July 08, 2026| FDA Halts Drug Rejection Letters — What It Means for Competitive Intel

July 08, 2026| FDA Halts Drug Rejection Letters — What It Means for Competitive Intel

The FDA quietly paused publishing complete response letters after a citizen petition — reversing the Makary-era transparency push and closing a live window into rival drug failures. Plus: Sino Biopharmaceutical's dual respiratory deals with AstraZeneca ($200M upfront, TQC3721 in COPD) and GSK (Trelegy and Anoro Ellipta China rights), Vera Therapeutics' Trutakna approval in IgA nephropathy, Bristol Myers' Krazati confirmatory failure in colorectal cancer, Kailera's oral GLP-1 Phase 3 obesity data, Tampa General's 340B suit against Lilly over Mounjaro, and Biohaven's taldefgrobep push into muscle-sparing obesity. Visit us at www.thepharmacloseout.com Tags pharma, biotech, FDA, clinical trials, drug approvals, complete response letters, Sino Biopharmaceutical, AstraZeneca, GSK, Vera Therapeutics, IgA nephropathy, obesity

July 07, 2026| Vera's TRUTAKNA Wins FDA Nod: The eGFR Readout That Decides the IgAN Race

Vera Therapeutics wins FDA accelerated approval for TRUTAKNA (atacicept) in IgA nephropathy on a 42% placebo-adjusted proteinuria cut — setting up a head-to-head with Otsuka's VOYXACT. Plus Oberland Capital's up-to-$400M royalty deal for MeiraGTx eye gene therapies, Novartis cuts 322 New Jersey jobs, Bristol Myers' Krazati confirmatory failure in colorectal cancer, Roche's divarasib KRAS win, and Teva's early repigmentation data. Visit us at www.thepharmacloseout.com Tagspharma, biotech, FDA, clinical trials, drug approvals,TRUTAKNA, atacicept, Vera Therapeutics, IgA nephropathy, Otsuka VOYXACT, MeiraGTx, KRAS G12C

July 06, 2026| Vertex Buys Crinetics for $10B in Endocrinology Push

Vertex pays $10B cash for Crinetics Pharmaceuticals — its largest deal ever — betting on acromegaly drug Palsonify and Phase 3 CAH candidate atumelnant. Also: Novartis acquires ADC platform Myricx Bio for up to $1.5B; HSBC downgrades Pfizer to Hold after sigvotatug vedotin Phase 3 miss; BMS Krazati confirmatory study fails in CRC as Roche divarasib wins KRAS Phase 3; FDA closes H1 2026 with 23 novel approvals; Casgevy label expands to ages 2+; Roche licenses breast cancer asset from Astex Visit us at www.thepharmacloseput.com pharma, biotech, FDA, clinical trials, drug approvals, Vertex, Crinetics, Novartis, Myricx Bio, Pfizer, KRAS G12C, endocrinology

Enbrel Price Cap Blocked: One Ruling That Could Reshape States Drug Pricing

Federal court blocks Colorado's 70% price cap on Enbrel — ruling could shut down state drug pricing laws nationwide. Plus: Casgevy label expansion to age 2 for SCD/TDT sends CRISPR Therapeutics surging 8%. Moderna mFLUSIVA rally hits 70% ahead of August 5 FDA decision. AstraZeneca-CSPC $1.7B kidney deal; Celea raises $180M for IPF; Orca Bio prices Tregzi at $428K. Visit us at www.thepharmcloseout.com pharma, biotech, FDA, clinical trials, drug approvals, Enbrel, Amgen, drug pricing, Casgevy, CRISPR Therapeutics, Moderna, sickle cell disease

Roche Divarasib Beats Both KRAS G12C Rivals in Phase 3 Lung Cancer Study

Roche's divarasib beats both KRAS G12C rivals on PFS and OS in head-to-head Phase 3, hitting survival significance at interim. AstraZeneca returns to CSPC in a $1.7B siRNA kidney disease deal; Abivax surges on $920M raise and cleared obefazimod cancer concerns; Ipsen acquires Memo Therapeutics; BridgeBio secures $1B; Scribe Therapeutics files for IPO; FDA CBER gene therapy leadership transition. Visit us at www.thepharmacloseout.com Roche's divarasib beats both KRAS G12C rivals on PFS and OS in head-to-head Phase 3, hitting survival significance at interim. AstraZeneca returns to CSPC in a $1.7B siRNA kidney disease deal; Abivax surges on $920M raise and cleared obefazimod cancer concerns; Ipsen acquires Memo Therapeutics; BridgeBio secures $1B; Scribe Therapeutics files for IPO; FDA CBER gene therapy leadership transition.