Sam Clark spoke to the Chair of Crohn's & Colitis NZ, Dr Richard Stein about what has happened since.

BENZINGA CANNABIS CAPITAL CONFERENCEThe premier gathering of cannabis entrepreneurs and investors in North America returns for a 2-Day Hybrid Event on October 14-15.Speakers will include $SNDL and other major Cannabis Companies, for more information visit https://www.benzinga.com/events/cannabis/Episode Summary:Thursday TradesStocks talked about on the show:$INTC $UPST $SOFI $SWBI $VIAC $STAB $NGTF $SOVOGuests:Daniel Creech Curzio Research 2:00 Statera Bio CEO Mike Handley $STAB 10:00 Nightfood CEO Sean Folkson $NGTF 30:00SOVOS CEO Andy Hovancik $SOVO 45:00https://www.curzioresearch.com/Hosts:Aaron BryTwitter: https://twitter.com/aaronbry5Hot Stocks Luke JacobiTwitter: https://twitter.com/lukejacobiJason RaznickTwitter: https://twitter.com/jasonraznickSubscribe to all Benzinga Podcasts hereGet 20% off Benzinga PRO here Become a BENZINGA AFFILIATE and earn 30% on new subscriptionsDisclaimer: All of the information, material, and/or content contained in this program is for informational purposes only. Investing in stocks, options, and futures is risky and not suitable for all investors. Please consult your own independent financial adviser before making any investment decisions.Unedited Transcript All right. All right. What's going on, everybody having. Whew. We are back at it, wine and down the end of the week, another dreary to Detroit day here behind me. I hope everybody's got a little bit more sunshine than we do. It's also very cold. I'm now wearing a light jacket in the morning, but what's going on guys.Market is ripping again. We are back to where we were before that Monday sell off, you buy the dippers out there. All of you by the dippers. I was not wanting. Congratulations to you. Round of applause, pat yourself on the back, you won a game. Uh, you know, I'm going to go ahead. Let's just look at this, this chart aspire really quick for a second, and we're going to zoom it out to a year and then we'll go to five years.Uh here's the one year chart is by, by the day. Tried and true. Uh, here's a two-year charter spy by the dip tried and true five years. All right. I guess at the, by the dippers, just always seem to win this one. Uh, but what's going on guys? This is the power hour. This is the trade idea show. That's why we spend this time together every single day.So if we are not delivering on ideas, call us out. You are empowered to do that in the chat. We're going to get rocking and rolling. Uh, first op we're bringing in Daniel from Curzio reading. Good. Good, good friend to Frank over there. Uh, and Daniel's going to be dropping some ideas on us. He's gonna be talking about the China situation a little bit, I believe.Uh, and then we, we have three public company CEO interviews today. Jam pack guys. Okay. Three public company's CEO interviews. A lot of them may be stocks that you're not familiar with. I'll give you the tickers there. S T a B N G T F and S O V O. Uh, so, so again, S T a B N G T F S O V O a, but without further ado guys, uh, let's go ahead and bring Daniel from Curzio research in there.And when you, if you have takers, drop them in the chat, uh, I see, et cetera, ETCs already go and he's got his affirm on there. He's got his hymns on there. Um, and, and, yeah, let's get these in here. Solar ops. We're talking about the cannabis. I am not in any of the cannabis stocks now, but, but, but maybe I ought to be, but let's ask Daniel, Daniel, are you in any of the cannabis names?Um, not right now. No, but, uh, they've been coming across the headlines a lot. And first of all, thanks, thanks for having me great to be here. Um, but if I were to look at something in full disclosure, I don't have it and I've been kicking myself, but , uh, if you want to pull that up, there are basically a roll-up company that does a medical marijuana and the facilities that they're going to use to produce and grow and distribute.And that's char has been absolutely beautiful from an investor standpoint. Five-year chart. Yep. And, uh, those guys, uh, I believe it's wall street guys that just got together and man, they they've just been knocking it out of the park. So that's the one that I would look at first, other than the big names Tilray and those et cetera.But man, a friend of mine gave me that under a hundred and I just kept thinking, all right, I'll wait and wait and wait. And, uh, that's, that's frustrating, but that's investing that's okay. Uh, and, and Daniel, but before we hop into it, uh, give me a little bit of your background. Tell us, tell us about your trading investing career.Um, and then let's dive into some time. Absolutely. So I joined a Frank Curzio here at Curzio research. Uh, coming up on four years. It'll be four years this October next month. And my background before that was, I started in the brokerage business as a financial advisor, uh, had series seven and 66. Then didn't enjoy that.I like the research side, but not the front office standpoint. They believer in savings and investing. And on the saving side, I'm big into whole life insurance as a, as a wealth management tool. I know that raises a lot of red flags and always gets a good conversation started, but that's for another time, I can argue that until I'm blue in the face.And, uh, then when I was listening to Frank's podcast and following him through his career, and when he said that he was starting his own shop and wanted an analyst, I threw my hat in the ring and here we are going on four years. Uh, and give it, give us the short insurance pitch. The short insurance pitch is if you're disciplined enough to say, if you compare a whole life insurance policy to a bank account, there's no other product out there that is quote unquote as safe and reliable.And it gives you the opportunity to earn interest as you use your money. And there's a big difference between the interest you earn and the interest you pay with the flexibility on that. It's a fantastic wealth building opportunity over the long term. It's not a trading deal. Uh, if you're, if you're old right now and I don't mean to be rude about that, uh, that's what, you know, everybody thinks they're too old for everything these days, but, uh, if you're anywhere under, I'd say 50, you ought to really give it a look and most policies are set up.In favor of the insurance company, meaning higher commissions, and you can split those premiums up and infinite banking process. If you Google that, you'll, you'll see a lot of good stuff. Uh, infinite banking by, uh, Nelson Nash. I believe I'll tell my head as a great book to dig into. All right, there we go.And if anybody has a question about the insurance side, dropped them. And I'll pass it along to Daniel, but all right. Let, let, let, let's get back to the stock side. What what's on your radar right now? What are you thinking about? We, you, you gave us a cannabis name to look at already, but, but what else?Yeah. And that was driven by, uh, you know, if you, you guys are all market junkies. So as you're looking at headlines and everything, uh, the biggest lesson that I'm learning and, you know, I don't have a crystal ball or anything, but you gotta be able to decipher. News to act on and what to ignore. And when you just, when your market junkies and you see a lot of things coming across your desk or your eyes, uh, in my opinion, headlines around pot stocks kind of went away and now they're coming back and I say, they're coming back over the last month, at least in my opinion.So, uh, and that's driven politically, uh, there's a lot of headlines about, um, there's a group of. I think there's a bill in the house or the Senate. I'm sorry, I don't, I'm on the fence there about protecting banks that do business with, uh, pot stocks, because that's a big red flag right now. Cause you still have this illegal NIS at a certain level.I mean, it's kind of scary to think about, Hey, the feds can basically go in and shut anything down, but we're not going to. So we're in this process of, Hey, this is a law, but we're going to ignore that. Uh, we see a lot of that with politicians on both sides of the aisle. So that's not anything new. That's, you know, I look through the world from a political and economic lens.Uh, I think everybody should do that because it literally affects everything in our lives, in reality, as consumers and individuals. Okay. Alright. And I'll, I'll draw, I'll throw mine in the ring too. I'm going to throw in the, the one that everybody thinks about, but till Ray, uh, Erwin Simon, CEO of Tilray founder of Hain, celestial, good friend of Benzinga.Um, I, I, he he's, I followed his career for quite a while and he's just such an incredible operator. Um, and, and so if I had to pick one, I'm picking the track record of, of, of his, on the management side and that's where Tilray would be my plate. And that's great because you want to focus on individuals. I mean, when you, when you don't have an investment that you can control, so it's not close to the vest you want to invest in management teams.Um, Frank talks a lot about that with, especially in the resource sector, you want proven management teams, you want skin in the game. So if that gentleman and you know him like that, that that's a, that's a check mark on the, on the good side for the teacher. Yeah, absolutely. All right. Well, what else is on your mind?You know, Yeah, we'll go from a boring to exciting. So low-hanging fruit. Uh, Intel has dropped the ball for a number of years. They've let you know, their lunch has been eaten by their competitors. They have a new CEO and I'm going to butcher this, but pat gins learner, and he just took over in February of this year.And I think that this is a situation where you can buy it and forget about it. I have a little bit of a full disclosure. You earn a decent yield. And I think that as there's more volatility in the markets, and if you see this transition from growth to value, like everybody's warning about or volatility, you're going to go into hard brand names, solid brand names with good balance sheets.And they. Just have to quit screwing up all the time, in my opinion, to get a higher price, uh, the new CEO's got big ambitions. That's what I like to see either. They're going to invest a lot in fab centers, uh, semiconductor buildings over the next several years. And that's a huge secular bull market.That's not going away anytime soon. So Intel, if it's not exciting, But I do think that that's the lowest hanging fruit out there on a, on one of the big, yeah. And looking at some of the multiples really quick. I mean, it seems like a pretty cheap stock. So we're looking at a forward PE ratio of 12. Um, I don't have the S and P 500 handy, average handy off the top of my head.Right. At least in the twenties, uh, and then a price to sales, a 2.8 versus that one I know S and P average is, is a little bit over four. So, so it definitely seems like a relatively cheap stock. Yeah. And you can argue, I mean, the, the lower PE uh, forward P against its peers is warranted right now, because again, they've been dropping the ball so many times, so this new CEO starts to get some momentum, starts to prove that they can show results.I think that you can see that P rice faster than the actual results in reality. Markets are always forward-looking and that's exciting. That can be good or bad, but again, you get a few, uh, you get a few check marks on this guy's side, and I think it could just take off and easily be, you know, 20, 25% and then kind of find that new normal and hang out there for awhile.And again, you get paid to wait and are you really worried about Intel going bankrupt? I'm not, but you know, that's a good, that's a good hiding spot. And I don't think it's going to be dead money going from. Yeah. And check this out guys. I, I just, I just want it up an income statement really quickly. Uh, you know, th this, this top number that we have here that I'm trying to highlight, uh, th th this is quarterly revenue, and I mean, we're looking at like five quarters in a row with.Literally no growth. Um, you know, we, we zoom it out to annual revenue and we're getting a little bit of growth there. Um, but, but not, not crazy exciting. I think that's what Daniel's referring to. Yep. Absolutely. All right. All right. What else you said you're gonna start pouring and taking. That's boring. So a upstart U P S T is the taker and a quick, uh, are you familiar with this company at all?I am going to Lockton. Who's also a good friend of Benzing as is very, very hot on this stock. A couple of times to us it's been absolutely going crazy lately and quick, a rabbit trail here. You guys need to be going through 13 F filings. Uh, there's free websites out there and that's just great use the power of the internet.We've never lived in a better time where guys like me on 35 can take advantage of, I mean, the amount of resource we have or the amount of information we have for free right now over the internet. It's just a huge step forward and it's just blind, dumb luck that we get to live in this period. None of us picked when we got to be born in order to get some of this information at all, you'd have to go to libraries, different things.So take advantage of there's 13 S I was going through those, uh, Dan Loeb of third point. Somebody I really respect and you know, like to listen to anything he writes or says and read anything he writes. So I just saw this in a filing and I just went through ticker symbols. Um, they're in a major growth platform where the banking and financial services are using a lot of AI.They have been for some time, but it's getting a lot of capital to flow into that space right now. So they do personal loans, consumer loans, and they basically go in and show banks, Hey, we can show you how to make more loans with a. Risk tolerance and a lower default rate. And why wouldn't you pursue that or look into that if you're a bank and that's a scalable business with all the loans and trillions of dollars out there.And as you can tell, I would wait for a pullback. This is definitely a momentum stock. Uh, we were just talking about, uh, PEs with, uh, Intel. I don't know what it is off the top of my head, but it's gotta be through the roof on. All right. And, and I want to throw this one out to the chat to, uh, is anybody in this Docker to anybody get into the stock from the show?Because when we first talked about it, it was in the seventies somewhere. I, this is the first time I've looked at it in a wild scene, three 40. I, I clearly missed the boat. Uh, but, but I'm curious if anybody out there caught the rip in this one. And so, so Daniel, I like, I like what you're picking up on it that you want to wait for for some of that pullback and.Let's let the momentum co come to a close, um, with the model like you're saying is so good. It's so reoccurring too, right. Is once a bank becomes dependent on upstart for, for lending and being like a core part of that engine is as to how they're pricing and deciding who to lend to. I would imagine that that's impossible, damn near impossible for these banks to rip out of their operations.Yeah, absolutely. It's, it's a sticky product and it's scalable. So as an investor, that's a great thing to have. So, you know, be, be prepared for