POPULARITY
Wednesday, September 10, 2025. Week 37. CAMP4 Press Release: https://www.linkedin.com/posts/caleb-moore-4382704_syngap1-activity-7371545171047628800-zVqR Let me tell you a story: EW Story, concern over viability of C4. Easy to follow financials, Mrkt Cap and Net assets of ~$40M. Net income/EBITDA of -$12.6M in Q2. Running Phase I / II trials and ramping up for Phase III, not cheap. They need more than they had and capital is hard to get in this market. But here is the good part, the data is solid, the team is strong, and the SYNGAP1 Ecosystem is excited to have a first mover. SRF was thrilled to be invited, not just because we believe in C4, but because we wanted to send a meaningful signal to other investors that we are working closely with C4 and are eager to support their success. I believe that our investment, while modest, sent that signal and helped this raise become oversubscribed. The board worked hard on this one. Now for hard questions: Are we conflicted? No. We will transparently share info about all trials for products with good data. ( See #S10e172 for ASGCT Data https://youtu.be/9xO1TcO1Eus ) Will other companies be upset? Unlikely. Stoke and Praxis are the only companies publicly working on SYNGAP1 that are close to this point and they are not worried about financial viability, but if they do want to do a raise for their SYNGAP1 program, they should certainly call us. What will other companies think? Indeed we are de-risking the disease by showing that our kids are modifiable with ASOs which are the majority of the therapies in scope. This is a huge favor to others looking at this space. Isn't this taking a risk with our funds? Depends. But if it is, it's a risk worth taking. Remember we are the smallest investor, we only committed up to $1M, so other professional biotech investors put in $99M. What was the process? C4 came to us, we decided it was worth talking to the board who had multiple discussions but we said yes in less than a week and that was last week. When is the trial? 2H26 Less than a year from now. With this financing, I am sure of it. As I write this, the $CAMP stock closed up $0.80 or +40%. Which is solid. The market is starting to agree with the wise investors and SRF! Yes we need a cure. https://www.linkedin.com/posts/curesyngap1_savekramerdavis-activity-7371607032807763968-PVfG See you Friday: Beacon of Hope September 12, 2025 - Boston, MA cureSYNGAP1.org/Beacon25 SOCIAL MATTERS - 4,311 LinkedIn. https://www.linkedin.com/company/curesyngap1/ - 1,430 YouTube. https://www.youtube.com/@CureSYNGAP1 - 11,286 Twitter https://twitter.com/cureSYNGAP1 - 46k Insta https://www.instagram.com/curesyngap1/ Episode 182 of #Syngap10 #CureSYNGAP1 #Advocate #PatientAdvocacy #UnmetNeed #SYNGAP1 #SynGAP #SynGAProMMiS
Audio roundup of selected biopharma industry content from Scrip over the business week ended September 5, 2025. In this episode: the US MASH market after Wegovy's approval; AstraZeneca and Mineralys in close hypertension race; United Therapeutics' Phase III win in IPF; Corsera aims to predict and prevent cardiovascular disease; and Ionis's RNA-targeted win in severe hypertriglyceridemia. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RKP4E4CFGFGGXBRVXTI73V27U4/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. During a Senate hearing, Robert F. Kennedy Jr. faced criticism for spreading anti-vaccine views and breaking promises regarding vaccines. The FDA released rejection letters for companies like Lykos Therapeutics, Stealth Biotherapeutics, and Regeneron. Ousted CDC director Susan Monarez accused Kennedy of firing her for not supporting Covid-19 recommendations from an advisory panel with "antivaccine rhetoric." Hengrui Pharmaceuticals signed lucrative deals with Merck and GSK, while the FDA promised to release future Complete Response Letters promptly. In other news, Sanofi's anti-OX40 blocker failed in a Phase III study, Gilead partnered with the US State Department for low-income countries, and AC Immune announced workforce cuts. Kennedy was accused of lying during the hearing, and the FDA released a new rare disease approval framework.
Sal talks The High Republic Adventures Phase III comic mini-series!This is my FAVORITE comic series!Daniel José Older and Harvey Tolibao make a perfect comic team!Love lost! Found! and a Wedding Spectacular!!Farzala and Qort lead at the battle of Eriadu!Maz and her pirates! Crash and her crew!Tarkin family business!!Gavi and Driggit at The Battle of Eriadu!The Warden! The Nihil! And even a little Niv Drendow!Memorial to the fallen!Bookended by memories and music Check out the Rogue Rebels The High Republic playlist!!Check out the Rogue Rebels Star Wars comics playlist!!Follow us EVERYWHERE!@TheRogueRebels on Bluesky!IG: @TheRogueRebels The Rogue Rebels on FBTikTok @TheRogueRebels
ImmuPharma PLC (AIM:IMM) CEO Tim McCarthy and CSO Dr Sébastien Goudreau talked with Proactive's Stephen Gunnion about the company's latest milestone — the filing of a new patent application for its lead drug candidate P140, described as the world's first “immunormaliser” for treating autoimmune diseases. This patent filing marks a major development in the company's mission to bring P140 to market, with McCarthy describing it as a “truly groundbreaking” innovation and part of ImmuPharma's 2025 plan to deliver commercial outcomes. The filing is expected to support licensing discussions, offering potential partners a new 20-year exclusivity window. Goudreau provided scientific context, explaining the work his team has carried out since 2021 to understand the shortfalls of the previous Phase III trial. “We have succeeded… to identify the responder to P140,” he said, referring to patients with a newly defined immune disorder, Type M. The team also developed a diagnostic test to detect “super responders,” which is now part of the new patent. The patent includes three key discoveries: confirmation of P140's mechanism in human biology, the identification of the Type M immune disorder, and the development of the companion diagnostic. Goudreau emphasised that P140 acts as an “immune normaliser,” rather than a suppressor — a unique approach with potential to improve treatment outcomes and reduce side effects. McCarthy added that this patent strengthens ImmuPharma's commercial position, providing leverage in current licensing talks and opening access to a therapeutic market worth over $100 billion and a diagnostics market valued at around $10 billion. For more exclusive interviews and insights, visit Proactive's YouTube channel. Don't forget to like this video, subscribe, and turn on notifications so you never miss an update. #ImmuPharma #P140 #AutoimmuneDiseases #BiotechNews #PharmaInnovation #ClinicalTrials #DrugDevelopment #Immunotherapy #HealthcareTech #BiotechInvesting #PatentNews #Diagnostics #LifeSciences #InvestorUpdates #ProactiveInvestors
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Regeneron's experimental drug for myasthenia gravis, cemdisiran, has shown promising results in a Phase III trial and the company is aiming to file for FDA approval by 2026. Pharmaceutical spending in China has reached record levels, with more than $48 billion spent in the first half of the year. Former FDA Commissioner Scott Gottlieb has raised concerns about the US losing its edge in biopharma innovation to China. Additionally, a drug program for a rare neurodegenerative disorder has been discontinued by Amylyx, while pharma companies are increasingly focusing on scientific research and partnerships. Lilly's obesity pill is heading to the FDA for approval, AbbVie is investing in psychedelics, and HHS has announced more changes in the industry. The pharmaceutical landscape is rapidly evolving with new developments and challenges arising.Pharma CEOs are facing increasing pressure amid political turmoil and public distrust over drug pricing. The industry spent over $48 billion in China in the first half of the year, with expectations of increased deal volume in the future. Legal experts are working to determine ownership rights of AI creations in biotech. Obesity treatments are being compared for effectiveness, while biotech companies are making strides in AI-driven manufacturing. Job opportunities in gene therapy and biostatistics are available.
Eli Lilly posted data Tuesday from a second Phase III trial of its oral weight loss therapy orforglipron, providing the company with all it needs to head to the FDA with a new drug application. For more in-depth discussion on the oral weight-loss space, check out a special episode of The Weekly. And stay tuned to BioSpace for more unique coverage of this market as we learn which investigational assets will make it across the regulatory finish line and which will join the weight-loss wasteland. On the business side of biopharma, AbbVie turned back to neuropsychiatric therapies this week, acquiring partner Gilgamesh Pharmaceuticals' lead depression candidate for $1.2 billion. The deal is a display of resilience for AbbVie in the neuropsychiatric space as well, after the stunning failure last November of schizophrenia asset emraclidine—picked up in its nearly $9 billion acquisition of Cerevel Therapeutics. And is the cooler late summer weather thawing the IPO market? Neuropsych-focused LB Pharma revealed in an SEC filing on Friday that it plans to take the plunge, ending a six-month stalemate in biotech IPOs. Finally, the Department of Health and Human Services (HHS) has been busy this past week. On Monday, the CDC named Retsef Levi—a known vaccine critic—to head the agency's COVID-19 immunization working group, just as reports surfaced that the Trump administration could be “within months” of banning the COVID-19 vaccine in the U.S. Meanwhile, the FDA issued new draft guidance for cancer drug developers that prioritizes the use of survival data, and the agency began publishing drug-related adverse event reports daily. HHS itself has also been the subject of recent headlines, announcing that it will no longer recognize employee unions, and last week, hundreds of HHS staffers penned an open letter calling on Secretary Kennedy to tone down what they called “dangerous and deceitful statements” that have fostered distrust against federal health workers, exposing them to physical harm. This followed the Aug. 8 shooting at CDC headquarters in Atlanta. Finally, multinational pharmaceutical companies spent more than $48 billion on partnerships with China in the first half of 2025 alone, according to a new report from IQVIA—more than in all of 2024.
