Podcasts about imbruvica

In this episode, Danielle M. Brander, MD; Deborah Stephens, DO; and Brian Hill, MD, PhD, discuss key aspects of the NCCN CLL guidelines and share strategies for applying these recommendations in your clinical practice to optimize treatment and outcomes. The greater discussion addresses:Optimal selection of therapy for treatment-naive CLL, including second-generation covalent BTK inhibitorsConsiderations in therapy selection for previously treated CLLNovel strategies for treating CLL Presenters:Danielle M. Brander, MDAssistant Professor of MedicineDivision of Hematologic Malignancies and Cellular TherapyDuke Cancer InstituteDurham, North CarolinaBrian Hill, MD, PhDDirector, Lymphoid Malignancies ProgramStaff Physician, Department of Hematology and Medical OncologyTaussig Cancer InstituteCleveland ClinicCleveland, OhioDeborah Stephens, DOAssociate ProfessorDirector of the CLL ProgramLineberger Comprehensive Cancer CenterUniversity of North CarolinaChapel Hill, North CarolinaContent based on a live and online CME program supported by educational grants from AstraZeneca; BeiGene, Ltd.; and Lilly.Link to full program including downloadable slides: https://bit.ly/49YxtSq

Visit nascentmc.com/podcast for full show notes Visit learnamastyle.com for the free course on ChatGPT4 for medical writers and editors.  - The FDA has approved amivantamab (Rybrevant) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. This approval converts the May 2021 accelerated approval of amivantamab to full approval. - The FDA approved the AGENT Drug-Coated Balloon (DCB) for treating in-stent restenosis in coronary artery disease patients, introducing the first drug-coated coronary balloon in the US. It uses a paclitaxel-coated catheter to deliver medication directly to the vessel wall, offering an alternative to traditional treatments and aiming to reduce recurrence risks. The approval was based on the AGENT IDE trial, demonstrating its effectiveness over uncoated balloon angioplasty in reducing lesion failure, with no significant adverse events reported. - The FDA approved an oral suspension form of ibrutinib (Imbruvica) for several conditions, including chronic lymphocytic leukemia and chronic graft versus host disease, addressing the needs of patients who have difficulty swallowing pills. This is the first oral suspension formulation of a Bruton's tyrosine kinase inhibitor, originally approved in 2013 for mantle cell lymphoma. The approval, granted to Johnson & Johnson and Pharmacyclics, aims to simplify treatment for patients challenged with pill-swallowing. - Epcoritamab-bysp (Epkinly) received FDA approval for treating adult patients with relapsed or refractory follicular lymphoma after at least two prior therapies, marking it as the first subcutaneously administered bispecific antibody for this condition. It works by targeting both CD3 on T cells and CD20 on B cells to induce cell death. Based on the EPCORE NHL-1 trial results, this approval extends its use beyond diffuse large B-cell lymphoma, with AbbVie and Genmab sharing commercial responsibilities.  - The FDA granted priority review to the New Drug Application for govorestat (AT-007), a treatment for classic galactosemia, potentially the first of its kind if approved. Govorestat, an aldose reductase inhibitor, aims to reduce harmful galactitol levels, based on phase 3 study results among pediatric patients. Applied Therapeutics announced a PDUFA target action date of August 28, 2024, highlighting the urgent need for treatments in this area. - Obeticholic acid (Ocaliva) received FDA consideration for an expanded application to treat primary biliary cholangitis, building on its 2016 accelerated approval. It's designed for patients with or without cirrhosis, showing promise in post-marketing studies to confirm its clinical benefits. The review includes data from various studies and real-world evidence, with a PDUFA target date of October 15, 2024, aiming to address the needs of this autoimmune liver disease population.  - The FDA approved Biktarvy for HIV patients with suppressed viral loads who exhibit M184V/I resistance, offering a new treatment option for those with specific resistance mutations. Biktarvy combines three therapies in a single tablet, based on successful 48-week study data. Manufactured by Gilead Sciences, this approval expands treatment possibilities for patients facing resistance challenges. - The FDA rejected Minerva Neurosciences' New Drug Application for roluperidone as a treatment for schizophrenia's negative symptoms, citing insufficient evidence from a single study and lack of comprehensive data. Despite showing promise in targeting specific brain receptors, the FDA's concerns highlight the need for more extensive research and data to confirm its effectiveness and safety. Minerva plans to engage with the FDA to address these issues.