volatility. Um, I, quick story. I told my dad about this around $95 a share, and I said I was buying it and I didn't. And he did, and I wasn't lying to him and it went.50 or whatever. And now look at where it is. He didn't sell it. So he's very happy. But of course I was kicking myself. I think I bought a gold stock or whatever, which I'm still down on. Uh, but I said, Hey, you need to buy this. I should buy this, but I'm going over here. And he did. So that's good. All right guys, and check out the quarterly revenue on this one.We're looking at four quarters of data right here on upstart again, sticker U P S T. We went from $51 million of sales to $194 million of. In four quarters. That's I don't know if there's other public company that operates at this scale that, that that's had that kind of growth. I mean, that's, that would be, if somebody out there wants to go run a quick stock screen, so set maybe market cap threshold somewhere, uh, or, or may set a revenue threshold outlet, like 50, a hundred million dollars and see if any other companies have this kind of growth.I, I would imagine that that there's not one. All right. So, so you're making it more exciting. Do you have a third one for us? Yeah. Along the same lines with the financial platform online platform, a sofa Jeffrey's just came out with initiation yesterday. I've been watching this. It's been volatile as well, and they put a PR $25 price tag it, price target on.If I, uh, if I remember correctly, which is damn near 50% upside from current levels. Well, depending on what it's doing right now today, but. You have a lot of money flowing into this space. It just makes sense from a standpoint and hell their name is on that, a beautiful new, however, billion dollars. It took to build that a football stadium out in California.Yeah. That, that, that, that was definitely an expensive sponsorship. I guarantee that. Yeah, I see, I see I'm using my trusty Benzinga pro here, looking at the recent analyst price targets. Uh, you know, I see the Jeffries yesterday that you mentioned at 25 Mizuho out there at 20. And then the, the low of the street credit Suisse came out about two weeks ago at 16 and a half.Um, and, and, and so, so BA basically, uh, is, is the thesis on this one? Daniel it's it's right. Space, right stock within that space. Yeah, absolutely. It's just, it's more of a momentum play. Uh, I liked the idea in general, but it's just when you have massive amounts of money flowing into that and strong brand types, uh, those are great for trading opportunities and then they can turn into long-term holdings.Okay. Yeah. And I'm zooming into a five day chart right now. So it's what we're looking at. I believe our five minute candles, let me get a, from a 10 minute candles, five day chart. Um, and, and we, we definitely see that rip higher with the market yesterday, uh, in, in tack down another 2% so far today. So, so, and let me throw this one out here, but I definitely see this symbol come up if anybody has long.So if I take her S O F I give me the one in the chat, if not give me the two, I want to get a sense of where the crowd is at on the. Uh, I I'm not in so far, but I do own a couple of the online brokerages. Um, one that I'm getting hammered in right now, uh, I've trimmed the position, but still have a little bit of a position in his tiger.Ticker T I G R a. It's like, like the Robin hood of China, Singapore, et cetera. Um, wow. We have a lot of Sophie owners in the chat check this out. Okay. So a lot of people who like sofa, I can get behind that. All right. Okay. All right. Daniel, anything else for us before we gotta hop? Uh, yeah, if you want to have a fun, uh, political pick a Smith and Wesson brands, uh, they're a pure play on fire symbol on that one.S WPI. Thank you. You can see, we impressed. So that was the first you're you're on stock number four, and I knew the first three. Okay. There you go. All right. SWB. So that massive spike there was after an earnings release, uh, they've recently, uh, I think right around the first of this month, September, they did their quarterly earnings, but that massive spike there, that what you can see on the chart is they blew out the numbers on the earnings release.And then it looks like the Reddit crowd got involved because look at that massive sky high, I mean, that thing just went parabolic for several trading days. Uh, this is a pure play on firearm. I know that's a touchy subject politically, but when you look at the numbers, the FBI background checks and things are falling year over year because of the strong, strong comps that they're compared to during the riots and the 2020 and all that kind of thing.But 50% of new gun buyers are women. Um, everybody I'm a small town guy. I grew up around firearms. So I'm biased as everybody else is, but I'm biased towards them. This is a company with no debt. They are. In a position to continue raising their dividend. Uh, it's not impressive. It's not a high yielding thing, but they are buying back stock as well.And you have a solid company with an amazing brand name and you have a product that people are, um, you know, it's, they have a huge demand for their products right now, their backlogs or their inventories about an eight weeks, which is kind of where they want to management. They're going to have issues along with everybody else with supply chains.When you get a great business in a fantastic financial shape and a well-known brand, um, that's, that's a good one right there. So, and it's got a decent short interest. So that, that spike that you see on the chart that could easily happen again. Alright. I like it. It's interesting. I have, uh, let me throw this edgy Daniel, then we're going to have to hop in a minute here, but here here's my take on the gun stocks is I feel like literally always, or at least.Once a year for the last 10 years, there's like a shortage. And like, there just becomes this narrative, all of a sudden that there's a shortage on guns or there's a shortage on ammunition. And then just a ton of energy pops into these stocks. And you know what I mean? It's it, it just seems like, uh, like, I don't know, like I'm sick, I'm bored of the narrative.Yeah, it does. I mean, and you're right. That does happen. I will tell you the biggest risk I see. This is, and why I think you have some short interest is you have such a political movement and like your major funds and investment companies like BlackRock and those, they have, they kind of shun these kinds of stocks.So you have a great business. You have high profit margins, but what's going to be. The big guys from flowing more money into these stocks is political reasons. That's your biggest risk in my opinion, but yeah, you're right. They, they get hot. They could be used as tradable securities. So that would work out for your listeners, but I wouldn't feel bad about buying and holding this either, but yeah, if you want to trade the pops and, uh, you know, sell on the rips and buy on the dips, that's a great idea.Right? Alrighty, Danielle, I appreciate you hopping on with us. How can folks stay in touch? Where should they go? What should they check out? Yeah. Uh, my email isDaniel@curzioresearch.com. Be sure to check out Curzio research.com and our wall street unplugged podcast that we now do over Tuesday, Wednesdays and Thursdays every single week.Alrighty. There it is. Thank you for joining us, sir, and dropping the ideas. All right. All right, guys. How was that? I see recurring theme of the chat and talk about Viacom. We will get the via, comes to your V I a C, but, but without further ado, w w we're we're going to keep the show rolling. Uh, we, we've got a nice slate of guests coming in for us today.Uh, first up CEO said, taro, biopharma, Mike Handley. I'm going to go ahead and let's bring Mike onto the. How are you doing today, sir? Thanks for that. Absolutely. Uh, and, and everyone, the stock symbol is ticker. S T a B said Sandy tango alpha Bravo, Bravo. Um, long week. Um, but, but, but my, my, I I'm one for, for a good stock symbol.You know, if, if, if a, if a company has a good ticker symbol that like automatically notches it up in my book, so maybe we could just start there for a second. Uh, why. Yeah. Interesting question though. Thanks for having me again. Yeah. Stab is a Sitara biopharma, obviously ticker symbols are a little hit and miss.Um, we were going for sta T but uh, stab is memorable. Um, and it also goes with our tagline, take a stab at stopping. Right. So, okay. We think it's more memorable than most taglines. Absolutely. No, that's great. I love it. It's like some of the ETF funds, right. I read out to them to I'm like, I don't know how you guys pick the ticker symbols, but if there's like a group or like, you know, something you survey include me in there, I haven't gotten any responses, but I love the memorable ticker symbol for sure.Absolutely. And, and, and Mike T taking a step back from the ticker symbol to the company. Uh, could you just give us a little bit of an overview on Satara for anybody out there who might not know. Yes, the terrorist, a, a company that just became public, uh, July 27th through a combination merger with Cleveland Biolabs, which was a NASDAQ listed company.I've been running a state Tara since April of last year. Um, we, uh, talked to Cleveland Biolabs synergistic platforms. So we're most looking at immunotherapies and, uh, it looked like a good combination of two companies. So we combined the two companies officially July 26. Or July 27th. Yeah. And I've been trading since then, and I've been working with circuits and getting visibility for our pipeline and we're about ready to initiate some Wade stage drug programs, uh, that we're really excited about that should help patients and deliver some new immunotherapies to the field.Excellent. And Mike, you, you, you, you mentioned, I think it was April, 2020, that, that, that, that you joined the company, is that accurate or that you've been running it. Yeah, I've been running it since April, 2020. We've done two acquisitions, um, raised or secured over a hundred million dollars in gone public.So it's been a busy what? 17 months. Yeah, no kidding. So, so, so, uh, the, the next question I have is, uh, is on background and, and I, I sort of have two pieces of it. Um, and, and you can pick the answer one, one, or both, uh, but, but either what, what was the impetus for the company? Or can you talk a little bit about your career prior, prior to.Yeah. Yeah, I'll answer both. So I've been in front of biotech for 24 years of running companies for the last 15 years. I'm very interested in the biotech space. Immunotherapy space started off at Amgen Genentech, which are the two big giants and biotech, of course, Genentech bought by Roche now, but Amgen still, uh, independent, uh, took over 17 products to market.You know, raise close to half a billion dollars and, uh, Brandon's is the terror. Like I said, April last year, they had a very interesting portfolio and uh, thought, um, this would be a great public company, a great opportunity to get some drugs, to some much needed patients, um, that don't have any other alternatives that are.Uh, so very excited about our platform, multiple shots on goal. We've got a great story and it resonates well with the street, from our interactions and our non-deal roadshow we've been doing. So we're very excited, better than current position. Okay. And I'll, I'll pick up on that roadshow comment that you made, you know, and w when you're going out to wall street and you're talking about the company, uh, you know, what, what aspect of the business is, is getting investors most.Yeah. Great question. So if you follow the biotech sector, we've seen immunotherapies just exploded in the past five years, I'll use two examples, Humira, which is a TNFL Footlocker sells about $19 billion a year. What's number one, uh, drug selling in us. And I think the world, and then you look at Keytruda.Merck's drug is a PD, one PDL, one inhibitor. It sells at 13 billion. It's also. Um, our approach to immunotherapies is a little bit different than what big pharma is doing. Those particular drugs suppress the immune system, uh, as in Humira. And they do that, um, to account for, um, uh, Crohn's disease, IVG rheumatory arthritis, and then the cancer drugs take the brakes off your immune system.So in effect, our narrative to wall street is the current immune therapies out there or. And they're generating a lot of cashflow and they're helping patients, but they also come with a large amount of side effects because you're suppressing the immune system. Um, in the one case with the Humira and other TNF, alpha blockers and the other cancer cases, you're increasing the probability of hyper inflammation in those patients.And that's been a cause and a concern and a warning for Keytruda, both great drugs, uh, both help patients, but we think there's a better way of doing immunotherapies. And that's what we're telling the street. And they're gravitating. Okay. And can you talk to us a little bit about him? Question in specifically the integration stuff.Yeah, I'm close was the second company we acquired. Um, they're a research driven company with, uh, cashflows and, uh, we're in the process right now of integrating them into our R and D platform. And they're working on our second gen, uh, immunotherapies. And we've got a couple of, uh, potential interesting candidates we're working through, but the inquest simply adds to.And, uh, we're building, I think one of the more interesting and the largest tool, like reception pipelines, um, in the U S if not the world, and that provides us with, again, a lot of shots on goal and a lot of ways to help patients. Okay. And I guess maybe taking a, a step back or a step higher than, than, than inquest specifically.Uh, but, but how do you see M and a fitting into the company's roadmap and why have you made the choice that, Hey, that that's the route that we're going to pursue to really grow. Yeah, I'm a firm believer the, uh, Biven bill, right. It's a lot of companies out there that have interesting technologies or platforms that would take me, you know, months to years to replicate the same thing and a much higher dilution to our shareholders.So, um, being opportunistic, looking at companies with the us. Uh, or complimentary or technologies that are complimentary. Um, we'll definitely use our public stock as currency. And like I said, we're well capitalized and we'll be opportunistic about what we go out and acquire, but it's definitely in the mold of our strategy going forward.So look at M and a, and be opportunistic about increasing our pipeline, both depths. Okay. And Mike, let, let, let me ask you one more question. And this one is always a tough one. Uh, but, but if you had to name one, one thing that you're most excited about, so somewhere on the roadmap, what, what would that one idea.Yeah, great question. Everybody asks me, um, obviously cancer therapies are near and dear to everybody's heart. Everybody knows a relative or friend that has cancer, and we've got some very good cancer therapies for developing an adjunctive treatment. Um, but probably the drug program I'm most excited about is our Crohn's programs.So what we've seen in phase two data is, uh, double the rate of remission in patients who take a