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The Pharma Closeout | Daily Pharmaceutical and Biotech News in 15 Minutes

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 Week in Review every Sunday synthesizing the week"s biggest moves in pharma and biotech. Covering drug approvals, licensing and M&A deals, biopharma investing, and healthcare market intelligence. Smart, fast, and built for pharma and biotech professionals who need to stay ahead. Transcripts,

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00:10:57

Jun 04, 2026 | SCOTUS Backs Hikma Skinny-Label Win on...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/06/05

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.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Hikma, Amarin, Vascepa, skinny label, Supreme Court, generics, ADC Therapeutics,

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00:18:40

ASCO 2026 Special, Part 2 — ThClosing Days: Iza-bren...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/06/03

Part 2 of The Pharma Closeout's ASCO 2026 special covers the closing days, MondayJune 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 bispecificADC, 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

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00:27:30

ASCO 2026 Special — Comprehensive Opening Weekend:...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/06/01

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,

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00:11:58

May 31, 2026 | ASCO 2026: Revolution Medicines...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/06/01

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.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout,

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00:08:54

May 29, 2026 | Pfizer's $10.5B Innovent Deal Extends...

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2026/05/30

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.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Pfizer, Innovent Biologics, Bristol Myers Squibb, mezigdomide,

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00:10:34

May 28, 2026 | GSK/Ionis Bepirovirsen Achieves 19%...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/29

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.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, bepirovirsen, GSK, Ionis, hepatitis B,

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00:10:30

May 20, 2026 | Pfizer's Next-Gen Pneumonia Vaccine...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/21

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.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Pfizer, Prevnar 20, 25vPnC, pneumococcal vaccine, Bristol Myers Squibb, BMS,

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00:11:13

May 19, 2026 | Takeda $885M Antitrust Verdict;...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/21

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.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma

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00:10:40

May 18, 2026 | Regeneron LAG-3 Phase 3 Failure...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/19

Regeneron's fianlimab misses PFS endpoint in melanoma, erasing ~$8B in market cap. Supreme Court rejects IRA pricing challenges from six pharma companies. FDA approves AstraZeneca's first-in-class Baxfendy for hypertension. Merck's sac-TMT scores Phase 3 dual-endpoint win.Visit us at www.thepharmacloseput.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Regeneron, fianlimab, LAG-3, melanoma, REGN, Keytruda, pembrolizumab,

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00:09:56

May 15, 2026 | FDA's CDER Chief Høeg Expected to...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/17

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.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma

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00:10:37

May 14, 2026 | AstraZeneca Imfinzi Phase 3 Win in...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/15

AstraZeneca's VOLGA trial hits EFS and OS incisplatin-ineligible bladder cancer, putting Imfinzi squarely in Keytruda's lane. Plus: Regenxbio's Duchenne gene therapy heads for FDA filing amid safetysignals, a brain tumor linked to a viral vector raises AAV concerns, and biopharma rallies behind Richard Pazdur for FDA commissioner. Also: BMS-Hengrui$15.2B alliance, BeOne's Beqalzi challenges Venclexta, and Taiho's Inqovi expands into AML.visit us at

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00:10:27

May 13, 2026 | BeOne's Beqalzi Wins FDA Approval,...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/14

FDA approves Beqalzi (sonrotoclax) for mantle cell lymphoma — the first new BCL-2 inhibitor in a decade, directly challenging AbbVie's Venclexta franchise. Takeda slashes 4,500 jobs in a $1.26B restructuring; Lilly and Novo duel with new obesity maintenance data on the same day.Visit us a www.thepharmcloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, BeOne, Beqalzi, sonrotoclax, BCL-2 inhibitor, mantle cell lymphoma,

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00:10:37

May 12, 2026 | FDA Commissioner Makary Resigns;...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/13