Oral therapies are projected to account for 25% of the anti-obesity medication market by 2030—but first returns have largely disappointed. This month, shares of both Eli Lilly and Viking Therapeutics took a hit as investors reacted negatively to highly anticipated Phase III and Phase II results for their respective candidates.While the 9.1% placebo-adjusted weight loss generated by Lilly's orforglipron over 72 weeks was an efficacy miss by most analyst accounts, tolerability tripped up oral VK2735's otherwise best-case efficacy scenario—10.9% weight loss after just 13 weeks. These murky results have left observers wondering, just how game-changing these pills will be and which ones will be most effective?In such a hot space, Lilly's and Viking's results—which follow Novo Nordisk's new drug application for an oral form of Wegovy in May—are only the tip of the iceberg. Stay tuned to BioSpace for further in-depth coverage of the space as we learn which investigational assets will make it across the regulatory finish line and which will join the weight-loss wasteland.
I remember hearing these amapiano tracks back in 2020 - 2021 tough times but the music kept us going and still is. I'll call this one "night pulse" definitely amapiano that never sleeps.
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Novo Nordisk's drug Wegovy has received approval for label expansion, potentially boosting its market performance. Tonix has also secured approval for a new fibromyalgia medication. Additionally, Novo has teamed up with GoodRx to provide lower prices for its drugs. Merck KGaA has made a significant investment of $2 billion in RNA-targeting technology through a collaboration with Skyhawk Therapeutics. On the sterilization front, Fedegari now offers tailored solutions for the pharmaceutical sector. In other updates, Pfizer's sickle cell therapy did not succeed in Phase III trials, while gene therapy company Kriya has raised an impressive $313 million. Kennedy has shown support for mRNA vaccines in cancer treatment. Bausch Health has closed a facility, Precigen has received FDA approval for an immunotherapy drug, and Eli Lilly has partnered with Superluminal in the obesity pipeline. Stay tuned for more industry news and developments.
Audio roundup of selected biopharma industry content from Scrip over the business week ended August 15, 2025. In this episode: a look at the likely top drugs in 2030; Lilly CEO advocates US/Europe pricing rebalance; Insmed sees $5bn-plus market for Brinsupri; royalty deals go mainstream; Phase III win sets stage for Epkinly label expansion. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-365OXHOS2RFXHPEDQIURY6LFDI/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
What if we could finally crack the code on treating brain cancer by opening the door that's blocked 98% of therapies? In this episode, Dr. Michael Canney, Chief Scientific Officer of Carthera, reveals how SonoCloud—a revolutionary ultrasound implant—temporarily opens the blood-brain barrier to deliver chemotherapy directly to tumors like glioblastoma. With over 100 patients enrolled in a Phase III trial across 40 global sites, this isn't just a bold idea—it's happening now. Michael also shares real-world lessons in scaling trials, FDA navigation, and aligning science with commercial success. If you're passionate about disruptive innovation in neuro-oncology, you'll want to hear how Carthera is changing the game.
Vinay Prasad is back at the FDA as chief of the FDA's Center for Biologics Evaluation and Research. Prasad's return—which hit the news wires Saturday morning—came just 10 days after his unexpected exit on July 29, following blowback over the saga involving Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy Elevidys, and a campaign by conversative personalities to oust the outspoken physician.Elsewhere in the government, Gray Delany, former head of HHS' and President Donald Trump's Make America Healthy Again agenda, has been fired—days after Health and Human Services Secretary Robert F. Kennedy Jr. axed 22 mRNA vaccine contracts under the Biomedical Advanced Research and Development Authority. Delany's ouster came after he allegedly butted heads with other agency officials over how announcements were made, according to reporting from Endpoints News. The mRNA contract cuts, meanwhile, have sparked criticism from the scientific community and concern that the growing anti-mRNA sentiment could also have a negative effect on research for cancer therapeutics.In somewhat related news, the Annals of Internal Medicine is refusing to retract a large-scale study it ran in July that pointed to the lack of an association between childhood aluminum exposure through vaccination and chronic conditions, despite Kennedy's criticism. In an op-ed published earlier this month, the Health Secretary took issue with the study's design.In obesity news, biopharma darling Eli Lilly suffered a rare chink in its normally impenetrable GLP-1 armor. The first Phase III trial for oral weight loss therapy orforglipron read out last week, and the results were underwhelming, at least to Wall Street. Truist Securities wrote that the data support approval but “leaves room for competition.” This is good news for a whole host of companies, including Roche, Viking, Terns and Rhythm Pharmaceuticals, who all have weight loss pills at various stages of development.And in gene therapy, the hits just keep coming. The FDA has limited the use of bluebird bio's gene therapy Skysona to patients with cerebral adrenoleukodystrophy for whom no other therapies or stem cell donors are available, due to a heightened risk of blood cancers. This follows safety issues in gene therapy trials experienced by Allogene, and, of course, Sarepta Therapeutics. This week in ClinicaSpace, Dan Samorodnitsky explored the future of AAV technology. And in BioPharm Executive, Annalee Armstrong sat down with Chris Anzalone, CEO of Arrowhead Pharmaceuticals—Sarepta's key strategic partner—to learn how his company has been weathering the storm.
Phase III data from Lilly's orforglipron in obesity fell short of investor expectations, but they appear to be enough to obtain approval and wide use. On the latest BioCentury This Week podcast, BioCentury's analysts discuss why the first-in-class oral small molecule GLP-1R agonist's clean safety profile and clear manufacturing advantage over oral peptides give the product a leg-up in the market.They then discuss Vinay Prasad's return to FDA after a brief hiatus, the revamped strategy of 32-year-old San Diego biotech Acadia Pharmaceuticals, and an attempt in the Senate to revive the Biosecure Act targeting China biotechs.Finally, the analysts preview this year's Back to School package, which reimagines FDA. At a time of unprecedented change in government agencies, BioCentury's 33rd Back to School asks what FDA could look like if it were reorganized from the ground up to create the regulator patients deserve and industry needs. View full story: https://www.biocentury.com/article/656727#orforglipron #CBER #VinayPrasad #AcadiaPharmaceuticals00:00 - Introduction00:49 - Prasad07:09 - Back to School12:29 - Lilly Obesity21:58 - Acadia's Comeback28:50 - Biosecure ActTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text
In this episode of the Exploring Mining Podcast, we dive deep into the exciting journey of Terra Balcanica Resources Corp., a polymetallic and energy explorer making waves in the mining industry. Alex Mišković, P.Geo. and CEO, shares the company's evolution from a private venture started in 2020 to a publicly listed entity on the CSE (TERA) in 2022, raising over $9.5 million to fuel its ambitious exploration programs including advanced geophysics, soil sampling, and diamond drilling . Alex highlights the strategic importance of antimony, a critical metal for Europe's defense and energy transition sectors, and Silver, a cornerstone of the project, continues to deliver intercepts that rival global leaders, With a strategic foothold in Bosnia and Herzegovina's mining-friendly jurisdiction, Terra is capitalizing Phase III drilling campaign, silver-antimony intercepts, and more!About the CompanyTerra Balcanica is a polymetallic and energy metals exploration company targeting large-scale mineral systems in the Balkans of southeastern Europe and northern Saskatchewan, Canada. The Company has 90% interest in the Viogor-Zanik Project in eastern Bosnia and Herzegovina. The Canadian assets comprise a 100% optioned portfolio of uranium-prospective licences at the outskirts of the world-renowned Athabasca basin: Charlot-Neely Lake, Fontaine Lake, Snowbird, and South Pendleton. The Company emphasizes responsible engagement with local communities and stakeholders. It is committed to proactively implementing Good International Industry Practice (GIIP) and sustainable health, safety, and environmental management. https://terrabresources.com/en/ Follow on X @terrabalcanicaDisclaimer/Disclosure: This podcast featuring are paid for content at Investorideas.com, (payment disclosure). Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions. More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/ Global investors must adhere to regulations of each country. Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.aspFollow us on X @investorideas @Exploringmining Follow us on Facebook https://www.facebook.com/Investorideas #CommodityInvesting #MiningStocks #SilverMining #PreciousMetals #SilverPrice #ExplorationStocks #InvestInSilver #MiningInvestments #Antimony #ResourceStocks
Cette semaine, la saga hebdomadaire House of Émile / Powers of Aurélien se téléporte au mois de juin. On en profite pour parler de l'univers Ultimate mais aussi pour un coup de cœur directement tiré des années 90. Après cela, on se dirige vers une Galaxie lointaine, très lointaine pour nos recommandations hors-Marvel de 2025 !Coups de cœur de juin :Ultimate Universe N°04, 05 & 06 (100% Marvel) de collectifLe Gant de l'Infini (Marvel Omnibus) de Jim Starlin, George Pérez, collectifLes lectures hors Marvel :Star Wars Légendes : La Génèse des Jedi T03 (Star Wars Epic Collection) de collectifStar Wars La Haute République - Phase III
Center for Drug Evaluation and Research Head George Tidmarsh will oversee the Center for Biologics Evaluation and Research on an acting basis after Vinay Prasad's abrupt departure hours after the recording of last week's episode of The Weekly. While the situation is being billed as temporary, rumors are swirling that structural changes may be afoot at the FDA with Commissioner Marty Makary looking for better drug, biologic alignment.Meanwhile, the agency has come under criticism for another recent decision—one apparently driven by CDER's Oncology Center of Excellence director Richard Pazdur: the rejection of Replimmune's advanced melanoma drug, RP1. According to reporting by multiple outlets, Pazdur opposed the consensus opinion of CBER staff to approve the drug. The research team behind Replimmune's Phase III study penned an open letter to the FDA on Friday responding to the issues outlined in the agency's complete response letter. Meanwhile, the FDA's Sarepta saga continues, highlighting “unprecedented” FDA leaks and a veritable communications disaster.On the business side of biopharma, Q2 earnings continue to unfurl, with Pfizer, Vertex, BioNTech, Merck and Moderna all reporting this past week. Merck's $3 billion savings push has claimed 6,000 jobs, contributing to a brutal July that saw the entire biopharma industry axe 7,900 employees, a 487% year-over-year increase, based on BioSpace tallies. Meanwhile, Pfizer CEO Albert Bourla confirmed he has been in direct contact with President Donald Trump to negotiate a path forward on Most Favored Nation drug pricing after the president sent letters to 17 Big Pharma companies—and posted on his Truth Social platform—asking them to comply with the policy within 60 days or face potential unspecified consequences.In other policy news, the Centers for Medicare and Medicaid Services is reportedly considering coverage of GLP-1 drugs for weight management and obesity—reviving a Biden era proposal the Trump admin scrapped earlier this year.Finally, in BioPharm Executive this week, we have a special report on the situation in China as international drugmakers swoop into the region to find new drug candidates, while other companies build their therapeutic farm systems from incubators and venture arms. And check out BioSpace's brand new Manufacturing Brief, where we bring you the latest news and analysis in the area of biopharma manufacturing, starting with a feature on how to make cell and gene therapies commercially viable.