This past weekend, the CURE® staff was busy covering the American Society of Hematology (ASH) Annual Meeting. ASH is the largest blood cancer conference in the country, and thousands of abstracts were presented. Now, we're bringing you some of the highlights from the conference. And, to view all of our conference coverage, be sure to check out curetoday.com/conference Navitoclax Plus Jakafi Improves Spleen Volume Reductions in Myelofibrosis Spleen enlargement is a common and often problematic symptom of myelifbrosis. However, recent findings from the phase 3 TRANSFORM-1 trial found that combining the novel drug, navitoclax with Jakafi was successful in reducing spleen volume in this patient population. The main outcome that the researchers were looking at in this study was the percentage of patients who had a spleen volume reduction of 35% or more at certain time points. Findings showed that by week 24, 64.2% of patients who had the navitoclax regimen experienced this level of spleen reduction, compared to only 31.5% of patients who received placebo plus Jakafi — that's a significant overall difference of 31%. Navitoclax is not currently approved in any indication, but AbbVie, the pharmaceutical company behind the agent, plans to submit the drug for FDA approval in 2023, pending study results. Brukinsa Lengthens Time to Progression in Relapsed/Refractory CLL, SLL There are currently three BTK inhibitors for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL and SLL, respectively), though a lack of research exists that compares these drugs head-to-head. Now, the phase 3 ALPINE trial was the first study to directly compare two BTK inhibitors, Brukinsa and Imbruvica, in patients with relapsed or refractory CLL or SLL. Findings showed that after about 39 months of follow-up, patients given Brukinsa tended to live longer before death or disease progression — a statistic experts refer to as “progression-free survival.” In the general patient population, Brukinsa reduced the risk of disease progression by 32%, and for patients with 17p deletion and/or TP53 mutations — subtypes that typically indicate aggressive disease — there was a 48% reduction in the risk of disease progression. Abecma May Improve Quality of Life in Previously Treated Myeloma The phase 3 KarMMA-3 trial showed that Abecma significantly improved symptoms, functioning and health-related quality of life in patients with relapsed or refractory multiple myeloma who previously underwent two to four prior treatments. Abecma is a CAR-T cell therapy, which is a newer type of treatment for blood cancers. It involves taking patients' blood out, and re-engineering their T cells to find and fight cancer. After they're multiplied, those new T cells are infused back into the patient. Findings from the KarMMA-3 trial showed that Abecma led to improvements in fatigue and pain compared with other standard regimens in this patient population.

Synopsis: Brett Hall, Ph.D., is the CSO of Immuneering, a public, clinical-stage oncology company dedicated to developing medicines for broad populations of cancer patients by applying its deep knowledge of translational bioinformatics to every stage of the drug development process. Brett talks about his background in the military targeting nuclear missiles prior to becoming a scientist and some of the commonalities between working in the military and pharma/biotech. He shares his thoughts on AI and machine learning in drug development. He talks about Immuneering's disease-agnostic platform that enables the company to utilize human data, novel biology and chemistry, and translational planning to create and advance its pipeline. Finally, he discusses their focus on oncology and providing potential treatments for patients with advanced solid tumors. Biography: Brett Hall, Ph.D. has served as Chief Scientific Officer of Immuneering since November 2019. He also served as the Founder and Chairman of the board of directors of BioArkive, Inc., or BioArkive, a privately held biotechnology services company from January 2019 until December 2021. Prior to joining Imuneering, Dr. Hall served as the Chief Executive Officer of Asellus Therapeutics, LLC from July 2015 until May 2018. Dr. Hall served in roles of increasing responsibility with Johnson & Johnson from November 2008 until July 2014, culminating in his role as the Head of Biomarkers of the Hematologic Disease Area Stronghold, where he led translational efforts for Sylvant® and Imbruvica® through clinical development. Subsequently, he served as the Head of Translational Medicine of Oncology at Medimmune, LLC, the biologics division of AstraZeneca Pharmaceuticals LP, from July 2014 until July 2015, before transitioning to executive discovery roles in biotechnology. He has extensive drug development and leadership experience ranging from early drug discovery through translational clinical sciences, including multiple drug registrations. Dr. Hall has extensively published in the areas of tumor microenvironment (TME) and translational sciences, and holds multiple patents for drug pharmacology and discovery. He was also a tenure-track Assistant Professor at Ohio State University where his laboratory focused on the development of human TME-aligned models to better translate preclinical data into the clinic and discover novel biomarkers. Prior to Dr. Hall's career in life sciences, he served in the United States Air Force and worked as an investment banker. Dr. Hall received his B.S. in biochemistry from Ohio State University, his Ph.D. in immunology and cancer biology from West Virginia University, and completed his post-doctoral fellowship in cancer cell epigenetics at St. Jude Children's Research Hospital.

