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

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Your daily pharmaceutical news briefing — FDA decisions, clinical trial results, biotech M&A, and drug pipeline updates in under 15 minutes, every weekday. Hosted by Alex Mercer and Maya Patel. Plus a Weekend Edition every Sunday synthesizing the week's biggest moves in pharma and biotech. Covering drug approvals, pharma industry deals, biopharma investing, and healthcare market intelligence. Smart, fast, and built for professionals who need to stay ahead. Hosts voices are AI created

  1. 1d ago

    Jun 04, 2026 | SCOTUS Backs Hikma Skinny-Label Win on Vascepa; ADC Therapeutics Crashes 50% on Death

    SCOTUS unanimously backs Hikma's skinny-label Vascepa generic, reshaping patent defense for branded pharma. ADC Therapeutics drops 50%+ on LOTIS-5 death rate (13.2% vs 4.6%), biotech M&A crosses $106B in 2026, and Legend Biotech surges on in vivo CAR-T data. Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Hikma, Amarin, Vascepa, skinny label, Supreme Court, generics, ADC Therapeutics, Zynlonta, loncastuximab tesirine, DLBCL, LOTIS-5, Legend Biotech, CAR-T, in vivo, Novo Nordisk, manufacturing, Kyle Diamantas, Merck, WELIREG, KEYTRUDA, Alnylam, Inceptive, Parabilis, Fulcrum, Celcuity, Axsome, Sunosi, biotech M&A, COINS Act, Otsuka, Voyxact, IgA nephropathy, Pfizer, Novartis, GSK

    11 min

  2. 2d ago

    ASCO 2026 Special, Part 2 — ThClosing Days: Iza-bren Doubles Down in TNBC & Esophageal

    Part 2 of The Pharma Closeout's ASCO 2026 special covers the closing days, Monday June 1 and Tuesday June 2 — net-new readouts plus resolution of Part 1's June 1-2 watch-list. HEADLINE: izalontamab brengitecan (iza-bren), an EGFR-directed bispecific ADC, hits dual PFS+OS endpoints in pretreated TNBC (OS HR 0.60, PFS HR 0.29, ORR 52% vs 21%) and again in 2L esophageal squamous cancer (OS HR 0.64). BREAST: persevERA misses (giredestrant+palbociclib, HR 0.89, p=0.16); SERENA-6 final PFS2 (camizestrant, HR 0.63); I-SPY 2.2. GI: HERIZON-GEA-01 (zanidatamab+tislelizumab >2-yr OS, HR 0.72); EMERALD-3 (STRIDE+lenvatinib+TACE liver, PFS HR 0.70); ivonescimab 1L MSS CRC (ORR 71%); FIGHT-302; ATTRACTION-6 miss. GU/GYNE/OCULAR: OptimUM-02 (darovasertib+crizotinib, first Phase 3 win in HLA-A*02:01-neg uveal melanoma, PFS HR 0.42 — covered neutrally, Servier co-developer); RUBY (dostarlimab dMMR endometrial cure modeling, 4-yr OS HR 0.34); NRG-GY018 (HR 0.56); Bluestar (B7-H4 ADC); MIROVA miss. HEME: SENTRY (selinexor+rux MF, SVR35 49.8% vs 28%, OS HR 0.43, symptom co-primary missed); eganelisib; CLOVER-WaM. LUNG: ALCHEMIST adjuvant nivolumab negative (HR 0.97); MARIPOSA non-event (mature OS was a 2025 readout). MELANOMA: KEYNOTE-942 5-yr (intismeran autogene, 49% RFS reduction). H&N: FID-007. Themes: bispecifics/ADCs come of age, China-origin assets, and a wave of instructive negatives. Stock moves described qualitatively only.