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Roche has dropped an early-stage obesity asset, CT-173, citing lack of competitiveness. Novartis has entered into a drug discovery deal with Matchpoint Therapeutics, acquiring global rights on all molecules for several inflammatory diseases. AstraZeneca claims a Phase III win with its nanobody treatment for myasthenia gravis. Second-quarter earnings season is approaching, and biotechs to watch include Sarepta and others facing challenges in the biopharma industry. Genentech downsizes as priorities shift, and GSK's comeback for Blenrep is on pause as the FDA delays its decision. The FDA's lack of transparency has tarnished Sarepta's reputation after patient deaths triggered an FDA battle. Opportunities in the industry include roles like Quality Specialist at CSL and Clinical Research Physician at Eli Lilly and Company.
Eine Monsterjägerin geht um. Doch eigentlich ist sie ganz nett und die wirklichen Monster sind die Menschen. Was klingt wie der Trailer zu The Witcher IV, ist eigentlich die Geschichte von Ty Yorrick aus den beiden Comicbänden Das Monster vom Tempelberg und Söldnerin mit Lichtschwert. Doch sie bringt noch eine ganz eigene Vorgeschichte mit, die mit ihren Abenteuern und ihrem ungewollten Schüler Drewen verschmilzt. Während sie also Monster jagt, sich mit Kindern rumschlägt und wichtige Leute rettet, wird Ty Yorrick wirklich sympathisch und das alles in einem Gewand aus wunderbaren Zeichnungen von Rachael Stott. Zeit für Theo, Julian und Tobias mal genauer in diese beiden Comicbände zu schauen und zu klären, warum Ty eine Figur ist, die durch Qualität statt Quantität überzeugt. Wieso lockert sie die typische Jedi-Riege etwas auf? Wie gelingt es Cavan Scott exemplarisch eigene Handlung und die Handlung von Phase III miteinander zu verschmelzen und wieso lauert hinter Drewen keine Ezra-Gefahr? Um all diese Fragen und ein zelebrieren der Zeichnungen – die beide Comic-Bände zu einem nahtlosen Werk verschmelzen –, dreht sich diese Ausgabe Ausgelesen! Zeitmarken spoilerfreier Teil 00:00:00 - Begrüßung 00:01:47 - Erwartungen 00:03:50 - Rolle in der Hohen Republik 00:05:49 - Toss a Coin to your Witcher 00:08:58 - Eine Augenweide! Spoilerteil 00:16:16 - Die Handlung 00:19:53 - So geht verknüpftes Storytelling 00:28:50 - Ty-Fighter 00:35:04 - Drewen und die Ezra-Gefahr 00:43:26 - Teradine: Jedi Lost 00:51:21 - Starke Nebenfiguren 01:03:46 - Fazit Blick in die Datenbank Zur Werksübersicht von Das Monster vom Tempelberg (The Monster at Temple Peak), geschrieben von Cavan Scott Die vier Hefte erschienen von August bis November 2021 monatlich bei IDW Am 27. Juli 2022 erschien der deutschsprachige Sonderband bei Panini; für die Noris Force Con 2022 gab es eine Version mit Variantcover. Am 20. Oktober 2022 erschien ein englischsprachiger Sammelband bei Panini UK Am 31. Oktober 2023 erschien ein englischsprachiger Sammelband beim neuen Lizenznehmer Dark Horse Zur Werksübersicht von Söldnerin mit Lichtschwert (Saber for Hire), geschrieben von Cavan Scott Drei Hefte erschienen von April bis Juni 2024 monatlich bei Dark Horse. Heft vier erschien erst im Oktober 2024 – vier Monate nach dem dritten Heft. Am 29. Januar 2025 erschien ein englischsprachiger Sammelband bei Dark Horse Am 30. Juni 2025 erschien der deutschsprachige Sonderband bei Panini Die Rezensionen Matthias hat im Juli 2023 Das Monster vom Tempelberg für euch rezensiert. Darin lobt er, dass die Lesenden mehr über die Vorgeschichte der Figuren erfahren. Die Handlung darüber hinaus besitze jedoch wenig Relevanz für das Gesamtprojekt. Sein Fazit daher: "Es ist eine solide, runde Geschichte, in der wir einiges darüber lernen, wie Ty Yorrick so tickt." Tobias hat im Juni 2025 Söldnerin mit Lichtschwert rezensiert und war überrascht davon, wie gut es Cavan Scott gelingt, eigene Handlung und galaxisweite Handlung miteinander zu verbinden. Das alles, ohne eine der beiden Seiten zu vernachlässigen. Er schlussfolgert daher: "Cavan Scott schafft es, seine eigenen Figuren glänzen zu lassen (Drewen, Lene, Ty), dabei Figuren aus dem größeren Kontext aufzugreifen (ganz viel Liebe an Kip und Jom!) und am Ende einen plausiblen Übergang zur Ty Yorrick aus Die Prüfungen der Jedi zu schreiben. Dabei alles in einem einheitlichen Stil, der sich sowohl visuell als auch narrativ durch beide Bände zieht und damit eine Ty-Dilogie schafft, die im Comicsektor ganz weit nach oben gehört – sowohl in als auch außerhalb der Hohen Republik." Den JediCast abonnieren Wir sind auf allen gängigen Podcast-Plattformen vertreten! Abonniert uns also gerne auf Spotify, Apple Podcasts, Google Podcasts (etc.), oder fügt bequem unsere Feeds in euren präferierten Podcast-Player ein. Alle Links dazu findet ihr oben unter dem Player verlinkt sowie auch jederzeit unter dem Audioplayer in der rechten Sidebar. Wir freuen uns auch immer über Bewertungen auf den jeweiligen Podcast-Seiten. Falls ihr umfangreichere Anmerkungen habt, schreibt auch gerne eine Mail an podcast@jedi-bibliothek.de! Eure Meinung Habt ihr Ty Yorrick nach diesen beiden Bänden mit anderen Augen gesehen? Habt ihr diese vor oder nach Trials of the Jedi gelesen? Wie hat sich euer Bild auf Ty dadurch verändert? Wie gefielen euch die ganzen Nebenfiguren und Hauptfiguren der Reihe neben Ty? Was ist euer Lieblingspanel von Rachael Stott und habt ihr schon einen Posterrahmen bestellt? All das gerne in die Kommentare!
