Get the Daily Brief
Latest Biotech News
Regulatory action – Tavneos withdrawal and CHMP escalation
The EMA has joined the FDA in moving toward withdrawal of Amgen’s Tavneos (avacopan) after both agencies flagged data integrity problems. A CHMP review recommended revoking the drug’s EU marketing...
FDA advisory pressure – Replimune and peptide controversy return to adcomms
FDA advisory committees are set to revisit contested applications under renewed emphasis on adcomms, with meetings scheduled that will test the agency’s post-leadership-shakeup approach....
Clinical/regulatory – Replimune’s third RP1 try gets new FDA decision timeline
Replimune has received an early August decision date for its resubmission of RP1, setting up a potential regulatory inflection after two prior FDA rejections for advanced melanoma. The FDA...
FDA approvals – Viridian’s veligrotug launches competition with Amgen’s Tepezza
The FDA approved Viridian Therapeutics’ thyroid eye disease drug veligrotug, to be marketed as Lumvoa, setting up direct competition with Amgen’s Tepezza. The approval opens a new pricing and...
FDA approval – Ionis expands Tryngolza beyond rare disorder
Ionis Pharmaceuticals’ Tryngolza (olezarsen) gained wider U.S. approval for severe hypertriglyceridemia, moving the therapy from a rare formulation into a more prevalent-market label. The FDA...
Market access and pricing policy – 340B reform pressure returns
Sen. Bill Cassidy introduced a bill aimed at restricting the 340B drug discount program amid renewed scrutiny of how the program is used by nonprofit hospitals. Cassidy’s proposal follows years of...
Oncology competition – Gilead’s Trodelvy expands first-line TNBC positioning
The FDA expanded Gilead’s Trodelvy label in first-line triple-negative breast cancer, allowing use regardless of PD-L1 status and intensifying the TROP2 ADC competitive set. The new approval...
Dealmaking and consolidation – Merck KGaA to acquire Bio-Techne for $11.3B
Merck KGaA agreed to buy Bio-Techne in a roughly $11.3 billion deal, positioning the German conglomerate to expand life science tools and multi-omics capabilities across discovery and...
Antibody discovery collaboration – Immunai and Boehringer Ingelheim expand T-cell target search
Immunai signed a research collaboration with Boehringer Ingelheim valued at up to $15 million to identify T-cell dysfunction patterns for oncology and autoimmune target discovery. The multi-year...
Scientific integrity – Nature Medicine retracts China lung cancer timing study
Nature Medicine retracted a high-profile Chinese lung cancer paper that reported survival gains when immunotherapy was administered before 3 p.m., citing loss of confidence in the integrity of the...
Regulatory action: Tavneos withdrawn over data integrity
The European Medicines Agency (EMA) moved to revoke Amgen’s Tavneos (avacopan) after its Committee for Medicinal Products for Human Use (CHMP) concluded that the original approval basis used...
FDA panel timeline: Replimune returns to advisory committee
The FDA announced new advisory committee meetings under leadership changes, with Replimune and Capricor among the programs resurfacing after earlier controversy. Replimune’s oncolytic...
Regulatory: FDA approval lifts Tryngolza into broader cardiometabolic use
Ionis Pharmaceuticals won wider U.S. FDA approval for Tryngolza (olezarsen), moving the therapy beyond its rare form of familial chylomicronemia syndrome and into severe hypertriglyceridemia. The...
Therapy approval: Gilead’s Trodelvy expands first-line label in TNBC
The FDA granted Gilead Sciences approval to use Trodelvy (sacituzumab govitecan-hziy) in first-line triple-negative breast cancer (TNBC) regardless of PD-L1 status. The updated label now covers...
Clinical research: Intravesical MUC16 CAR T shows tumor control preclinically
Researchers at Weill Cornell Medicine and Roswell Park Comprehensive Cancer Center reported preclinical results supporting intravesical delivery of MUC16-targeting CAR T cells to control bladder...
Oncology innovation: AI framework nominates next-gen solid tumor CAR T target
A human-in-the-loop AI framework described in Cell is reshaping how researchers search for solid-tumor CAR T targets, with GPNMB emerging as a lead candidate after computational filtering. The...
Drug discovery platform: Protein transfer enables antibiotic persistence
Baylor College of Medicine researchers reported in Science that antibiotics can trigger protein sharing between bacterial populations, enhancing survival of persister cells during...
Diagnostics/monitoring: Natera Prospera dd-cfDNA added to Phase III kidney transplant trial
Natera and Eledon Pharmaceuticals partnered to incorporate Natera’s Prospera donor-derived cell-free DNA (dd-cfDNA) test into a global Phase III kidney transplant trial. Prospera will serve as...
Big deal: Merck KGaA to acquire Bio-Techne for $11.3B
Merck KGaA agreed to buy Bio-Techne for roughly $11.3 billion, positioning the combined company to expand life-sciences tools, analytics, and workflow capabilities across discovery through...
Emerging therapy platform: Base-editing CAR T via non-viral delivery moves closer
Circio and Tcelltech announced a collaboration to build next-generation in vivo CAR-T and TCR-T approaches by combining Circio’s circVec circular RNA expression technology with Tcelltech’s...