once a day world. So current standard of character, marrow, injectable, biologic, um, you get a remission rate of in the low thirties. Um, our what our data, what we've seen is about a 67% remission rate, four weeks, once a day dosing, that is very compelling.And then the other thing I'm really excited about Crohn's is currently for pediatric Crohn's patients. There's nothing out there that, uh, Works. Well, all of that is black box warning. And as kids develop their immune system, it's really hard for them to be on these biologics, like Humira, Stelara, and Remicade.So we're running a phase three pediatric study that should kick off by the end of the year, um, in, uh, pediatric Crohn's patients. And we believe this will be a viable alternative to all the kids out there suffering from Crohn's disease. Awesome. Mike, I appreciate you taking the time to come on with us today.CEO said Tara, a ticker S T a B. And as I said, I do love that symbol and I love the memorability of it. If that's even a word, digging a stab at cancer. Awesome. Yeah. Appreciate it. Thanks for, thanks for your time. Have a good day. Absolutely. You as well. All right. All right, producer, Amy, what do you think.Love it love the company. Love the ticker. Great to have Mike on. Um, but Luke, we have an absolutely packed power hour show. Today. We brought on Daniel from wall street and unplug. We brought on my from Sitara buyout. Now it is time to bring on Sean C Sean folks and CEO of night food. Um, so without further ado, oh wait, wait, wait.Celsius is a hundred bucks. No way. Wait, did we ever get the video of Jonah shock? He said, he said he was going to shut you down. He did it leap and you're sleeping on Celsius. Sorry. Um, yeah. And then you also saw the news that Jonah said a Celsius is sending us some, some drinks to Florida for the conference.Yeah. Guys, if you want to come hang out with me and producer a B in journal up them and put the link in the chat, come say, hi, it's going to be about. That's really the only thing that's keeping me going at this point. So there you go. It will be a good time. Um, all right, Luke. Well, without further ado, I'm going to go ahead and bring Sean folks in on the show.Sean CEO of night food. Thank you for joining us on the Benzinga power hour. How are you doing on this beautiful Thursday? Great. My pleasure. Happy to be here. Great to have you, um, before we get started, do you mind just giving some, uh, background on the company for maybe some of our audience that may not be familiar?Sure. So across the country, On any given night, you've got over a hundred million people that are snacking in between dinner and bed. Uh, the most popular choices tend to be things that are loaded with excess fat, excess sugar, excess calories. Cause that's what we're hard wired to create. So you've got all these snacks being consumed, and they're not only unhealthy, but they're actually disruptive to sleep.When you eat the wrong things before bed, it can impair your sleep quality. So knowing that so many people are snacking at night on a regular basis, what night food does is we deliver healthier snack options that are specifically formulated to satisfy those nighttime cravings, but do it in a better, healthier, and more sleep friendly.There's plenty of companies out there over the last 10 or 15 years that have launched and had a lot of success with better for you snacks, which are generally healthier in terms of, you know, protein content or sugar content or caloric content, but only night food has looked at. Knowing that people are snacking within that hour or two before bed, what should we be putting in our bodies and what shouldn't we be putting in our bodies to make sure that we get the best night of sleep and sleep is becoming more and more of a challenge for a lot of people, uh, especially now with COVID.So we think the timing is great, and we think there's a billion dollar category to be had here in the category of nighttime. So is this something, I guess that took a lot of, you know, scientific research on, on night foods and to figure out like what it is specifically about, um, you know, what's in typical ice cream that can disrupt someone's.Well, I mean, there's been a general consensus for quite some time, and there's been a lot of research over the years. Uh, you know, excess sugar, uh, fat and calories are problematic. Um, you know, there are certain nutrients that can be beneficial, magnesium, calcium, zinc, vitamin B6. Uh, so the research really existed.Uh, and when we launched our, our challenge was. You know, to formulate a great tasting product, uh, with all these ingredients that can satisfy those cravings in that way. So, uh, really we stood on the shoulders of the existing research, which was out there. And it's really interesting because with so much snacking already happening at night.See, this is, this is not a behavior. That's, uh, it's not a trend. It's not a fad. This is how humans are wired. We're wired to crave these things at night, so it's not going away. So there was a lot of talk and a lot of research before we launched, but nobody had ever launched a product into the category, which we thought was really interesting.Now we've got Nestle, we've got Unilever, we've got Pepsi. They're all talking publicly about this category. Um, but, but we're the only ones operating in it. And so the challenge for us was not really to figure out what our snacks should be. An ice cream is the first, you know, what they should contain. It's more about really educating the.Got it. Yeah. And I mean, it sounds like, I don't know if it's fair to say, but you're kind of, um, you know, hacking the human, like hardwiring of wanting to crave these things, but then we, you can eat these things, but in it, and it tastes like what we're craving, but it doesn't have those kinds of detrimental effects on sleep.Is that. Yeah, that's exactly right. I mean, you know, th the reason we crave these types of things at night is because putting extra fuel inside your tank before fasting is a survival mechanism that really served well, you know, the caveman ancestors, uh, you know, if, if they didn't have the resources, if they didn't store excess fuel inside their body, in the form of calories, they were less likely to survive.And specifically before the nighttime fast, that's when those cravings, that's why appetite peaks. Um, so yeah, what we're trying to do is, um, make sure that, that when you do give into those cravings and most people do that, you're doing it in a way that's beneficial and not detrimental. Got it. Um, so real quick on the business side, um, I understand.Uh, you know, you guys do a lot of I'm on the website right now, a lot of direct to consumer. Um, I see, you know, shipping is only 6 95 for an eight, eight pint order, but what about all on the B2B side, on the business to business side? Uh, you know, where does night food stand as far as with partnerships with, uh, you know, places like hotels and chains like that?Yes. So, so from a retail distribution perspective, we're in divisions of Albertsons we're in, uh, almost a thousand Walmart stores across the country. And other supermarkets and we're expecting to add quite a few more supermarket chains, uh, in the spring. You know, those meetings that are going on right now and things are being finalized, but the real cab.And what's going to be happening in the next few weeks and months is the hotel launch. So we were making a big push into hotels prior to COVID and then obviously COVID slowed things down quite a bit, but, uh, in the hotel environment, you know, everybody's been in the supermarket and you see there's there's six or eight doors of ice cream.There could literally be hundreds and hundreds of different varieties, different skews in there in the hotel environment, you've got a consumer that's typically purchasing for more immediate consumption. Our packaging, as you can see there says sleep friendly right on the front. We sell very well in the hotel environment in the past, we've sold pint for pint with Ben and Jerry's pint for pint with hogs.And we got contacted, uh, late last year. One of the leading global hotel brands just conducted and completed a test of night food in several of their hotels. And the test went very well. And what that's going to lead to is a national rollout of the ice. And what we believe also could be the ability to very quickly introduce additional product formats into that hotel environment.So the product sells very well. There, it's a great opportunity to capture high margin businesses, much more profitable than the supermarkets, but it's also really supportive. Of the supermarket distribution. Uh, we've seen, um, we've seen RX bar get into gyms and use that gym distribution to support their supermarket rollout.And then they sold to Kellogg's for $600 million a couple of years ago, Oatley also, which just IPO a few months ago, they very publicly stated their strategy is to roll into coffee shops. They've got to deal with Starbucks. Consumers will interface with the brand in that environment. And that will build trust that build awareness, and then the consumers run into the supermarket and start buying the product.So we think the hotel piece, obviously it's going to be great revenue contribution, great profit contribution, uh, but also really, really supportive of our supermarket expects. Yeah, that that's good insight there as to how you can kind of raise brand awareness through some of these, uh, B2B deals and that way, um, you know, bolstered the, the B2C sales as well.Um, so, so you mentioned some other of the big ice cream players out there. Um, do you see Knight food as a potential, like takeover target down the line? Uh, I do. I think it's, I think it's going to be inevitable. I think we're going to force their hands. You know, uh, when you think about it, Nestle and Unilever are the two largest out there, and they've both publicly expressed interest in this category.And, you know, especially being in the hotel vertical, it's really going to cement us as, as the category king and the category leader, you know, we've seen five-hour energy still sells over well, over 80% of the energy shots in the country. You know, every, everybody in the energy drink business just about has launched a shot and five-hour.Just swats them away. And I think, you know, if we play our cards, right, the same thing will happen in the nighttime nutrition space. And specifically being in the hotels makes it really hard for somebody to come in and try to outflank us. It's a lot easier to do if you're relying strictly on supermarket distribution, there's a lot more opportunity for the big players to come in and try to push us around.But in that hotel space, I think it's really going to insulate us quite a bit. Um, it's also going to really accelerate. Um, our growth curves so that by the time anybody decides they want to get in, we're going to be running out with really tremendous revenue growth as we scale into the hotels. And, you know, even if the first company decides they're going to try to launch against.Then what is the second company going to do? Are they going to play for third place? Are they going to try to require, uh, the category pioneer? So, um, I do think it's inevitable. Uh, you know, we've got some revenue targets that, you know, when we hit those, everybody's going to have to decide how are they going to.One thing. I didn't mention almost half of all snacking takes place at night. This is not a small niche. This is not five or 10%. This is almost half of all snacking. And it's not just Unilever and Nestle. Everybody knows about this Mon delays and Kellogg's, and Hershey's any company that's in the snack space.They know when the Oreos and the Doritos and the Ben and Jerry's are being eaten. And once we show that consumers are wanting and willing to make a small change in order to support better quality. Right, which is an easy jump for any consumer to make. Once these big companies realize that, then they know that the whole landscape of the snack category is going to change.You're talking about almost half of all snacking up for grabs. When all these cookies, chips, candy and ice cream are being consumed between dinner and bed. I don't think they're going to be able to lay off. I think we're going to be fielding. I mean, we've already been contacted by some of the companies, um, at least one of them that I mentioned on this call or.Um, I think the phone's going to start ringing once we start to really scale our revenues coming up. Got it. Yeah. That's exciting. I guess a, you know, a follow up question on that would be, how would you, uh, you know, quote unquote, you know, force their hands, as you said, you know, like what's to stop, you know, Unilever or, you know, uh, Ben and Jerry's whoever it is from going out and trying to develop their own sleep friendly.They could certainly do that. It's really not the way things are done. I mean, there was nothing stopping Kellogg's from making their own, you know, cleaner labeled bar. Uh, there was nothing stopping Hormel, which already owned Skippy, peanut butter for making their own organic brand. But no, they acquired Justin's.Um, and, and up and down the line, you know, uh, it's just not the way things are done these days for them to try to launch against us when they see a category pioneering. Growing at, at, you know, an exponential growth in a category where there's obviously going to be one king and lead player acquisition is the only way to go.Um, everybody else is going to be competing for second place and they all know that. Got it. Um, all right, Sean. Well, thank you so much for joining us on the power hour. Uh, but my final question thought would be, have you ever thought about doing a 180 and maybe making a caffeinated ice cream for breakfast?No, no, I've never heard about people have said we should make day food as well as night food. But you know, you look at the NyQuil analogy, right? And yes, they, they do make DayQuil now, but, but by, by, by commanding a specific day part, Luna bars, another great example when cliff made Luna bar as a protein bar for women, people said, Hey, you know, you're, you're eliminating a portion of your audience and the same thing with Nike.Uh, back in the mid to late sixties when they launched, but there's a lot of power in that kind of focus. And by being the company about nighttime snacking, when I was half of all snacking takes. At night, there there's power in there. We don't feel that it's limiting at all. We feel that it's laser-focused and it's not only going to be, uh, be more powerful in terms of our ability to grow, but it's going to present a more powerful, uh, value proposition to, uh, investors, whether that's our, our day-to-day shareholders or ultimately other conglomerates that might choose to enter the space through acquisition.Got it. Well, Shawn, thank you again for coming on the show today. I look forward to having you on again, anytime night, food has some exciting updates or news. We'd love to have you back on to kind of, uh, you know, bring that news to her. Fantastic. Thanks for having us. I know you mentioned Celsius hitting a hundred, you know, I've been studying Celsius.Um, you know, the, the chart is amazing and you see, there was