Julie's brand new Big Gorgeous Goals: Official Workbook can be ordered now! Grab your copy.Dr. Joan Fallon shares her journey from clinical practice to founding Curemark, a biotech company developing novel therapies for Autism based on her discovery of enzyme deficiencies in children with the condition. Her innovative approach challenges traditional pharmaceutical development by addressing the physiological root causes of Autism rather than just treating symptoms.Dr. Joan Fallon, Founder and CEO of Curemark, is a visionary scientist dedicated to improving the health and well-being of children globally. Under her leadership, Curemark has developed novel therapies for diseases with limited treatment options, including a Phase III clinical program for Autism and research on Parkinson's Disease, schizophrenia, and addiction. The company's first drug, CM-AT, targeting autism, has earned Fast Track status from the FDA. Dr. Fallon holds over 400 patents, has authored numerous scholarly articles, and is a sought-after lecturer. Recognized as one of Goldman Sachs' Top 100 Most Intriguing Entrepreneurs of 2020 and a recipient of the EY Entrepreneur Of The Year Award in 2017, she also published her first book, Goodbye, Status Quo: Reimagining the Landscape of Innovation, in 2022. A respected business leader, doctor, and academic, Joan is passionate about sharing her insights on entrepreneurship and innovation.You can connect with Dr. Joan Fallon on LinkedIn. You can also learn more about Curemark on their website.Love the show or want to request a topic? Send us a text! (All submissions are anonymous, so if you'd like a reply, please include your email address!)You can connect with Julie on LinkedIn or Instagram. Find Julie's writing at her blog or by ordering her book Big Gorgeous Goals and the brand new official companion workbook! What did you think of this conversation? We'd love if you'd rate or review our show!
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.George Tidmarsh, a biopharma veteran and adjunct professor at Stanford's medical school, has been appointed as the new head of the FDA's Center for Drug Evaluation and Research (CDER). His extensive industry experience will be valuable in his new government position. Data secrecy among cell and gene therapy developers is hindering progress in the field, causing fragmentation, stalling innovation, and delaying access to treatments. Meanwhile, Sarepta is facing challenges with its elevidys shipments and has lost platform designation for its technology. At the same time, Roche's phase III trial in COPD has failed, impacting the market path for astegolimab. Layoffs are happening at companies like GSK, Sail, and BioNTech. Experts are exploring new ways to overcome barriers in cell therapy production.Data secrecy among cell and gene therapy developers continues to hinder progress and access to treatments. Acadia has introduced a new team and pipeline with ambitious goals. Patients are fighting for access to Brainstorm's ALS drug after promising real-world data. Moderna's withdrawal of its flu vaccine has left combination flu/COVID-19 vaccines in limbo. In other news, Sarepta is facing challenges with its DMD gene therapy, Ultragenyx's gene therapy for Sanfilippo syndrome is rejected by the FDA, GSK's Blenrep loses an adcomm vote, and BMS' anemia drug Reblozyl fails a Phase III trial. The FDA is experiencing layoffs and employee turnover amid an overhaul. Vinay Prasad overruled reviewers on Moderna's COVID-19 shot for kids. Upcoming events include a webinar on AI for real-world research and job opportunities in the biopharma industry. Readers are encouraged to provide feedback and suggest topics for future coverage.
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The U.S. Department of Health and Human Services (HHS) has begun formally laying off thousands of employees following a Supreme Court ruling allowing the Trump administration to reorganize the agency. FDA Commissioner Marty Makary has proposed lowering industry user fees to make it easier for smaller companies and academics to participate in the regulatory process. Developments in HIV and prep treatments are being presented at the IAS 2025 conference, while a new dual glp-1/gip molecule from Hengrui and Kailera Therapeutics has shown promising weight loss results in Phase III trials. A new 96-channel pipettor from Rainin is also being promoted to streamline library preparation for next-generation sequencing. Updates on Acadia's pipeline, FDA rejections for Ultragenyx, advancements in narcolepsy treatments by Takeda, and the potential use of psychedelics in depression treatment are also discussed in this episode. Stay tuned for more updates on the latest news and developments in the pharmaceutical and healthcare industries.
While most of the U.S. was celebrating the 4th of July holiday, President Donald Trump was busy signing the One Big, Beautiful Bill into law. This wide-ranging tax law has a few implications for the biopharma industry, including expanded IRA exemptions for orphan drugs. Looking ahead to the second half of 2025, BioSpace reviews some of the upcoming catalysts highlighted by Jefferies' “Halftime Show” report,including a highly anticipated Phase III readout for Eli Lilly's oral obesity candidate orforglipron and an eye on rare disease decisions under the “new” FDA. Speaking of FDA decisions, this week kicked off with a surprise approval—that of KalVista's Pharmaceuticals' Ekterly for hereditary angioedema. The road to approval for Ekterly was not a smooth one, after the FDA delayed its target action date and Endpoints News reported that FDA Commissioner Marty Makary tried to have the application rejected. More regulatory controversy is afoot as Health Secretary Robert F. Kennedy Jr. is facing yet another lawsuit. A group of medical organizations have sued Kennedy and other health leaders in an attempt to reverse Kennedy's recent decision to remove COVID-19 shots from the routine immunization guidelines for healthy children and healthy pregnant women. In other vaccine news, Kennedy endorsed the expanded use of RSV vaccines for people 50 through 59 years old who are at risk of severe disease—following the recommendation of the CDC vaccine advisory committee he turfed last month. This seeming reversal of sentiment largely mirrors the Secretary's massive HHS overhaul, which has already seen several of these layoffs reversed. In ClinicaSpace this week, we take a deep dive into the numbers. Also in ClinicaSpace, we feature four therapies hanging tough in a troubled TIGIT space that has seen several companies burn billions of dollars on failed assets. And BrainStorm Cell Therapeutics is back in the news after signaling support for a Citizens' Petition submitted to the FDA requesting the approval of its cell therapy NurOwn, whose Biologics License Application was withdrawn in 2023. Finally, in BioPharm Executive, we take a deep dive into the burgeoning longevity space and unpack the short-lived marriage between Novo Nordisk and Hims & Hers Health.
Oz joins Jose and Trev to try and untangle some of the confusion around phase III
The U.S. Supreme Court closed out its session before breaking for summer on Friday, ruling that decisions around coverage of HIV PrEP drugs should be left up to the U.S. Preventive Services Task Force. The ruling thwarted a lawsuit brought by a group of insurance providers who challenged the Affordable Care Act's requirement that they cover preventive medicines, such as HIV drugs, recommended by the task force. The high court also determined that members of this task force can be removed at will by HHS Secretary Robert F. Kennedy Jr.Speaking of HHS committees from which members have been removed at will by Kennedy, the CDC's revamped Advisory Committee on Immunization Practices convened last week for its first meeting since the roster overhaul, where a vote on Merck's recently approved RSV-targeting monoclonal antibody Enflonsia and a discussion around the inclusion of preservative thimerosal in influenza vaccines was on the docket, but an expected vote on Moderna's mRNA-based RSV shot mRESVIA was not.Also dominating the headlines on Friday was the FDA's decision to remove the Risk Evaluation and Mitigation Strategies (REMS) program from the six approved CAR T therapies it was applied to. Analysts and patient groups lauded the move, which is expected to potentially double access to these life-saving therapies, saying it reflects “thoughtful consideration of real-world evidence” and “regulatory trust.”Willliam Blair noted that it could be a “positive signal” to companies developing CAR T therapies for autoimmune diseases, which now includes AbbVie. In an all-cash buyout on Monday, the Illinois-based pharma dropped $1.2 billion for Capstan Therapeutics and its in vivo edited CAR T therapy for B cell–mediated autoimmune diseases. M&A has been on an uptick of late, and private equity companies—such as those that snapped up bluebird bio—are also getting in on the game.Finally, after Lykos Therapeutics' high profile failure last summer, the psychedelics space is heating up once again. While a Phase III readout of Compass Pathways' psilocybin drug last week in treatment-resistant depression received a muted reaction from investors, the response to a Phase II readout for Beckley Psytech and atai Life Sciences' intranasal psychedelic was more positive.
How does a MARS Officer and Ship's Team Diver become a Special Operations helicopter pilot? What does it take to get through the intense rigours of Phase III helicopter training — and then make the leap to 427 Special Operations Aviation Squadron?In this episode, we sit down with Captain Erin Edwards, a SOF Aircraft Commander, recipient of the prestigious Elsie MacGill Award, and currently serving as a CAPCOM at NASA in Houston.We explore her remarkable journey through the Canadian Armed Forces — from her early days at sea to commanding aircraft with Special Operations Forces. Erin shares personal stories of perseverance, leadership, and what it truly means to earn your place among the best.
