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

14 min · Gisteren
aflevering July 07, 2026| Vera's TRUTAKNA Wins FDA Nod: The eGFR Readout That Decides the IgAN Race artwork

Beschrijving

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

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

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

9 jul 202610 min
aflevering Roche Divarasib Beats Both KRAS G12C Rivals in Phase 3 Lung Cancer Study artwork

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.

4 jul 202610 min