FDA Commissioner Makary resigns; Kyle Diamantas steps in as acting chief amid regulatory upheaval. BMS and Hengrui ink $15.2B alliance across 13 programs in oncology, hematology, and immunology. Lilly's Foundayo maintains 82% of weight loss vs. Wegovy switch in ATTAIN-MAINTAIN Phase 3 data.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Marty Makary, Kyle Diamantas, Bristol Myers Squibb, BMS,

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00:11:07

May 11, 2026 | CSL Flags $5B Vifor Impairment as...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/12

CSL's $5B write-down from the Vifor Pharma acquisition sends shares to a nine-year low — the largest single-day drop on record. Inhibrx's INBRX-106 posts 44% ORR vs Keytruda's 21% in head and neck cancer. PlusRezdiffra clears $311M in Q1, Fractyl's GLP-1 gene therapy gets European clinical trial greenlight, and Daiichi Sankyo targets global top-5 oncology by 2035.visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare,

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00:13:57

May 10, 2026 | Vyvgart Wins Broadest gMG Label; Merck...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/11

FDA approves Vyvgart for all adult gMG serotypes two daysbefore PDUFA — argenx locks in broadest MG label with no FcRn rival in seronegative disease. Plus Merck's $6.7B Terns completion, Avalo's Phase 2 HS win, and Gilead's billion-dollar PrEP forecast.www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Vyvgart,efgartigimod, argenx, myasthenia gravis, seronegative gMG, ADAPT SERON, Merck,Terns

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00:10:24

May 08, 2026 | Trump Plans to Fire FDA Commissioner...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/09

FDA leadership in crisis — multiple outlets report Trump will fire Commissioner Makary after 14 turbulent months. Leqembi SC review extended three months to August 24. Bayer acquires Perfuse for $2.45B; Daiichi Sankyo takes $610M ADC manufacturing hit; Gilead targets $1B in Yeztugo sales.Visit us at www.thepharmcloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Marty Makary, Trump, Leqembi, lecanemab, Eisai, Biogen,

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00:10:27

May 07, 2026 | Angelini's $4.1B Catalyst Buyout;...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/08

Angelini Pharma pays $4.1B cash for Catalyst Pharmaceuticals — the fourth biotech buyout this month. Atara surges 40%+ on FDA path to resubmit tab-cel BLA. Roche acquires PathAI in $1B+ AI diagnostics deal. Duchenne takes two hits as Entrada data disappoint and Sarepta slides.Visit us at www. thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Angelini Pharma,Catalyst Pharmaceuticals, Firdapse, amifampridine,

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00:10:20

May 06, 2026 | Bayer Acquires Perfuse for $2.45B in...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/07

Bayer bets up to $2.45B on glaucoma drug maker PerfuseTherapeutics — its biggest pharma deal in years. Novo's oral Wegovy hits $355M in Q1, the strongest GLP-1 launch by volume in the US. Plus UCB's $2.2B Candid deal, GSK's $1B SiranBio siRNA licensing, Lilly's $4.5B manufacturing pledge, and Sanofi walks away from the FDA's CNPV program.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The

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00:10:25

May 05, 2026 | Cytokinetics Cracks Non-Obstructive...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/05

Myqorzo hits both endpoints in ACACIA-HCM, opening amultibillion-dollar HCM market Camzyos can't reach. Plus: Pfizer scraps its last CD47 program from the $2.3B Trillium acquisition, Madrigal licenses Arrowhead's PNPLA3 siRNA for up to $1B, and the Supreme Court keeps mifepristone in play.Visit us at www.thepharamcloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Cytokinetics,Myqorzo, aficamten, hypertrophic

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00:09:31

May 04, 2026 | SCOTUS Restores Mifepristone Mail...

The Pharma Closeout | Daily Pharmaceutical and... ·

2026/05/05

Supreme Court grants emergency stay restoring mifepristone access — and the ruling's implications hit every drugmaker's risk model. Plus: Arvinas/Pfizer's vepdegestrant becomes the first PROTAC approved by the FDA, UCB acquires Candid Therapeutics for $2.2B in autoimmune bispecifics, and Cytokinetics' pivotal HCM readout lands tomorrow.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout,

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