The FDA's Diversity Action Plan guidance underwent several changes in recent months—with the draft guidance taken down, restored, and then pulled again—creating uncertainty for sponsors planning Phase III and pivotal trials across all therapeutic areas. With the final guidance expected by June 26, CRO regulatory leaders reflected on how companies can manage this evolving environment. They explored: The impact of the FDA's changing Diversity Action Plan guidance on sponsors' trial planning How companies adapted strategies to maintain inclusivity goals amid shifting regulatory priorities Broader implications for trial design, pipeline strategies, and sponsor approaches in the global drug development landscape This episode is part 2 of 4 in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Stay tuned for the next episode, where we'll continue exploring the key forces shaping the future of clinical trials. Listen to part 1 here: https://insights.citeline.com/scrip/partnered-content/podcast-series-navigating-regulatory-changes-market-dynamics-cro-perspectives-on-the-future-of-clinical-trials-26Q4Q35N6BHTZGLHIKHK6V2NXY/
Sal talks The High Republic comic mini-series' Echoes of Fear and Dispatches From the Occlusion Zone!The High Republic is almost over!!Old Pathfinder EX droids sending messages!Things are building on Eriadu!Driggit hacking droids and sending messages!Emerick Caphtor and Niv Drendow... best friends?Ty Yorick heads to Dalna!Tay and Lourna fighting side by side!Storytime with Reath Silas!Sith Lord Darth Ravi and the puzzle moon!More stories of Barnabus Vim!Legends of the Rod of Ages and the last Echo Stone! Check out the Rogue Rebels The HighRepublic playlist!!Follow us EVERYWHERE!@TheRogueRebels on Bluesky!IG: @TheRogueRebels The Rogue Rebels on FBTikTok @TheRogueRebels
Topics covered in this episode: * Free-threaded Python no longer “experimental” as of Python 3.14* typed-ffmpeg pyleak * Optimizing Test Execution: Running live_server Tests Last with pytest* Extras Joke Watch on YouTube About the show Sponsored by PropelAuth: pythonbytes.fm/propelauth66 Connect with the hosts Michael: @mkennedy@fosstodon.org / @mkennedy.codes (bsky) Brian: @brianokken@fosstodon.org / @brianokken.bsky.social Show: @pythonbytes@fosstodon.org / @pythonbytes.fm (bsky) Join us on YouTube at pythonbytes.fm/live to be part of the audience. Usually Monday at 10am PT. Older video versions available there too. Finally, if you want an artisanal, hand-crafted digest of every week of the show notes in email form? Add your name and email to our friends of the show list, we'll never share it. Brian #1: Free-threaded Python no longer “experimental” as of Python 3.14 “PEP 779 ("Criteria for supported status for free-threaded Python") has been accepted, which means free-threaded Python is now a supported build!” - Hugo van Kemenade PEP 779 – Criteria for supported status for free-threaded Python As noted in the discussion of PEP 779, “The Steering Council (SC) approves PEP 779, with the effect of removing the “experimental” tag from the free-threaded build of Python 3.14.” We are in Phase II then. “We are confident that the project is on the right path, and we appreciate the continued dedication from everyone working to make free-threading ready for broader adoption across the Python community.” “Keep in mind that any decision to transition to Phase III, with free-threading as the default or sole build of Python is still undecided, and dependent on many factors both within CPython itself and the community. We leave that decision for the future.” How long will all this take? According to Thomas Wouters, a few years, at least: “In other words: it'll be a few years at least. It can't happen before 3.16 (because we won't have Stable ABI support until 15) and may well take longer.” Michael #2: typed-ffmpeg typed-ffmpeg offers a modern, Pythonic interface to FFmpeg, providing extensive support for complex filters with detailed typing and documentation. Inspired by ffmpeg-python, this package enhances functionality by addressing common limitations, such as lack of IDE integration and comprehensive typing, while also introducing new features like JSON serialization of filter graphs and automatic FFmpeg validation. Features : Zero Dependencies: Built purely with the Python standard library, ensuring maximum compatibility and security. User-Friendly: Simplifies the construction of filter graphs with an intuitive Pythonic interface. Comprehensive FFmpeg Filter Support: Out-of-the-box support for most FFmpeg filters, with IDE auto-completion. Integrated Documentation: In-line docstrings provide immediate reference for filter usage, reducing the need to consult external documentation. Robust Typing: Offers static and dynamic type checking, enhancing code reliability and development experience. Filter Graph Serialization: Enables saving and reloading of filter graphs in JSON format for ease of use and repeatability. Graph Visualization: Leverages graphviz for visual representation, aiding in understanding and debugging. Validation and Auto-correction: Assists in identifying and fixing errors within filter graphs. Input and Output Options Support: Provide a more comprehensive interface for input and output options, including support for additional codecs and formats. Partial Evaluation: Enhance the flexibility of filter graphs by enabling partial evaluation, allowing for modular construction and reuse. Media File Analysis: Built-in support for analyzing media files using FFmpeg's ffprobe utility, providing detailed metadata extraction with both dictionary and dataclass interfaces. Michael #3: pyleak Detect leaked asyncio tasks, threads, and event loop blocking with stack trace in Python. Inspired by goleak. Use as context managers or function dectorators When using no_task_leaks, you get detailed stack trace information showing exactly where leaked tasks are executing and where they were created. Even has great examples and a pytest plugin. Brian #4: Optimizing Test Execution: Running live_server Tests Last with pytest Tim Kamanin “When working with Django applications, it's common to have a mix of fast unit tests and slower end-to-end (E2E) tests that use pytest's live_server fixture and browser automation tools like Playwright or Selenium. ” Tim is running E2E tests last for Faster feedback from quick tests To not tie up resources early in the test suite. He did this with custom “e2e” marker Implementing a pytest_collection_modifyitems hook function to look for tests using the live_server fixture, and for them automatically add the e2e marker to those tests move those tests to the end The reason for the marker is to be able to Just run e2e tests with -m e2e Avoid running them sometimes with -m "not e2e" Cool small writeup. The technique works for any system that has some tests that are slower or resource bound based on a particular fixture or set of fixtures. Extras Brian: Is Free-Threading Our Only Option? - Interesting discussion started by Eric Snow and recommended by John Hagen Free-threaded Python on GitHub Actions - How to add FT tests to your projects, by Hugo van Kemenade Michael: New course! LLM Building Blocks in Python Talk Python Deep Dives Complete: 600K Words of Talk Python Insights .folders on Linux Write up on XDG for Python devs. They keep pulling me back - ChatGPT Pro with o3-pro Python Bytes is the #1 Python news podcast and #17 of all tech news podcasts. Python 3.13.4, 3.12.11, 3.11.13, 3.10.18 and 3.9.23 are now available Python 3.13.5 is now available! Joke: Naming is hard
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The Summit's bispecific drug missed the survival endpoint in a global Phase III trial, but analysts remain optimistic about its potential to appeal to both Eastern and Western patient populations. Sanofi and Regeneron saw their shares tumble after a follow-up drug failed a Phase III COPD test. RFK Jr.'s report on health was found to have fake citations, casting doubt on its credibility. Astellas made a $1.5 billion bet on a Chinese collaboration for a cancer drug. In other news, Merck CEO emphasized the importance of diversity, while other companies faced setbacks and layoffs. AGC Biologics will be at BIO International to discuss their capabilities in drug production.
The Pittsburgh Steelers started Phase III of their Organized Team Activities (OTAs) Tuesday, and while some might overlook these workouts because their in shorts, there is still a lot of value in these workouts. These workouts might not be an indicator of teams which will win more games in 2025, but they certainly aren't meaningless. That's the topic of the Wednesday "Let's Ride" podcast with Jeff Hartman, as well as the Mailbag Segment. This podcast is a part of the Steel Curtain Network, a part of the Fans First Sports Network. Learn more about your ad choices. Visit megaphone.fm/adchoices
Paul Kuharsky of Paul Kuharsky dot com joins the show to talk all things Titans and NFL as they open up Phase III of OTAs. What storylines are we paying attention to? How will the backup QB situation play out? Is there still a place for Treylon Burks on the team? We take your phones for PK.
The Jaguars are about to be at the halfway point of OTA's / Phase III of the Offseason Program. What have we learned? What questions do we still have?1010XL Jaguars Beat Reporter Hays Carlyon joins Mia O'Brien as he does each Wednesday to discuss + answer your questions LIVE!0:00 Open0:10 Intro ... it's Hot in Jax4:15 Travis Etienne & State of Running Back Room7:40 Bhayshul Tuten, specifically12:50 Weight Loss of Key Defensive Veterans18:40 "Getting Home with Four" & LB Play23:10 Curious Case of Devin Lloyd26:45 Trevor Lawrence: Good or Bad?35:04 Dyami Brown's Impact37:57 Which players will benefit most from coaching?42:20 Epic Hays Carlyon rant!Mia O'Brien is joined live by a rotation of guests Monday's, Wednesday's and Friday's at 9:04 AM. Episodes are also available on-demand at the 1010XL Podcast Network wherever you get your podcasts.
Cam Ward took the field against a defense for the first time as a Titan during Phase III of OTAs, and he was...fine. Is that a good thing?
The Titans are hitting the field today for Phase III of OTAs. There is one national pundit who is giving the Titans some love. What are we looking for at OTAs, and we get Joe's thoughts on the team trying to build leadership this offseason. We get into some of the latest news and notes from the SEC spring meetings and what that could mean for the CFP. We finish up the hour with the Rex Rant.