    19 min

  3. 4d ago

    ASCO 2026 Special — Comprehensive Opening Weekend: Daraxonrasib Doubles Pancreatic OS

    ASCO 2026 comprehensive opening-weekend recap (28 readouts through Sunday, May 31). Headline: Revolution Medicines' RASolute 302 doubles overall survival in second-line pancreatic cancer (daraxonrasib, 13.2 vs 6.7months, HR 0.40). LUNG: CROWN 7-year (lorlatinib 55% vs 3% PFS), LIBRETTO-432 adjuvant selpercatinib (83% reduction), WU-KONG28 sunvozertinib, HARMONi-6ivonescimab (34% OS, soft reaction), OptiTROP-Lung05 sac-TMT (PFS HR 0.35), plus ROSETTA Lung-02, CHRYSALIS-2, Krascendo-170, elisrasib. BREAST: KEYNOTE-522 7-yr OS (85.1% vs 77.2%), lidERA. GI: RASolute 302, CIRCULATE ctDNA-guidedcolon, EPISODE-III aspirin miss. PROSTATE: PROTEUS, TALAPRO-3 (PARP into mHSPC rPFS HR 0.481). KIDNEY: RAMPART split. HEAD & NECK: TMC-I (~$225/moregimen, 43% death-risk reduction). GLIOMA: INDIGO vorasidenib (PFS 44.1mo). SARCOMA: SARC041 abemaciclib. HEME: MajesTEC-9 teclistamab, SUCCESSOR-2 mezigdomide, frontMIND tafasitamab, golcadomide, PRIMAVERA. MELANOMA: IGNYTE/RP1. SCREENING: NHS-Galleri miss. Plus the June 1-2 forward look. pharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, ASCO 2026,Revolution Medicines, daraxonrasib, RASolute 302, RAS, KRAS, pancreatic cancer,lorlatinib, CROWN, Pfizer, selpercatinib, LIBRETTO-432, RET fusion, lungcancer, NSCLC, sunvozertinib, WU-KONG28, Dizal, ivonescimab, HARMONi-6, Akeso,Summit Therapeutics, bispecific, sacituzumab tirumotecan, OptiTROP-Lung05,Kelun, Merck, ADC, pumitamig, BioNTech, amivantamab, lazertinib, CHRYSALIS-2,divarasib, Krascendo-170, elisrasib, pembrolizumab, KEYNOTE-522,triple-negative breast cancer, giredestrant, lidERA, Roche, CIRCULATE, ctDNA,colorectal cancer, EPISODE-III, aspirin, PROTEUS, apalutamide, Erleada,prostate cancer, Johnson & Johnson, talazoparib, enzalutamide, TALAPRO-3,PARP, RAMPART, durvalumab, kidney cancer, AstraZeneca, TMC-I, nivolumab, headand neck cancer, Tata Memorial, vorasidenib, INDIGO, glioma, Servier, SARC041,abemaciclib, liposarcoma, sarcoma, teclistamab, MajesTEC-9, mezigdomide,SUCCESSOR-2, multiple myeloma, BMS, tafasitamab, frontMIND, Incyte, DLBCL,golcadomide, PRIMAVERA, AZD3470, Hodgkin lymphoma, RP1, IGNYTE, Replimune,melanoma, NHS-Galleri, GRAIL, MCED, early detection, MARIPOSA, oncology, Lilly,J&J

    28 min

  4. 5d ago

    May 31, 2026 | ASCO 2026: Revolution Medicines Pancreatic Data Called 'Unprecedented'; Ivonescimab 34% OS

    RevMed's ASCO pancreatic cancer data earn 'unprecedented' from three major outlets — potential paradigm shift in a historically intractable tumor. Plus ivonescimab's 34% OS improvement with caveats,Pfizer-Innovent's $10.5B deal for 12 cancer programs, and GSK/Ionis's buried hepatitis B 'functional cure.' Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, RevolutionMedicines, ivonescimab, Akeso, Summit Therapeutics, Pfizer, Innovent Biologics,Eli Lilly, ASCO 2026, pancreatic cancer, KRAS, RAS, lung cancer, bepirovirsen,GSK, Ionis, hepatitis B, Braftovi, Lorbrena, Talzenna, Erleada, Zepbound,Foundayo, MannKind, Afrezza, Incyte, Monjuvi, DLBCL, BMS, Retevmo, Allogene,Lilly, Novo Nordisk, Merck, J&J

    12 min

  5. May 30

    May 29, 2026 | Pfizer's $10.5B Innovent Deal Extends China Licensing Wave; BMS Mezigdomide Phase 3