years, you know, they were cranking away and the stock didn't move and now they're really getting rewarded in the marketplace. So congratulations to John and the whole Celsius team as well. Yeah, of course. You, you, you mentioned the chart, you a trade stocks.I don't, but I, I do feel a lot of questions from investors and certainly, you know, I'm studying Celsius to see, okay, you know, what, what was going on during those years? Where were, were, wasn't moving, you know, what changed? And, and it's a really, uh, really amazing thing to look at, but now I only do it because, because I'm asked.A hundred percent of my net worth is in night food. And, uh, my, my wife and I are okay with that and my kids. And we're very excited about. There you go. Who knew, who needs diversification. All right, Sean. Thank you for joining us. We'll be in touch. We'll be in touch. We'll we'll have you on again soon.Thanks so much guys. A B I was, I was late for that. Um, but. Aye. Aye. Aye. What I want to say. It was also in the chat, which was, uh, someone who, who said this in the chat. They have very cool labeling. I feel like a, uh cause I, everyone always like, whenever you take like a marketing course, they always say, oh, labeling and packaging is so important.And I think, oh, that doesn't work on me. And then here I am. I'm like, oh yeah, they have, they have cool label. I might try that because all that stuff, if that works is done on the subconscious level. So you're not actually. Um, you know, consciously saying, oh, I'm going to buy this because it's got better packaging, but you subconsciously do, did you not?I may have missed it. So I apologize. Did you ask for, for free sample? No, I forgot to do that. I don't know if Sean can still hear us, but if you can, you can email email, I'll send you our address and we will gladly take some free samples. Um, yeah. Spencer, the only question you caught was mine about the, the morning ice cream.Hey, if they're not going to do it, that might be a whole, whole new market out there. Can they, can they, I don't know if you can ship by stream in the mail, whatever, whatever, and you missed it on the, on the website eight by eight pints. It's only $6 and 95 cents. It's a great, I was preparing, I was preparing for our health care conference negative next week.So I apologize for, but I'm here now. I'm here for our next, our next guest, which I'm excited for AB. Um, we have Todd Lachman, who is the Sovos CEO. It's very exciting. The company is IPO in today. Um, and, and we are getting fresh new public companies on the Benzinga power hour. Nowhere else. Can you go on YouTube to find content like this?So smash the like and subscribe. If you haven't already Spencer, without further ado, let's bring Todd on this. There is that guys doing great to be with you today? Yeah, Todd, I'm sure you're very busy today with Sovos IPO in. Um, are you joining us live for I'm from New York? I am joining Vive from New York.Uh, the NASDAQ tower right here. Wow. How's the day going so far busy, but great. Uh, honestly guys it's, uh, I mean, what an exciting. You know, for, uh, for so most brands we're thrilled. Uh, know, we're just thrilled for the journey ahead. It's like to tell you more about it today. And so maybe let's just start with what, what, what the company is, and then I'll, I'll get to my, my, my real questions.So look here. Well, I've been in the industry for awhile, so throughout my career, Plus year time. And in CPG, I was, you know, across brands, categories, companies, geographies. I was always struck by the fact, you know, that you've got these smaller on-trend brands growing at the expense of the largest brands in the store.Some people call them challenger brands, disruptor brands at Sovos. We call them one of a kind brands, but I, I felt that there was an opportunity to create a company specifically suited in order to. Uh, have the talent, the culture, the capabilities, the infrastructure, to build a portfolio of these, one of a kind brands.I mean, w we look specifically for brands that have tastes superiority strong, consumer affinity, high quality ingredients with a cleaner label and authenticity at their core. And that's what we have with Rayos Michelangelo's Noosa, Birch benders, fastest growing food company in the U S uh, outperforming our categories by 25 percentage points.And the journey is just. Okay. Since we were just talking about it, uh, and I didn't get to ask our last guest, I'll ask you Todd, just about packaging and labeling and branding and, and just how important on a scale, like one to 10, how important is that for you? On a scale of one to 10? I don't know if it's, uh, it's, it's really important.Um, I don't know. Let's say it's like, let's, let's say it's a, you know, a seven, eight, you know, kind of what you're talking about, but what's, what's interesting. I think it's more important, uh, for brands like ours that are premium priced high quality. The difference is so different. What's in the jar that, you know, that is the most differentiating aspect for us.The package is. But what's doubly critical. Let's take a brand like Rayez. You've got whole Italian peel tomatoes, fresh basil, fresh onions, olive oil inside that jar, slow simmered and cooked and open kettles. And you've got the market leaders with paste and added sugar and added water and canola oil. So just to kind of highlight the difference in our products versus.The difference of, uh, you know, once they're, so with us, the reason we're able to command a premium price. I mean, Rayos is three times the price of the market leader Rayos is growing at 42%. We're almost the number two brand in the category and the market leaders are flat to declining. So what's in that package is really the magic that's delighting consumers.So, is it mostly, you know, brands under the Sovos umbrella? Are they mostly, um, you know, healthier alternatives organics, um, or is that just happens to be the case with a rail? Sure. No, all our brands, we look for brands with high quality ingredients and cleaner label. Let's say Birch benders has an organic offering, a high quality ingredients.Uh, basically almond flowers, tiger, nuts, uh, you know, all sorts of high-quality ingredients in those products. We have organic, we have a keto and paleo offering keto and paleo Birch benders, pancake waffle mix, two of the fastest spinning items. Then you've got a brand like new stuff, whole milk, real fruit, north American wildflower, honey, with a proprietary process.I mean, this is a great example of guys that, you know, we're, the category is going one way. How much taste can we take out of the container? We're looking at, see how much tastes we can put into the product. And that's why consumers are flocking to new Senate's it's growing well. Well, ahead of the category, very differentiated.Oh, go ahead, Spencer, go ahead. Have you, or maybe down the line, have you guys ever sold like individual brands to maybe market. We, we have acquired we've averaged about four acquisitions a year. We have not invested in asset. We have no plans to we're building a portfolio of one of a kind brands. And quite honestly, we have, uh, you know, plans to acquire more brands in the future.Uh, Y you mentioned the term CPG consumer packaged goods. Why would a consumer package goods company IPO right now? Why. Sure. Well, I, you know, I think just speaking for Sovos brands, we're of the size, you know, the scale, the profitability level, then it's appropriate for us. We've been, uh, you know, we were founded four and a half years ago.We're a $669 million of sales growing at 31% were profitable. This is not a story where I'm saying, Hey guys, I'll be back on in five years when I am profitable. We've been profitable from a, from day one. Uh, you know, so I think at this level, and then look at it, it provides us with, uh, with the balance sheet and the infrastructure and, you know, the sort of widen the aperture to whether it's talent, acquisition, future M and a it's just, it's the perfect time, honestly, for, uh, for Sovos to become a public.Got to ask you about the Al green in the room, which is just, um, uh, the impact that, that COVID the pandemic has had and on everything, right? Uh, whether it's supply chains, whether it's labor costs, uh, whatever. However, you want to answer this question and take it, but like what, what is the impact that the last year and a half has had on your business?Sure. So. Look, I mean, I think there's a few things that, uh, if you just think from a brand perspective, we have brands that have that taste superior brands that have strong consumer affinity with the type of ingredients that we have. They have a higher propensity to stick in a household after trial. Then highly substitutable me to mainstream brands.So we have gained the amount of trial that we've gained over the past 18 months has been prolific just during this, this horrible pandemic. And if you look at a brand like ratios, our penetration is double from 5% to 9.6%. That's why the brand is growing at 42% last 52 weeks versus, you know, the. You know, flat.So, uh, you know, what we've seen is we're gaining trial of our, you know, of our premium brands and they're sticking in the, in the household clearly from a supply chain standpoint, uh, you know, just like everybody, we've had to be really nimble and tenacious and keeping our products and supply. And I'll, I'll tell you one thing we're in a year, as difficult as it was in 2018.And a company of our size. We've got vendor of the year at target and supplier of the year at whole foods. Wow. Because you know, one of our core guiding principles is obsessed with the front line. You know, we're the more time we can be focusing on our retails or on the consumers, on our frontline heroes that come to work every day to make our delicious products.Uh, I mean, that was a real, a Testament to the fact that, you know, our, our phenomenal employees are working so hard to keep our customers in. So Todd, I don't know if you have kids, but it's oftentimes hard to, uh, to pick a favorite kid, but I'm going to ask you, I'm going to ask you to do it here out of the four brands, uh, currently right now under Sovos, which one is your favorite?Or maybe what's the most popular in your own household? Yeah, I do have three kids and we always joke about which job I'm not going to ask you that question. I'll ask you, Kyle Paul and Isabel are listening today. So I will, I won't treat. But, uh, I apologize. I'm going to tell you right now that I've got four outstanding children.So those portfolio with those, with Noosa, with Birch benders, uh, it, look, you got a brand like radios. That's changing the sauce category forever in regards to whole tomato sauce, you have nuisance. Is there a category in and of itself, it tastes, tastes like yogurt. And then we couldn't be more excited that we just added Birch benders to the, uh, to the portfolio, the fastest growing frozen waffle they're a brand.We just launched it into the baking mix aisle with some Quito offerings. So, uh, for four great children in the, uh, in the Soho's portfolio. Oh, favorites. Todd, is there a product category you're not in, but you very much want to be in right now. So great. So I'd say number one, we were at about seven categories.Now. We really like the categories that we're in today. I would say I'm not going to choose a category, but I would say that there are categories adjacent to ours or close to adjacent to ours, that we also really like, we, there are other sleepy categories that are in need of disruption or are being disrupted today by other brands that we would love at some time to add to the Sovos portfolio.So, you know, Some companies are sort of attracted to the category. that? Wow, this is like the place I've got to be. I'm not going to name that area, but there's, some of those were, you know, we're sort of looking at a different direction or those categories that, that, that are right for disruption. I'll tell you a category that we entered with ratios with soup.Everything is in a can. Why can't it? The consumer gets sued. That's not an, a camp. Well, until Rayos came in with glass jar. Absolutely delicious meal and a jar consumers. Couldn't get Superdome in a jar and now they can see that great delicious soup. And it's the, now the number five soup brand and only 18 months.Uh, last one for me, you mentioned you're in a target you're in whole foods. I assume you're nationwide. If you're in both of those locations, have you considered direct to consumer model? Sure. So we, uh, we're partnering well, their customers, whether it's clicker collect and on their retailer e-commerce programs, we do sell an example of what we do sell direct today.If you go on rails.com, we have great gifting baskets. We have some super premium rails, limited reserve products. So aged balsamic, white truffle marinara. We do sell a direct some, uh, some super premium, super, super premium products on the, uh, on the, on the radio site today, as well as, as well as Birch benders.So, um, we do have some experience and, uh, in that area, but not for the, the, the main, the main products, the main products are on only in stores. Uh, the majority. Yes. Okay, cool. All right. I, I think we covered it. It's one o'clock we don't wanna take up too much of your time. It's been a busy day. We've we we've been on with Todd Lockman, the CEO of Sovos brands, ticker, S O V L IPO, like for an hour ago, actually.Um, so, uh, yeah, Todd, thanks so much for, uh, taking time out of your day to, to hop on that. And you can get to ring the bell today. Yeah, we do. We do. Awesome. All right. We'll be watching. We'll be watching. Hey, great to meet you both. You as well? Uh, that was fun, Spencer. Um, I'm hungry, man. As I know, we went straight from ice cream to more delicious food.It's like, what are we, what are we doing right at lunchtime to, oh my gosh. Yes. I'm Hong it's one. O'clock let's go eat everyone. Uh, grab some food and come back to, uh, get technical with you're starting live right now. AB I think, uh, can we get, uh, I think we'll get Neil going and if you haven't already guys drop us.How many likes are we at? Let's find out not enough, not enough. And I'll tell you that much or at wait a minute. Wait a minute. Wait a minute. We're at 52 50. Oh guys. Come on. Four interviews today, three public company execs, one IPO and a Partridge in a pear tree. We did it all for you today. So at least get us to a hundred and.Th th that, that that'll be, that'll be that I spent, I'm going to hop out and get Neil started. I will see you when I see ya. Okay. AB was see over on gay telling all this stream will end. It'll redirect you automatically to get technical. That's how we do things here on Vincent. Any feedback, questions, comments, concerns shows admin zynga.com.Email us, check out Benzinga events.com. To see all of our future events from our, our healthcare conference next week to cannabis next month to, uh, everything. All right. That's a wrap for me here. Hit the, like us here, you guys over on getting technical with, uh, wacky Neil Hamilton. Um,Support this podcast at — https://redcircle.com/zingernation-power-hour/exclusive-contentAdvertising Inquiries: https://redcircle.com/brandsPrivacy & Opt-Out: https://redcircle.com/privacy