Faraday Copper says they have made a new blind discovery of the Winchester Breccia during their Phase III drill program at the Copper Creek Project in Arizona. New exploration results from Outcrop Silver & Gold and Soma Gold. Kenorland Minerals has wrapped up its winter drill program with Auranova at the South Uchi Project. This episode of Mining Stock Daily is brought to you by... Vizsla Silver is focused on becoming one of the world's largest single-asset silver producers through the exploration and development of the 100% owned Panuco-Copala silver-gold district in Sinaloa, Mexico. The company consolidated this historic district in 2019 and has now completed over 325,000 meters of drilling. The company has the world's largest, undeveloped high-grade silver resource. Learn more at https://vizslasilvercorp.com/Calibre Mining is a Canadian-listed, Americas focused, growing mid-tier gold producer with a strong pipeline of development and exploration opportunities across Newfoundland & Labrador in Canada, Nevada and Washington in the USA, and Nicaragua. With a strong balance sheet, a proven management team, strong operating cash flow, accretive development projects and district-scale exploration opportunities Calibre will unlock significant value.https://www.calibremining.com/Integra is a growing precious metals producer in the Great Basin of the Western United States. Integra is focused on demonstrating profitability and operational excellence at its principal operating asset, the Florida Canyon Mine, located in Nevada. In addition, Integra is committed to advancing its flagship development-stage heap leach projects: the past producing DeLamar Project located in southwestern Idaho, and the Nevada North Project located in western Nevada. Learn more about the business and their high industry standards over at integraresources.com
Papilledema describes optic disc swelling (usually bilateral) arising from raised intracranial pressure. Due to its serious nature, there is a fear of underdiagnosis; hence, one major stumbling points is correct identification, which typically requires a thorough ocular examination including visual field testing. In this episode, Kait Nevel, MD speaks with Susan P. Mollan, MBChB, PhD, FRCOphth, author of the article “Papilledema” in the Continuum® April 2025 Neuro-ophthalmology issue. Dr. Nevel is a Continuum® Audio interviewer and a neurologist and neuro-oncologist at Indiana University School of Medicine in Indianapolis, Indiana. Dr. Mollan is a professor and neuro-ophthalmology consultant at University Hospitals Birmingham in Birmingham, United Kingdom. Additional Resources Read the article: Papilledema Subscribe to Continuum®: shop.lww.com/Continuum Earn CME (available only to AAN members): continpub.com/AudioCME Continuum® Aloud (verbatim audio-book style recordings of articles available only to Continuum® subscribers): continpub.com/Aloud More about the American Academy of Neurology: aan.com Social Media facebook.com/continuumcme @ContinuumAAN Host: @IUneurodocmom Guest: @DrMollan Full episode transcript available here Dr Jones: This is Dr Lyell Jones, Editor-in-Chief of Continuum. Thank you for listening to Continuum Audio. Be sure to visit the links in the episode notes for information about earning CME, subscribing to the journal, and exclusive access to interviews not featured on the podcast. Dr Nevel: Hello, this is Dr Kait Nevel. Today I'm interviewing Dr Susan Mollan about her article Papilledema Diagnosis and Management, which appears in the April 2025 Continuum issue on neuro-ophthalmology. Susie, welcome to the podcast, and please introduce yourself to our audience. Dr Mollan: Thank you so much, Kait. It's a pleasure to be here today. I'm Susie Mollan, I'm a consultant neuro-ophthalmologist, and I work at University Hospitals Birmingham- and that's in England. Dr Nevel: Wonderful. So glad to be talking to you today about your article. To start us off, can you please share with us what you think is the most important takeaway from your article for the practicing neurologist? Dr Mollan: I think really the most important thing is about examining the fundus and actually trying to visualize the optic nerves. Because as neurologists, you're really acutely trained in examining the cranial nerves, and often people shy away from looking at the eyes. And it can give people such confidence when they're able to really work out straightaway whether there's going to be a problem or there's not going to be a problem with papilledema. And I guess maybe a little bit later on we can talk about the article and tips and tricks for looking at the fundus. But I think that would be my most important thing to take away. Dr Nevel: I'm so glad that you started with that because, you know, that's something that I find with trainees in general, that they often find one of the more daunting or challenging aspects of learning, really, how to do an excellent neurological exam is examining the fundus and feeling confident in diagnosing papilledema. What kind of advice do you give to trainees learning this skill? Dr Mollan: So, it really is practice and always carrying your ophthalmoscope with you. There's lots of different devices that people can choose to buy. But really, if you have a direct ophthalmoscope, get it out in the ward, get it out in clinic. Look at those patients that you'd know have alternative diagnosis, but it gives you that practice. I also invite everybody to come to the eye clinic because we have dilated patients there all the time. We have diabetic retinopathy clinics, and it makes it really easy to start to acquire those skills because I think it's very tricky, because you're getting a highly magnified view of the optic nerve and you've got to sort out in your head what you're actually looking at. I think it's practice. and then use every opportunity to really look at the fundus, and then ask your ophthalmology colleagues whether you can go to clinic. Dr Nevel: Wonderful advice. What do you think is most challenging about the evaluation of papilledema and why? Dr Mollan: I think there are many different aspects that are challenging, and these patients come from lots of different areas. They can come from the family doctor, they can come from an optician or another specialist. A lot of them can have headache. And, as you know, headache is almost ubiquitous in the population. So, trying to pull out the sort of salient symptoms that can go across so many different conditions. There's nothing that's pathognomonic for papilledema other than looking at the optic nerves. So, I think it's difficult because the presentation can be difficult. The actual history can be challenging. There are those rare patients that don't have headache, don't have pulsatile tinnitus, but can still have papilledema. So, I think it- the most challenging thing is actually confirming papilledema. And if you're not able to confirm it, getting that person to somebody who's able to help and confirm or refute papilledema is the most important thing. Dr Nevel: Yeah, right. Because you talk in your article the importance of distinguishing between papilledema and some other diagnoses that can look like papilledema but aren't papilledema. Can you talk about that a little bit? Dr Mollan: Absolutely. I think in the article it's quite nice because we were able to spend a bit of time on a big table going through all the pseudopapilledema diagnoses. So that includes people with shortsightedness, longsightedness, people with optic nerve head drusen. And we've been very fortunate in ophthalmology that we now have 3D imaging of the optic nerve. So, it makes it quite clear to us, when it's pseudopapilledema, it's almost unfair when you're using the direct ophthalmoscope that you don't get a cross sectional image through that optic nerve. So, I'd really sort of recommend people to delve into the article and look at that table because it nicely picks out how you could pick up pseudopapilledema versus papilledema. Dr Nevel: Perfect. In your article, you also talk about what's important to think about in terms of causes of papilledema and what to evaluate for. Can you tell us, you know, when you see someone who you diagnose with papilledema, what do you kind of run through in terms of diagnostic tests and things that you want to make sure you're evaluating for or not missing? Dr Mollan: Yeah. So, I think the first thing is, is once it's confirmed, is making sure it's isolated or whether there's any additional cranial nerve palsies. So that might be particularly important in terms of double vision and a sixth nerve palsy, but also not forgetting things like corneal sensation in the rest of the cranial nerves. I then make sure that we have a blood pressure. And that sounds a bit ridiculous in this day and age because everybody should have a blood pressure coming to clinic or into the emergency room. But sometimes it's overlooked in the panic of thinking, gosh, I need to investigate this person. And if you find that somebody does have malignant hypertension, often what we do is we kind of stop the investigational pathway and go down the route of getting the medics involved to help with lowering the blood pressure to a safe level. I would then always think about my next thing in terms of taking some bloods. I like to rule out anemia because anemia can coexist in a lot of different conditions of raised endocranial pressure. And so, taking some simple blood such as a complete blood count, checking the kidney function, I think is important in that investigational pathway. But you're not really going to stop there. You're going to move on to neuroimaging. It doesn't really matter what you do, whether you do a CT or an MRI, it's just getting that imaging pretty much on the same day as you see the patient. And the key point to that imaging is to do venography. And you want to rule out a venous sinus thrombosis cause that's the one thing that is really going to cause the patient a lot of morbidity. Once your neuroimaging is secure and you're happy, there's no structural lesion or a thrombosis, it's then reviewing that imaging to make sure it's safe to proceed with lumbar puncture. And so, we would recommend the lumbar puncture in the left lateral decubitus position and allowing the patient to be as calm and relaxed as possible to be able to get that accurate opening pressure. Once we get that, we can send the CSF for contents, looking for- making sure they don't have any signs of meningitis or raised protein. And then, really, we're at that point of saying, you know, we should have a secure diagnosis, whether it would be a structural lesion, venous sinus thrombosis, or idiopathic intracranial hypertension. Dr Nevel: Wonderful. Thank you for that really nice overview and, kind of, diagnostic pathway and stepwise thought process in the evaluations that we do. There are several different treatments for papilledema that you go through in your article, ranging from surgical to medication options. When we're taking care of an individual patient, what factors do you use to help guide you in this decision-making process of what treatment is best for the patient and how urgent treatment is? Dr Mollan: I think that's a really important question because there's two things to consider here. One is, what is the underlying diagnosis? Which, hopefully, through the investigational save, you'll have been able to achieve a secure diagnosis. But going along that investigational pathway, which determines the urgency of treatment, is, what's happening with the vision? If we have somebody where we're noting that the vision is affected- and normally it's actually through a formal visual field. And that's really challenging for lots of people to get in the emergency situation because syndromes of raised endocranial pressure often don't cause problems with the visual acuity or the color vision until it's very late. And also, you won't necessarily get a relative afferent papillary defect because often it's bilateral. So I really worry if any of those signs are there in somebody that may have papilledema. And so, a lot rests on that visual field. Now, we're quite good at doing