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

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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Implantable device approved for those with knee osteoarthritis; Prescribing Information labeling updated for opioids; Imbruvica indications withdrawn; Patch to combat excessive underarm sweating given green light; Novel treatment Fast Tracked for Type A and B influenza.

In today's episode, Keith Reid-Cleveland, an editor at Morningstar Inc., discusses Morningstar's research on the racial wealth gap and a proposal to help close it known as baby bonds.Timestamps00:06 Introduction00:36 Disney CEO Bob Iger Plans to Cut Billions01:49 Uber's Total Revenue Soars02:39 PayPal Faces Tough Environment03:34 AbbVie's Long-Term Outlook04:36 America's Racial Wealth Gap and How to Shrink It04:59 What has research shown about wage disparities when households are compared? 05:49 How are savings rates affected? 06:29 What's the impact on building a nest egg? 06:59 What are some thoughts on building financial security through homeownership? 08:00 How could baby bonds help close the racial wealth gap? 09:15 6 IRA Mistakes to Avoid    Read about topics from this episode.Disney Reports Decent Earnings With Iger Already Reapplying His StampUber Reports Impressive Q4; Strong 2023 Growth ExpectedPayPal Remains a Unique Player in PaymentsAbbVie Posts Solid Q4, but Competitive Pressures to Limit Long-Term Growth11 Charts Examining Racial Wealth Gap What to watch from Morningstar.Could Meta Make a Comeback?How Secure Act 2.0 Changes RMD RulesShould You Buy a House Right Now?Big Banks Bracing for a Recession   Read what our team is writing:Keith Reid-ClevelandChristine BenzSusan DziubinskiFollow us on social media.Ivanna Hampton on Twitter: @IvannaHampton Christine Benz on Twitter: @Christine_Benz Facebook: https://www.facebook.com/MorningstarInc/  Twitter: https://twitter.com/MorningstarInc  Instagram: https://www.instagram.com/morningstar...  LinkedIn: https://www.linkedin.com/company/5161/ 

Journalist Nathan Vardi joins us to talk about his new book delving into the race to develop the lifesaving cancer drug now called Imbruvica, involving a Scientologist CEO and secretive investor seeking redemption after the worst trade of his life. We also discuss the latest news in the life sciences, including new vaccines for a vexing infection and the future of mRNA.

Listen to a soundcast of the 8/24/22 and 8/26/22 FDA approvals of Imbruvica (ibrutinib) for pediatric patients with chronic graft versus host disease, including a new oral suspension, and Pemazyre (pemigatinib) for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement.”

Dr. Corey Cutler is the medical director of the Stem Cell Transplantation Program at Boston's Dana Farber Cancer Institute and an associate professor of medicine at Harvard Medical School.  As a physician at the forefront of cancer research, he talks about how the field has rapidly advanced, thanks to the volunteers who participate in clinical trials.Dr. Cutler's field of expertise is Graft Versus Host Disease, and he starts by walking through all the different therapies that have come out of clinical trials, including Imbruvica, Jakafi, Rezurock and Abatacept.In this episode, we also take on common myths around clinical trials, including patients who are concerned about placebo, and how they also benefit from the trials. Any clinical trial participant should put their own health first, ahead of any altruistic intentions.  And not all trials involve new therapies. You can participate in a cohort study, which only follows your existing plan for research purposes.Most importantly, all participation in clinical trials is 100% voluntary.  Patients may remove their consent at any time in the process, and all trials are strictly monitored by independent review boards who place a priority on patient safety.While Dr. Cutler's focus is on GVHD, he also speaks to the many advances in the fields of leukemia, lymphoma, and more, thanks to the progress made by clinical trials.More:US Clinical Trials Website: https://clinicaltrials.gov/National Bone Marrow Transplant Link - (800) LINK-BMT, or (800) 546-5268.nbmtLINK Website: https://www.nbmtlink.org/nbmtLINK Facebook Page:  https://www.facebook.com/nbmtLINKnbmtLINK YouTube Page can be found by clicking here.Thank you to this season's sponsors:Omeros Corporation: https://www.omeros.com/Incyte: https://www.incyte.com/If you're curious about a clinical trial, you should ask your treating physician or center, or visit the government's central registry of all clinical trials at https://clinicaltrials.gov/

