The Pharma Closeout | Daily Pharmaceutical & Biotech News in 15 minus

May 15, 2026 | FDA's CDER Chief Høeg Expected to Exit; Tecentriq Wins Bladder Cancer Approval

9 min · 17. maj 2026
episode May 15, 2026 | FDA's CDER Chief Høeg Expected to Exit; Tecentriq Wins Bladder Cancer Approval cover

Beskrivelse

Three top FDA positions now in temporary hands as CDER's Høeg follows Makary out the door. Roche's Tecentriq wins ctDNA-guided bladder cancer approval with 36% DFS and 41% OS risk reductions paired with Natera's Signatera diagnostic. Plus Enhertu's early breast cancer expansion, Rigel's $85M Veppanu deal, Biogen's tau gamble, and oral Wegovy's first prescription decline. Visit is at www.thephamacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, CDER, Tracy Beth Høeg, Marty Makary, Richard Pazdur, Roche, Tecentriq, atezolizumab, Natera, Signatera, ctDNA, bladder cancer, Enhertu, trastuzumab deruxtecan, Daiichi Sankyo, AstraZeneca, breast cancer, HER2, Novo Nordisk, Wegovy, oral semaglutide, GLP-1, Aardvark Therapeutics, ARD-101, Prader-Willi syndrome, Rigel Pharmaceuticals, Veppanu, vepdegestrant, Arvinas, Pfizer, United Therapeutics, UHeart, xenotransplantation, Biogen, BIIB080, tau, Alzheimer's, Takeda, Create Medicines, mifepristone, SCOTUS, Lilly, Merck

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85 episoder

episode Jun 22, 2026 | AbbVie's $10.9B Apogee Buy Targets Dupixent; 1st Solid Tumor CAR-T Approved in China cover

Jun 22, 2026 | AbbVie's $10.9B Apogee Buy Targets Dupixent; 1st Solid Tumor CAR-T Approved in China

AbbVie bets $10.9B on Apogee Therapeutics to challenge Dupixent — its biggest deal since Allergan. Plus: the first CAR-T approved for a solid tumor clears in China, Merck's $10.8B Prometheus IBD bet pays off with a Phase 3 win, and HHS clinical trial reforms target China.   Visit www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, AbbVie, Apogee Therapeutics, zumilokibart, Dupixent, Regeneron, Sanofi, CARsgen, CAR-T, Claudin 18.2, solid tumor, gastric cancer, Merck, Prometheus Biosciences, IBD, Keytruda, HHS, RFK Jr, clinical trial reform, Moderna, mFlusiva, Alnylam, Pfizer, Kardigan, MacroGenics, TZIELD, Bionyra, cAMPfield, WuXi Biologics, Novartis, pelacarsen, UniQure, AMT-130, Novo Nordisk, ransomware, BMS

23. juni 202610 min
episode Jun 19, 2026 | US Probes Germany Drug Pricing; Moderna Flu Vaccine Wins Unanimous FDA Panel cover

Jun 19, 2026 | US Probes Germany Drug Pricing; Moderna Flu Vaccine Wins Unanimous FDA Panel

US government opens formal probe into Germany's drug pricing reforms, escalating transatlantic pharma trade tensions. Kardigan IPO raises $400M and pops 31%. Moderna flu vaccine gets unanimous FDA advisory panel support ahead of Aug 5 PDUFA. Jazz and AbCellera strike $4.1B T cell engager collaboration. Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Germany drug pricing, US trade probe, Moderna flu vaccine, mFlusiva, Kardigan IPO, Jazz Pharmaceuticals, AbCellera, T cell engagers, Pfizer CFO Dave Denton, Eli Lilly, 4E Therapeutics, Edgewise Biosciences, HCM, Biogen, RayThera, Traws Pharma, tivoxavir marboxil, Merck Capvaxive, Treasury China biotech, cAMPfield, Vedana Therapeutics, Spot Bio, Innoviva, Lyndra, Sanofi, Aurobindo, Lannett, Pfizer, Lilly, Merck, Moderna

20. juni 202610 min
episode Jun 18, 2026 | Moderna mFlusiva Wins Unanimous VRBPAC Vote; NovoCure TRIDENT Fails in GBM cover

Jun 18, 2026 | Moderna mFlusiva Wins Unanimous VRBPAC Vote; NovoCure TRIDENT Fails in GBM

Moderna's mRNA flu vaccine gets unanimous FDA panel backing — PDUFA August 5. NovoCure's TRIDENT trial misses overall survival in glioblastoma; stock drops ~18%. Biogen acquires immunology startup RayThera for up to $1B; Kardigan IPO raises $400M. Visit us at www.thepharmacloseput.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Moderna, mFlusiva, MRNA, VRBPAC, mRNA flu vaccine, NovoCure, NVCR, TRIDENT, glioblastoma, TTFields, Biogen, BIIB, RayThera, immunology, Pfizer, PFE, CFO, Kardigan, IPO, cAMPfield, Legend Biotech, LEGN, Carvykti, Eli Lilly, 4E Therapeutics, Merck, Capvaxive, pneumococcal vaccine, Innoviva, Lyndra, Aurobindo, Lannett, FTC, Treasury, China biotech, Lilly, GSK, Sanofi

19. juni 202613 min
episode Jun 17, 2026 | UniQure AMT-130 Surges 70% on FDA Reversal; Jazz-AbCellera $4.1B TCE Deal cover

Jun 17, 2026 | UniQure AMT-130 Surges 70% on FDA Reversal; Jazz-AbCellera $4.1B TCE Deal

UniQure surges 70% as FDA reverses course on Huntington's gene therapy AMT-130 filing path. Jazz and AbCellera strike $4.1B T cell engager deal for GI cancers. Novo Nordisk faces $25M ransom demand after hackers claim drug formulations and AI models.   Visit www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, UniQure, QURE, AMT-130, Huntington's disease, gene therapy, FDA accelerated approval, Jazz Pharmaceuticals, AbCellera, T cell engagers, Novo Nordisk, cyberattack, data breach, Biogen, RayThera, immunology, Moderna, mFlusiva, VRBPAC, mRNA flu vaccine, GSK, Spero Therapeutics, complicated UTI, compounded GLP-1, Vedana Biosciences, Spot Bio, Triveni Bio, Colorado drug importation

18. juni 202614 min
episode Jun 16, 2026 | BridgeBio BBP-418 Sweeps LGMD Phase 3; FDA Scrutinizes Moderna Flu Vaccine cover

Jun 16, 2026 | BridgeBio BBP-418 Sweeps LGMD Phase 3; FDA Scrutinizes Moderna Flu Vaccine

BridgeBio's BBP-418 sweeps Phase 3 in limb-girdle muscular dystrophy — stock up 15%, no approved competition. FDA briefing docs challenge Moderna mFlusiva efficacy ahead of Thursday's VRBPAC vote. Plus Lilly acquires non-opioid pain startup 4E Therapeutics, Edgewise advances EDG-7500 toward Phase 3 in HCM, and Neumora abandons navacaprant after two Phase 3 failures. Visit www.thepharmacloseput.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, BridgeBio, BBP-418, LGMD, limb-girdle muscular dystrophy, Moderna, mFlusiva, VRBPAC, flu vaccine, Eli Lilly, 4E Therapeutics, non-opioid pain, MNK inhibitor, Edgewise, EDG-7500, HCM, hypertrophic cardiomyopathy, Adaptive Biotechnologies, MRD, Neumora, navacaprant, myelofibrosis, Jakafi, Be Biopharma, enGene, Parabilis, biotech IPO, Colorado drug import, Lilly, Novartis

17. juni 202610 min