confrontational visual fields, but I would say that most neurologists should be carrying pins to be able to look at the visual fields rather than just pointing fingers and quadrants if you're not able to get a formal visual field early. It's from that I would then determine if the vision is affected, I need to step up what I'm going to do. So, I think the sort of next thing to think about is that sort of vision. So, if we have somebody who, you know, you define as have severe sight loss at the point that you're going through this investigational pathway, you need to get an ophthalmologist or a neuro-ophthalmologist on board to help discuss either the surgery teams as to whether you need to be heading towards an intervention. And there are a number of different types of intervention. And the reason why we discuss it in the article---and we'll also be discussing it in a future issue of Continuum---is there's not high-class evidence to suggest one surgery over another surgery. We may touch on this later. So, we've got our patients with severe visual loss who we need to do something immediately. We may have people where the papilledema is moderate, but the vision isn't particularly affected. They may just have an enlarged blind spot. For those patients, I think we definitely need to be thinking about medical therapy and talking to them about what the underlying cause is. And the commonest medicine to use for raised endocranial pressure in this setting is acetazolamide, a carbonic anhydrous inhibitor. And I think that should be started at the point that you believe somebody has moderate papilledema, with a lot of discussion around the side effects of the medicine that we go into the article and also the fact that a lot of our patients find acetazolamide in an escalating dose challenging. There are some patients with very mild papilledema and no visual change where I might say, hey, I don't think we need to start treatment immediately, but you need to see somebody who understands your disease to talk to you about what's going on. And generally, I would try and get somebody out of the emergency investigational pathway and into a formal clinic as soon as possible. Dr Nevel: Thank you so much for that. One thing that I was wondering that we see clinically is you get a consult for a patient, maybe, who had an isolated episode of vertigo, back to their normal self, completely resolved… but incidentally, somebody ordered an MRI. And that MRI, in the report, it says partially empty sella, slight flattening of the posterior globe, concerns for increased intracranial pressure. What should we be doing with these patients who, you know, normal neurological exam, maybe we can't detect any definite papilledema on our endoscopic exam. What do you think the appropriate pathway is for those patients? Dr Mollan: I think it's really important. The more neuroimaging that we're doing, we're sort of seeing more people with signs that are we don't believe are normal. So, you've mentioned a few, the sort of partially empty sella, empty sella, tortuosity of the optic nerves, flattening of the globes, changes in transverse sinus. And we have quite a nice, again, table in the article that talks about these signs. But they have really low sensitivity for a diagnosis of raised endocranial pressure and isolation. And so, I think it's about understanding the context of which the neuroimaging has been taken, taking a history and going back and visiting that to make sure that they don't have escalating headache. And also, as you said, rechecking the eye nerves to make sure there's no papilledema. I think if you have a good examination with the direct ophthalmoscope and you determine that there's no papilledema, I would be confident to say there's no papilledema. So, I don't think they need to necessarily cry doubt. The ophthalmology offices, we certainly are having quite a few additional referrals, particularly for this, which we kind of called IIH-RAD, where patients are coming to us for this exclusion. And I think, in the intervening time, patients can get very anxious about having a sort of MRI artifact picked up that may necessarily mean a different diagnosis. So, I guess it's a little bit about reassurance, making sure we've taken the appropriate history and performed the examination. And then knowing that actually it's really a number of different signs that you need to be able to confidently diagnose raised ICP, and also the understanding that sometimes when people have these signs, if the ICP reduces, those signs remain. You know, we're learning an awful lot more about MRI imaging and what's normal, what's within normal limits. So, I think reassurance and sensible medical approach. Dr Nevel: Absolutely. In the section in your article on idiopathic intracranial hypertension, you spend a little bit of time talking about how important it is that we sensitively approach the topic of potential weight loss for those patients who are overweight. How do you approach that discussion in your clinic? Because I think it's an important part of the holistic patient care with that condition. Dr Mollan: I think this is one of the things that we've really listened to the patients about over the last number of years where we recognize that in an emergency situation, sometimes we can be quite quick to sort of say, hey, you have idiopathic endocranial hypertension and weight loss is, you know, the best treatment for the condition. And I think in those circumstances, it can be quite distressing to the patient because they feel that there's a lot of stigma attached around weight management. So, we worked with the patient group here at IIH UK to really come up with a way of a signposting to our patients that we have to be honest that there is a link, you know, a strong evidence that weight gain and body shape change can cause someone to fall into a diagnosis of IIH. And we know that weight loss is really effective with this condition. So, I think where I've learned from the patients is trying to use language that's less stigmatizing. I definitely signpost that I'm going to talk about something sensitive. So, I say I'm going to talk about something sensitive and I'm going to say, do you know that this condition is related to body shape change? And I know that if I listen to this podcast in a couple of years, I'm sure my words will have changed. And I think that's part of the process, is learning how to speak to people in an ever-changing language. And they think that sort of signpost that you're going to talk about something sensitive and you're going to talk about body shape change. And then follow up with, are you OK with me talking about this now? Is it something you want to talk about? And the vast majority of people say, yes, let's talk about it. There'll be a few people that don't want to talk about it. And I usually come in quite quickly, say, is it OK if I mention it at the next consultation? Because we have a duty of care to sort of inform our patients, but at the same time we need to take them on that journey to get them back to health, and they need to be really enlisted in that process. Dr Nevel: Yeah, I really appreciate that. These can be really difficult conversations and uncomfortable conversations to have that are really important. And you're right, we have a duty as medical providers to have these conversations or inform our patients, but the way that we approach it can really impact the way patients perceive not only their diagnosis, but the relationship that we have with our patients. And we always want that to be a positive relationship moving forward so that we can best serve our patients. Dr Mollan: I think the other thing as well is making sure that you've got good signposts to the professionals. And that's what I say, because people then say to me, well, you know, kind of what diet should I be on? What should I be doing? And I say, well, actually, I don't have professional experience with that. I'm, I'm very fortunate in my hospital, I'm able to send patients to the endocrine weight management service. I'm also able to send patients to the dietetic service. So, it's finding, really, what suits the patient. Also what's within licensing in your healthcare system to be able to provide. But not being too prescriptive, because when you spend time with weight management professionals, they'll tell you lots of different things about diets that people have championed and actually, in randomized controlled trials, they haven't been effective. I think it's that signpost really. Dr Nevel: Yeah, absolutely. So, could you talk a little bit about what's going on in research in papilledema or in this area, and what do you think is up-and-coming? Dr Mollan: I think there's so much going on. Mainly there's two parts of it. One is image analysis, and we've had some really fantastic work out of the Singapore group Bonsai looking at a machine learning decision support tool. When people take fundal pictures from a normal fundus camera, they're able to say with good certainty, is this papilledema, is this not papilledema? But more importantly, if you talk to the investigators, something that we can't tell when we look in is they're able to, with quite a high level of certainty, say, well, this is base occupying lesion, this is a venous sinus thrombosis, and this is IIH. And you know, I've looked at thousands and thousands of people's eyes and that I can't tell why that is. So, I think the area of research that is most exciting, that will help us all, is this idea about decision support tools. Where, in your emergency pathway, you're putting a fundal camera in that helps you be able to run the image, the retina, and also to try and work out possibly what's going on. I think that's where the future will go. I think we've got many sort of regulatory steps and validation and appropriate location of a learning to go on in that area. So, that's one side of the imaging. I think the other side that I'm really excited about, particularly with some of the work that we've been doing in Birmingham, is about treatment. The surgical treatments, as I talked about earlier… really, there's no high-class evidence. There's a number of different groups that have been trying to do randomized trials, looking at stenting versus shunting. They're so difficult to recruit to in terms of trials. And so, looking at other treatments that can reduce intracranial pressure. We published a small phase two study looking at exenatide, which is a glucagon-like peptide receptor agonist, and it showed in a small group of patients living with IIH that it could reduce the intracranial pressure two and a half hours, twenty-four hours, and also out to three months. And the reason why this is exciting is we would have a really good acute therapy---if it's proven in Phase III trials---for other diseases, so, traumatic brain injury where you have problems controlling ICP. And to be able to do that medically would be a huge breakthrough, I think, for patient care. Dr Nevel: Yeah, really exciting. Looking forward to seeing what comes in the future then. Wonderful. Well, thank you so much for chatting with me today about your article. I really enjoyed learning more from you during our conversation today and from your article, which I encourage all of our listeners to please read. Lots of good information in that article. So again, today I've been interviewing Dr Susie Mollan about her article Papilledema Diagnosis and Management, which appears in the most recent issue of Continuum on neuro-ophthalmology.Please be sure to check out Continuum episodes from this and other issues. And thank you to our listeners for joining us today. Thank you, Susie. Dr Mollan: Thank you so much. Dr Monteith: This is Dr Teshamae Monteith, Associate Editor of Continuum Audio. If you've enjoyed this episode, you'll love the journal, which is full of in-depth and clinically relevant information important for neurology practitioners. Use the link in the episode notes to learn more and subscribe. AAN members, you can get CME for listening to this interview by completing the evaluation at continpub.com/audioCME. Thank you for listening to Continuum Audio.