Returning guest, Dr. Bruce Sands, M.D., M.S., Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Hospital and the Dr. Burrill B. Crohn Professor of Medicine (Gastroenterology), at the Icahn Institute for Medicine at Mount Sinai discusses new data presented at the 16th Congress of European Crohn's and Colitis Organisation (ECCO) from a trial evaluating biologic induction and maintenance therapy for moderately to severely active ulcerative colitis. #ECCO2021 #UlcerativeColitis Bruce E. Sands, M.D., M.S., Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Hospital and the Dr. Burrill B. Crohn Professor of Medicine (Gastroenterology), at the Icahn Institute for Medicine at Mount Sinai is the study spokesperson for the three-year data from the long-term extension (LTE) of UNIFI, a Phase 3 protocol designed to evaluate the safety and efficacy of STELARA induction and maintenance dosing for the treatment of moderately to severely active ulcerative colitis in adults who demonstrated an inadequate response to or were unable to tolerate conventional (e.g., corticosteroids, immunomodulators) or biologic (e.g., one or more TNF blockers or vedolizumab) therapies. Dr. Sands' clinical research includes treating inflammatory bowel disease and clinical investigations of new therapeutics. He serves as a reviewer for the New England Journal of Medicine and is a fellow of the American College of Gastroenterology and the American Gastroenterological Association.