In this episode, Ayesha discussed Fitbit's new lineup of smartwatches that is set to release this fall, including the Sense 2 which has a sensor for the detection of atrial fibrillation (AFib). Fitbit said the Sense 2 is its most advanced health-focused smartwatch to date. The device has a sensor that can identify signs of AFib through the company's electrocardiogram (ECG) app and photoplethysmography (PPG) algorithm. Hear more about the AFib detection feature as well as the smartwatch's new Body Response sensor for stress management. Ayesha also discussed the FDA approval of Imbruvica (ibrutinib) for pediatric patients one year of age and older with chronic graft-versus-host disease (cGVHD). This is the BTK inhibitor's first approval for a pediatric indication, and the first approved liquid form of the drug. The approval addresses an unmeet need in this indication, as treatment options for cGVHD in younger children are limited. Learn more about the approval in this episode of the Xtalks Life Science Podcast.Read the full articles here:Fitbit Sense 2 Smartwatch with AFib Detection to Launch This FallImbruvica Wins Milestone Approval for Children as Young as 1 With Chronic GVHDFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

David Dahan, Ellie Davenport, Tom Tyler and Zachary McLellan discuss the 2021 ASCO conference. Topics covered include: CheckMate 648 trial, Opdivo in Esophageal Cancer - 00:47 VISION trial, 177Lu-PSMA-617 in Prostate Cancer – 08:20 RELATIVTY-047 trial, Relatlimab and Opdivo in Melanoma – 15:36 CARTITUDE-1 trial, Cilta-cel in Multiple Myeloma – 19:45 ELEVATE-RR trial, Calquence vs. Imbruvica in Chronic Lymphocytic Leukemia – 26:01

In this episode of the “CURE Talks Cancer” podcast, we spoke with Mark Hoffman, a patient with chronic lymphocytic leukemia (CLL), about his diagnosis and treatment journey.   Mark Hoffman, 53, a tech salesman in San Diego, started to experience swollen lymph nodes that weren’t going away. He finally sought a specialist who did a lymph node biopsy, determining Mark had CLL.   Mark has a 17p deletion in addition to other high-risk genetic markers. At first, he was under watch and wait for his disease, but his white blood cell count peaked at 90,000 (the normal range is 4,500 to 11,000 per microliter). Luckily, in 2017, Mark began a clinical trial combining Imbruvica (ibrutinib) with Venclexta (venetoclax).

In this episode of the “CURE Talks Cancer” podcast, we spoke with r. Asher Chanan-Khan about current standards of care for Waldenstrom macroglobulinemia, also known as WM.    WM is a rare, incurable disease. Its current standards of care available consist of Rituxan (rituximab), Imbruvica (ibrutinib) combinations or monotherapy in the first- and second-line setting. However, there are no treatments currently approved for the third line.   Chanan-Khan discussed these options, as well as a novel agent, CLR 131, that is being evaluated in a phase 2 study. 

Here are the links for everything discussed in Episode 31, I'm also including times here so feel free to skip ahead to the topics that interest you. (1:05) Approval of Pemazyre for cholangiocarcinoma (5:00) New indication approval for Imbruvica (7:25) Trodelvy approved for triple negative breast cancer (11:25) CDC updates on COVID-19 & influenza reporting 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 ★

This episode will set the record straight regarding cGVHD. Most cases will subside in 3-5 years. You won't want to miss this one from one of the world's leading experts on cGVHD.Dr. Steve Pavletic is an incredible resource for folks with cGVHD. Dr. Pavletic leads a chronic GVHD clinic and natural history study at the National Institutes of Health. Learn more about cGVHD, treatment updates, and his incredible opportunity for those who qualify.Dr. Pavletic will also speak about steroids, the love/hate relationship many experience with them, and much more.Did you know that some cGVHD is actually good? You will want to hear more about this too.For additional resources from the National Bone Marrow Transplant Link, visit us online at nbmtlink.org or call us at 800-546-5268.This season of Marrow Masters is sponsored by the nbmtLINK, Seattle Genetics, and our esteemed link partners.

Dr. Fardis has extensive experience in drug development and novel cancer treatments. While at Iovance, the lifileucel (TIL for melanoma) has been transformed to a product which is in late stage development toward commercialization for metastatic melanoma. Prior to joining Iovance Biotherapeutics, Dr. Fardis was chief operating officer at Acerta Pharma working on the development of CALQUENCE® (acalabrutinib), until the company’s acquisition by AstraZeneca. Before joining Acerta, Dr. Fardis held the position of chief of oncology operations and alliances at Pharmacyclics where she oversaw development of IMBRUVICA® (ibrutinib). She was a key contributor in the creation of a broad clinical program for ibrutinib, as well as NDA and MAA submissions. Previously, Dr. Fardis held a number of key scientific and management roles at Gilead Sciences. At Gilead, she was involved with multiple therapeutic areas including antivirals, oncology, and cardiovascular therapeutics and worked on the development and life cycle management of LETAIRIS® (ambrisentan). She received her PhD in organic chemistry from UC Berkeley and holds an MBA.

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