    Pfizer and Innovent strike a deal worth up to $10.5B for 12 cancer programs — the sixth mega-licensing deal out of China since last July. BMS wins Phase 3 for Pomalyst successor mezigdomide at ASCO 2026. Merck, Agios, MannKind, and PDUFA reauthorization round out a packed Friday. Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Pfizer, Innovent Biologics, Bristol Myers Squibb, mezigdomide, Pomalyst, CELMoD, ASCO 2026, Merck, China licensing, Biosecure Act, oncology, Agios, tebapivat, MDS, MannKind, Afrezza, AstraZeneca, Imfinzi, Tremfya, Venclyxto, Dizal Pharma, EGFR, Replimune, melanoma, Allogene, PDUFA reauthorization, drug pricing, most-favored-nation, Roche, J&J, AbbVie, BMS

    9 min

  6. May 29

    May 28, 2026 | GSK/Ionis Bepirovirsen Achieves 19% Functional Cure in Hepatitis B

    Bepirovirsen hits 19% functional cure rate in Phase 3 chronic HBV trials — a first for a disease affecting 300 million. Plus Spero's 245% surge on tebipenem, AstraZeneca's Imfinzi NMIBC approval, CVS restoring Lilly obesity drug coverage, BridgeBio LGMD data, Kardigan IPO plans, and ASCO 2026 abstracts drop. Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, bepirovirsen, GSK, Ionis, hepatitis B, functional cure, Spero Therapeutics, tebipenem, oral carbapenem, cUTI, CVS, Eli Lilly, Zepbound, Foundayo, obesity drugs, AstraZeneca, Imfinzi, durvalumab, bladder cancer, NMIBC, BridgeBio, BBP-418, LGMD, muscular dystrophy, Kardigan Therapeutics, MyoKardia, Secretome Therapeutics, Duchenne, ASCO 2026, Trump drug pricing, MFN, Akeso, Novo Nordisk, Merck, BioNTech, Moderna, Lilly, Sanofi, BMS

    11 min

  7. May 21

    May 20, 2026 | Pfizer's Next-Gen Pneumonia Vaccine Beats Prevnar 20; BMS Deploys Anthropic AI

    Pfizer's 25-valent pneumococcal shot shows 8.8x–15x higher antibody levels vs. Prevnar 20 in Phase 2, advancing to Phase 3. BMS deploys Claude across 30,000+ employees in landmark pharma-AI deal. Lilly acquires Engage Bio for $202M. Tavneos linked to 20 deaths in Japan. Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Pfizer, Prevnar 20, 25vPnC, pneumococcal vaccine, Bristol Myers Squibb, BMS, Anthropic, Claude, artificial intelligence, enterprise AI, Eli Lilly, Engage Biologics, Gilead Sciences, Yuhan, Amgen, Tavneos, avacopan, ImmunityBio, Anktiva, NMIBC, Parabilis, Relay Therapeutics, GHO Capital, CBC Group, PDUFA, Lilly, Novartis, Roche, Merck, Gilead, Regeneron

    11 min

  8. May 21

    May 19, 2026 | Takeda $885M Antitrust Verdict; Bimzelx Beats Skyrizi in PsA Head-to-Head

    Takeda hit with $885M pay-for-delay verdict over generic Amitiza delay. UCB's Bimzelx beats AbbVie's Skyrizi 49% vs 38% on ACR50 in PsA head-to-head. Trump bought up to $680K in Eli Lilly stock while admin promoted obesity drugs. Maryland caps Ozempic payments. Amgen Tavneos linked to 20 deaths in Japan. Relay zovegalisib Phase 2 data beats expectations.   Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Takeda, Amitiza, pay-for-delay, antitrust, UCB, Bimzelx, bimekizumab, AbbVie, Skyrizi, risankizumab, psoriatic arthritis, Trump, Eli Lilly, Zepbound, Mounjaro, obesity drugs, Maryland, Ozempic, Novo Nordisk, semaglutide, Amgen, Tavneos, avacopan, Relay Therapeutics, zovegalisib, BioMarin, ENPP1, Roche, Xofluza, Regeneron, Parabilis, Novartis, Porton, CDMO, Tarsier Pharma, drug pricing, Lilly, AstraZeneca

    11 min
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About

Your daily pharmaceutical news briefing — FDA decisions, clinical trial results, biotech M&A, and drug pipeline updates in under 15 minutes, every weekday. Hosted by Alex Mercer and Maya Patel. Plus a Weekend Edition every Sunday synthesizing the week's biggest moves in pharma and biotech. Covering drug approvals, pharma industry deals, biopharma investing, and healthcare market intelligence. Smart, fast, and built for professionals who need to stay ahead. Hosts voices are AI created

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