Returning guest, Dr. Andrew Greenspan, Vice President of Immunology Medical Affairs at Janssen discusses recent data from the Phase 3b SEAVUE study, the first head-to-head study of biologic therapies in patients with Crohn's disease, evaluating the safety and efficacy of STELARA® (ustekinumab) compared with adalimumab through one year of treatment in biologic-naïve patients. These data were presented at this year's Digestive Disease Week (DDW) Virtual 2021, where Janssen Immunology presented 20 abstracts in total from the company's gastroenterology portfolio and pipeline. As Vice President of Immunology Medical Affairs, Andrew Greenspan, M.D., is responsible for leadership and oversight of Immunology Medical Affairs activities supporting REMICADE® (infliximab), SIMPONI® (golimumab), SIMPONI ARIA® (golimumab for infusion), STELARA® (ustekinumab) and TREMFYA® (guselkumab) for a wide range of diseases, including rheumatoid arthritis, Crohn's disease, ulcerative colitis and psoriasis. #Immunology #CrohnsDisease #IBD

Returning guest, Dr. William Sandborn, MD, Chief of Gastroenterology, Professor of Medicine, University of California, San Diego, discusses positive study results in Crohn's disease from the IM-UNITI trial on STELARA'S efficacy at five years and the TREMFYA GALAXI-1 trial, Phase 2, week 12 Interim Analyses Data. The GALAXI abstract has been recognized among the three highest scoring UEGW (United European Gastroenterology Week) 2020 abstracts in one of the main categories.