The latest episode of the DDW Highlights podcast is now available to listen to below. DDW's Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. With Eli Lilly so far winning the race to bring an oral GLP-1 drug to market, having announced positive topline results from a Phase III trial, this week our news highlights focus on clinical studies. You can listen below, or find The Drug Discovery World Podcast on Spotify, Google Play and Apple Podcasts.
Kenyan President William Ruto wrapped up a four-day visit to China on Friday and returned home with a massive new railway deal and more than a billion dollars of investment pledges. Ruto's successful closing of the Phase III extension of the Standard Gauge Railway to the Ugandan border comes after nearly a decade of Kenyan lobbying in China. Also, this week, Eric & Géraud are at the Salzburg Global Forum in Austria, where they joined a diverse group of civil society stakeholders from across Africa to participate in a lively week-long conference on centering an African vision for a new multilateral future. JOIN THE DISCUSSION: X: @ChinaGSProject | @christiangeraud Facebook: www.facebook.com/ChinaAfricaProject YouTube: www.youtube.com/@ChinaGlobalSouth Now on Bluesky! Follow CGSP at @chinagsproject.bsky.social FOLLOW CGSP IN FRENCH AND ARABIC: Français: www.projetafriquechine.com | @AfrikChine Arabic: عربي: www.alsin-alsharqalawsat.com | @SinSharqAwsat JOIN US ON PATREON! Become a CGSP Patreon member and get all sorts of cool stuff, including our Week in Review report, an invitation to join monthly Zoom calls with Eric & Cobus, and even an awesome new CGSP Podcast mug! www.patreon.com/chinaglobalsouth
Have you wondered why having more drug options matters for chronic rhinosinusitis with nasal polyps? In the inaugural episode of our new series, The Itch Review, co-hosts Kortney and Dr. Payel Gupta, along with special guest Dr. Michael Blaiss, unpack the journal article "Tezepelumab in Adults with Severe Chronic Rhinosinusitis with Nasal Polyps," published in the New England Journal of Medicine on March 1, 2025. This article is about the Phase III WAYPOINT trial of tezepelumab. Already approved for severe asthma, this once-monthly biologic is now showing promise in chronic rhinosinusitis with nasal polyps (CRSwNP). Over 52 weeks, 408 patients were randomized to receive 210 mg of tezepelumab every four weeks or placebo. Researchers tracked nasal-polyp scores, congestion, sense of smell, and rates of rescue surgery. In this episode, we provide a brief overview of what CRSwNP is, why inflammation drives polyp formation and how blocking TSLP fits into today's biologics options. We'll walk you through the WAYPOINT Phase III design, explain the primary and secondary endpoints, and translate the headline results into what they mean for real-world patients who've exhausted their treatment options. ➡️ Get the infographic here. What we cover in our episode about treating chronic rhinosinusitis with nasal polyps with tezepelumab CRSwNP basics & tezepelumab mechanism of action: How nasal polyps form and why targeting TSLP can reduce inflammation WAYPOINT design: 52-week, placebo-controlled Phase III study in 408 patients Primary endpoints: Mean change in nasal polyp score and nasal-congestion score Secondary endpoints: Smell recovery, need for rescue surgery or systemic steroids, and quality-of-life measures Why choice matters: Every CRSwNP patient responds differently, and having more treatment options means more chances to find the right fit Made in partnership with The Allergy & Asthma Network. Thanks to AstraZeneca for sponsoring today's episode. This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. In a recent interview with former Fox News journalist Megyn Kelly, FDA Commissioner Marty Makary discussed a potential new mechanism-driven pathway for expedited rare disease approvals, as well as the possibility of certain environmental factors contributing to autism. Despite Makary's announcement of a directive to limit industry participation in the FDA's advisory committees, industry involvement is actually required by a 1997 law, and banning industry representatives would not have a significant impact. Additionally, the FDA recently approved Sanofi/Regeneron's Dupixent for chronic hives after initially rejecting it, and Lilly has promised to manufacture a weight-loss pill in the US following a Phase III win. The newsletter also includes other news stories, opinions, and upcoming events in the biopharmaceutical industry.
Audio roundup of selected biopharma industry content from Scrip over the business week ended 14 March 2025. In this episode: Roche's big new obesity deal; J&J opts out of next-gen Darzalex; Arvinas and Pfizer's protein degrader misses Phase III endpoint; Kelun wins first TROP2 ADC approval in lung cancer; and big name brands poised to lose US exclusivity. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-QOIAKBVZ2FDQ7NL2SFMWK66HP4/ This episode was produced using AI text-to-voice and voice emulation software. Let me know your views: ian.haydock@citeline.com. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Watch The X22 Report On Video No videos found Click On Picture To See Larger Picture Trump has now ended the attack on gas stoves, everything that Biden has done is being reversed. Lee Zeldin found the money and is returning to the people. Politico admits the job numbers are fake. Trump has begun the parallel economy, tariffs are being implemented. The end of the Fed is coming. The [DS] players are panicking, the people are now seeing that there are rats everywhere. DOGE is setting up a transparent system so the people can see it all. This was not just another 4 year election this was a crossroads to see if can keep the country. Phase I and II happening right now. Once the people see the criminals and the treason that they have committed we will be moving to Phase III, a traitors justice. (function(w,d,s,i){w.ldAdInit=w.ldAdInit||[];w.ldAdInit.push({slot:13499335648425062,size:[0, 0],id:"ld-7164-1323"});if(!d.getElementById(i)){var j=d.createElement(s),p=d.getElementsByTagName(s)[0];j.async=true;j.src="//cdn2.customads.co/_js/ajs.js";j.id=i;p.parentNode.insertBefore(j,p);}})(window,document,"script","ld-ajs"); Economy Trump Admin Formally Ends Biden's War on Gas Stoves The Consumer Product Safety Commission is formally ending a review that it initiated during the Biden administration to assess the potential health risks posed by gas-powered stovetops. In a statement to the Washington Free Beacon, Consumer Product Safety Commission acting chairman Peter Feldman said he considers the matter "concluded" and emphasized that the federal government should not interfere with consumer choice. Feldman's comments effectively put an end to a years-long process that critics feared would lead to a broad ban on gas stoves. " "I became Acting Chairman of the United States Consumer Product Safety Commission in January 2025, shortly after President Trump's inauguration," he continued. "So long as I have a say in the matter, the CPSC is out of the gas-stoves-banning business. The agency has no plans to advance such a rule." Source: freebeacon.com EPA Chief Lee Zeldin Pledges to Recover $20 Billion Lost by Biden Administration for Climate Projects Lee Zeldin, EPA Chief for the Trump administration, has pledged to recover the $20 billion in taxpayer funds lost by the Biden administration to climate projects. Zeldin made the announcement in a video posted to social media on Wednesay when he charged the Biden administration of “throwing gold bars of the Titanic” in relation to the money lost on climate projects that he said was a “rush job with reduced oversight.” “The days of irresponsibly shoveling boatloads of cash to far-left activist groups in the name of environmental justice and climate equity are over,” Zeldin said. “The American public deserves a more transparent and accountable government than what transpired these past four years.” Source: breitbart.com https://twitter.com/epaleezeldin/status/1889840040622321778 Rep. Jan Schakowsky Suggests Women Might Not Pursue Jobs in Manufacturing Because “Man” is in the Name (Video) Rep. Jan Schakowsky (D-IL) pushed a bizarre explanation for why women might not pursue jobs in manufacturing. Schakowsky made her remarks on Wednesday during a Commerce, Manufacturing and Trade subcommittee hearing entitled “AI in Manufacturing: Securing American Leadership in Manufacturing and the Next Generation of Technologies.” Schakowsky suggested that perhaps the reason fewer women choose a career in manufacturing is that the term has the word “man” in it. https://twitter.com/libsoftiktok/status/1889833714974416938?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1889833714974416938%7Ctwgr%5E405aa74609e691f5897438e7cd78045186bc95f1%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Fwww.thegatewaypundit.com%2F2025%2F02%2Frep-jan-schakowsky-suggests-women-might-not-pursue%2F Source: thegatewaypunidt.com