Returning guest, Dr. William Sandborn, Chief of the Division of Gastroenterology at UC San Diego Health, discusses recent data from the Phase 3 UNIFI study evaluating the safety and efficacy of Janssen's STELARA® (ustekinumab) as a maintenance therapy in patients with moderately to severely active ulcerative colitis who previously failed biologic or conventional therapy. The long-term extension study out to two years, includes an abstract showing the effect of treatment on stool frequency and rectal bleeding. These data were presented at the 2020 American College of Gastroenterology (ACG) Annual Meeting.

In today’s episode, Bec Simpson shares her journey with Crohn’s Disease and how she balances life, competitive sports, work, and family. Her journey began almost a decade ago when she struggled with symptoms that she thought were due to IBS, which was common in her family. But in 2011, after running out from the class she was teaching with an urgent need for the restroom, she knew she needed to see a gastroenterologist.  Her initial colonoscopy, however, didn’t show anything and she continued to struggle and manage her symptoms for another five years. Finally in 2016, she had another colonoscopy and Crohn’s Disease was confirmed. After that, she quickly went through a number of medications, from Prednisone, Pentasa, Methotrexate, and Humira (from which she suffered side effects) to now, finally seeing results after just one infusion of Stelara. Bec shares what it was like to go through the different medications and how grateful she is to have a gastroenterologist who provided her with a lot of information, but ultimately left the decision up to her.  During all this time, Bec continued (and still does) to play competitive sports. She plays in the Touch Rugby League in Australia and has learned to balance her passion for fitness and rugby while managing IBD. Realizing that she was able to get away with pushing her body harder and past its limits when she was younger, she knows now that rest and listening to her body is key for staying healthy and managing symptoms. She’s also learned to change her mindset and rather than getting upset at the limitations Crohn’s may have placed on her, she focuses on doing the best she can and being grateful for that.  Outside of sports, Bec relies on her strong support network, made up of her family and partner, that allows her to balance life and continue with her passions. Recently, her gastroenterologist also sent her to see a psychologist who works with patients with chronic illnesses. While simply being able to talk and vent about the disease was beneficial, the psychologist also gave Bec a number of different strategies to help manage stress in her life, which is the main trigger for her symptoms and flare ups, including mindfulness and not being afraid to take a step back to rest.  Bec is now sharing her journey with Crohn’s on social media and raising awareness. She encourages others who are also fighting IBD to take it easy – still work hard to achieve your goals, she says, but listen to your body. You can follow her on Instagram at @becs_ibd_journey. 

In today’s episode, we continue Nicole Candelaria’s story from her decision to begin traveling to and from New York to see a gastroenterologist who specializes in IBD. Everything happened quickly as her new doctor was determined to not let her suffer any longer, but she quickly became weary of the travel and the reluctance of her doctors in Florida to cooperate.  In New York, however, her doctor blew her away with the amount of information she knew about IBD and her willingness to explain and discuss in detail the answers to many of Nicole’s questions that her doctors in Florida were never able to give. From medications to surgical options, her new doctor shared the reasoning behind every step of her treatment plan.  This past fall, Nicole went on short-term disability and began seeing her doctor in New York once a week. As she began healing, her visits dropped to every other week and then every few weeks. Using Methotrexate to help her transition from Remicade to Stelara, Nicole and her doctor finally started to see an improvement just this past February.  It was then, after all the years battling IBD and only achieving remission for one brief period, Nicole finally had hope and she realized that in order to get better she needed to move to New York to be able to continue this journey with her new doctor. As the timing worked out, she was able to move and get settled into a place in New Jersey just before the Coronavirus pandemic hit the U.S. in March.  Today, Nicole is vibrant, energetic, and thriving. Looking back, she realizes what a shell of her former self she had become – not realizing she was simply going through the motions day in and day out. Now, she’s happy, appreciating every moment of life, and sharing her story with the IBD community. One of her biggest struggles throughout her journey, with all the highs and lows that IBD brings, was body image. Nicole often found herself hating her body for fighting against her, she was uncomfortable, and had no self love. Over the years, however, she gained a different outlook. Her experiences with IBD, she said, were humbling and she learned to love and be grateful for her body and everything it was doing to fight FOR her. With that new perspective, she created her Instagram handle, @crohnsically_beautiful, and began sharing her journey to help provide comfort and show others that they are not alone.  To those who are newly diagnosed, Nicole gives a reminder that you will get through it, you’re not alone. For those who are currently battling flare ups, “you’ve got this!” And for family members, she shares the importance of reading up and becoming as informed as possible to help better understand the person in your life with IBD. ---- Follow Nicole: www.instagram.com/crohnsically_beautiful

Cory Rubin is a Board-Certified Dermatologist practicing at the Michigan Dermatology Institute in Waterford, Michigan. He is the founder and medical director of the practice, and is on staff with several large health systems in Michigan including Ascension/St John-Providence, Beaumont-Royal Oak, DMC Huron Valley-Sinai, McLaren-Oakland and St Joseph-Oakland hospitals. His medical school education was completed at Thomas Jefferson University in Philadelphia and his dermatology residency training was performed at the University of Michigan in Ann Arbor. He has a passion for complex medical dermatology and professional skin care. When not practicing, he is a proud father, happy husband and avid ice hockey player. Instagram links https://www.instagram.com/@208SkinDoc https://www.instagram.com/@treasurevalleyderm https://www.instagram.com/@michiganderminstitute If you think you may have psoriasis and would like to seek out a dermatologist in your area please visit https://find-a-derm.aad.org/ to locate a board certified dermatologist in your area.  For additional resources for patients with psoriais please visit https://www.psoriasis.org/ or https://dermatologyboise.com/What-We-Treat/Psoriasis Oral medications discussed included methotrexate as well as Otezla https://www.otezla.com/ The biologic injectable medications we discussed are listed here as well according to their class, and otherwise in no particular order.  TNF-inhibitors Humira https://www.humira.com/ Enbrel https://www.enbrel.com/ Cimzia https://www.cimzia.com/ Remicade https://www.remicade.com/ IL-17 inhibitors/receptor blockers Cosentyx https://www.cosentyx.com/ Taltz https://www.taltz.com/ Siliq https://www.siliq.com/ IL-23 inhibitors Ilumya https://www.ilumya.com/ Tremfya https://www.tremfya.com/ Skyrizi https://www.skyrizi.com/ IL-12/23 inhibitor Stelara https://www.stelarainfo.com/ If you have found this information helpful please consider leaving us a 5-star review on Apple Podcasts or wherever you get your podcasts.

Dr. Jan Wehkamp, M.D. Vice President and Gastroenterology Disease Area Leader for the Immunology Therapeutic Area at Janssen Research & Development, LLC, talks about data from the Phase 3b, STARDUST study, showing that two doses of STELARA® (ustekinumab) induced clinical remission in two-thirds of patients with Crohn’s Disease (CD). STARDUST is the first study to compare a treat to target approach with standard of care in CD and using endoscopy to guide use of medication.

People who live with Crohn’s disease or ulcerative colitis have more to consider when it comes to the workplace. The cost of inflammatory bowel disease (IBD) means that a comprehensive insurance plan is a must, which may limit job choices. A flare-up or complication that results in absences can lead to poor performance reviews or difficulties with supervisors or co-workers. How can people with IBD cope? Three women who live with IBD, Megan Starshak, Mary Elizabeth Ulliman, and Tina Aswani Omprakash, tell their stories about missing work, being underinsured, and changing jobs while managing IBD. Information discussed in this episode includes Clostridium difficile (C diff), pouchitis, Crohn’s and Colitis Foundation Help Center, IBD and the Americans With Disabilities Act, The Family and Medical Leave Act, and Financial Help for People with IBD. Select pharmaceutical company assistance programs: Cimzia (certolizumab Entyvio (vedolizumab Humira (adalimumab Inflectra (infliximab biosimilar Remicade (infliximab) Renflexis (Infliximab biosimilar Simponi (goliumumab Stelara (ustekinumab Tysabri (natalizumab Xeljanz (tofacitinib Find Megan Starshak on MeganStarshak.com, Twitter, and Instagram. Find Tina Aswani Omprakash on Own Your Crohn’s, Facebook, Twitter, and Instagram. Find Mary Elizabeth Ulliman on Instagram. Find The Great Bowel Movement on Facebook, Twitter, and Instagram. Find Amber J Tresca at AboutIBD.com, Verywell, Facebook, Twitter, Pinterest, and Instagram. Credits: Sound engineering courtesy Mac Cooney. "IBD Dance Party" ©Cooney Studio.

In today’s episode, Stella Rose Carr shares how she’s managed to keep a positive outlook and a good sense of humor while battling Crohn’s Disease for most of her life. Officially diagnosed at eight years old, she recalls what it was like to face her first colonoscopy as a child and how IBD impacted her life from elementary school through college. At 13 years old, she had six inches of her small intestine removed. While things did improve after that, she still found herself sick often from a compromised immune system. Stella opens up and talks about her recent decision to come off of the Humira she was taking in order to try different medications that could offer less frequent injections. Her body struggled for about a year when she switched from Humira to Stelara and she eventually went back to Humira, without the same relief as before, and is now hoping to find remission with Entivyo. Still battling flare ups and symptoms, Stella shares how she’s been able to keep both her sense of humor and overall positive outlook while battling Crohn’s. She gives a lot of credit to The Painted Turtle–a camp for kids with serious medical conditions–and how the opportunity to attend helped her build her confidence and made her comfortable talking about her disease and how to explain it to others. Though she’s always been active, Stella talks about how the role of fitness has evolved in her IBD journey. When Crohn’s prevents her from giving 100%, she incorporates meditative bodywork, breathing, and low-intensity activities like hiking, yoga, or just stretching into her days when her body is run down. She also shares her tips and the importance of communicating your disease needs with your supervisor or co-workers and how she focuses on making it through flare ups. Stella’s advocacy for IBD began when she was just a child. While attending The Painted Turtle helped her practice explaining what IBD is to other people, she used opportunities like her elementary school science projects and high school projects to talk about Crohn’s Disease and Ulcerative Colitis. During high school, she was also recognized as the Honored Hero for her local Take Steps walk. Today, she continues talking about IBD using social media and online platforms to share both general information and her own personal story and what daily life is like with Crohn’s. Keep up with Stella at:www.instagram.com/stellar.carr @stellar.carrwww.stellasays.mePodcast: Trust me I’m funny -------------------- Intestinal Fortitude Supplements: https://www.crohnsfitnessfood.com/if (10% OFF use code CFF10)Cellercise Rebounder: https://www.crohnsfitnessfood.com/cellercise ($80 Bonus Coupon Holiday Special)

Lead study investigator Dr. Bruce Sands, Icahn School of Medicine, Mt. Sinai, New York discusses Janssen's announcement of their new two-year data from the long-term extension of the Phase 3 UNIFI study of STELARA® (ustekinumab) that demonstrated long term efficacy and safety in adult patients with moderate to severe ulcerative colitis. This was presented as late-breaking data at the 27th United European Gastroenterology Week (UEGW) congress.

Here are the links for everything discussed in Episode 8. New Drug approval for Cystic Fibrosis - Trikafta Approval of Amzeeq Additional indication for Farxiga Stelara wins a new indication from the FDA USP delays new revisions Connect with The Rx Daily Dose:Twitter      Instagram      YouTube      Linkedin       WebsiteEmail: therxdailydose@gmail.comConnect with Ian Parnigoni PharmD. on social media:Twitter       Instagram       Linkedin  ★ Support this podcast on Patreon ★

Today’s guest is Natalie Suppes, who was diagnosed with Crohn’s Disease in 2007 and, after a 12-year flare, is finally in remission. She is a certified personal trainer and sport nutritionist who is passionate about helping women (especially those whose bodies are not functioning!) become the healthiest versions of themselves. In this episode, she shares her story with IBD and why it’s so important to take care of your body and do your best to nourish and move it in a way that helps you heal. Diagnosed in 2007, Natalie was in a constant flare for 12 years. She tried a number of different medications from steroids and Imuran to Humira and Stelara. In 2017, she experienced a perforated bowel that was able to heal from the use of biologic medications; however, it resulted in significant weight gain. She turned her focus to diet and exercise. Following a ketogenic-style diet, using intermittent fasting, and experimenting with supplements, she started to turn her health around. During her struggles with weight and success in reclaiming her health, she started coaching other women with Crohn’s and Colitis and helping them achieve better health. Natalie shares her passion and the journey of developing the IBD Break Free Academy and how she became known as The Crohn’s Coach. She encourages all IBD Warriors to find practices that can bring you back to a positive mindset during the day and to focus on the things you enjoy that you have control over, that your disease won’t stop. IBD Break Free AcademyNext session runs May 8 - June 26, 2019 Register before April 308-week group coaching to help women focus on nutrition, mindset and movement for better health.https://www.forthehealth.ca/ibdbreakfreeacademy Facebook Group:https://www.facebook.com/groups/198951584114128/ Crohn’s & Colitis “Unbreakable” Hoodies and Tanks:https://www.bonfire.com/forthehealth/ Follow Natalie:https://www.forthehealth.ca/https://www.instagram.com/for.the.health/

Dr. William Sandborn, University of California San Diego, discusses his presentation of the pivotal phase 3 data for STELARA® (ustekinumab) as maintenance therapy in patients with moderate to severe ulcerative colitis (UC), at the European Crohn’s & Colitis Organisation Annual Meeting (ECCO) 2019. Visit www.hpr.fm to listen to more interviews about healthcare and research findings.

Today’s guest is Elizabeth Alvarez, also known as The Dancing Crohnie. Elizabeth was diagnosed with Crohn’s disease in 2011 at the age of 21. Since then, she’s described her journey as one wild ride trying to attain remission.  She’s been on numerous medications–including included Remicade, Entyvio, Humira, Stelara, Prednisone, Dilaudid, Valium and many others–and is now pairing conventional medicine with non-conventional treatments and organic lifestyle changes. Elizabeth shares her journey in pursuing a career in professional dancing, how she gave it all up when she experienced the worst flare of her life, and how she’s regaining her health and finding her way back to dancing. She relies on the expertise of her Gastroenterologist, her Naturopathic Physician, and a Dietitian to help guide her in her healing journey. In this episode, we talk about the importance of diet–including suggestions for cutting out known inflammatory foods like dairy, gluten and sugar–and her latest addition to her nutritional protocol: celery juice. (http://www.medicalmedium.com/blog/celery-juice) She urges every IBD patient to learn how nutrition can play a role in IBD management and encourages everyone to be an advocate for their own health. Follow Elizabeth online: BLOG: www.thedancingcrohnie.comCheck out her blog for articles, tips, and tricks for navigating everyday life with Crohn’s and Colitis. SOCIAL MEDIAInstagram @thedancingcrohnieFacebook: https://www.facebook.com/The-Dancing-Crohnie-517797962006260/

Is it possible to take the diagnosis that turned your world upside down and turn it into a positive force in your life? My guest on About IBD is Lilly Stairs, Head of Patient Advocacy at Clara Health who lives with Crohn’s disease did exactly that. First diagnosed with psoriatic arthritis, it was only after Lilly’s symptoms weren’t improving and she was in and out of the hospital that healthcare providers finally discovered a Crohn’s disease flare-up in her small bowel. Lilly found the right mix of treatments to get her Crohn’s under control and now works with her team at Clara to connect patients to clinical trials.    Find Lilly Stairs at Blog: https://www.lillystairs.com/ Twitter: https://twitter.com/LillyStairs Instagram: https://www.instagram.com/lillyrosestairs/ LinkedIn: https://www.linkedin.com/in/lillystairs/ Facebook: https://www.facebook.com/lilly.stairs.56   Find Clara Health at: Twitter: https://twitter.com/Clara_Health Instagram: https://www.instagram.com/clarahealth/ LinkedIn: https://www.linkedin.com/company/clara-health Facebook: https://www.facebook.com/clarahealth Patients Have Power Podcast: https://itunes.apple.com/us/podcast/patients-have-power/id1321097377?mt=2   "About IBD with Amber Tresca" © Cooney Studio http://cooneystudio.com/

This week, Daniel and Dillon watch a commercial for Stelara, a pharmaceutical that supposedly combats the symptoms of Crohn's disease. Join us as we talk about the manipulative effects of music and cinematography, the crafting of a narrative designed for people who are suffering, and the internal negotiations that a person with chronic illness has to make daily. And of course, by extension, we examine the hour long list of side effects you always see in these pharma commercials. Follow us on Twitter: @PopUpThePodcast Shoot us an email! PopUpThePodcast@gmail.com Support the show: www.patreon.com/dillonwall Don't forget to subscribe on iTunes, or wherever you get your podcasts. And if you share the show with your friends, you'll be our absolute favorite person.

Is this thing on?! It’s been a month since the last episode of the Ali on the Run Show, but I am so happy to be back. On this episode, I’m sharing where I’ve been, what’s been going on, and how I’ve been feeling throughout my latest Crohn’s disease flare. I also talk about the one thing I’ve been doing differently lately that I *think* may have to do with why I’ve started feeling better, and I talk about why I decided to take a social media break (which I highly recommend, by the way). It’s good to be back! Stuff I Mention on this Episode: Ali on the Run Show Episode 30: My Crohn’s Disease Story: http://www.aliontherunblog.com/2017/05/23/ali-on-the-run-show-episode-30-my-crohns-disease-story/ Ali on the Run Show Episode 32: Crohn’s Disease Q&A: http://www.aliontherunblog.com/2017/05/30/ali-run-show-episode-32-crohns-disease-qa/ Ali on the Run Show Episode 2: Being Married to Someone With Crohn’s Disease: http://www.aliontherunblog.com/2017/03/01/episode-2-brian-cristiano-married-someone-crohns-disease/ An update on the Crohn’s situation: http://www.aliontherunblog.com/2017/06/20/crohns-update/ Stelara: https://www.stelarainfo.com/ Prime Cycle: http://primecycle.com/ Orangetheory: https://www.orangetheoryfitness.com/ Headspace: https://www.headspace.com/ Parsley Health: https://www.parsleyhealth.com/ Ali on the Run Show Episode 27 with Meggie Smith: http://www.aliontherunblog.com/2017/05/11/ali-run-show-episode-27-meggie-smith-md-chief-resident-ob-gyn-nyu-langone-medical-center/ My experience with InsideTracker: http://www.aliontherunblog.com/2017/04/10/advocate-broken-system-tried-insidetracker/ InsideTracker: https://www.insidetracker.com/ Follow Ali: Instagram @aliontherun1: https://www.instagram.com/aliontherun1 Facebook: https://www.facebook.com/aliontherun/ Twitter @aliontherun1: https://twitter.com/aliontherun1 Blog: http://www.aliontherunblog.com/ Strava: https://www.strava.com/athletes/13333410 Thank you for listening to and supporting the Ali on the Run Show! If you’re enjoying the show, please subscribe and leave a rating and review on iTunes. Spread the run love!