Get the Daily Brief
Latest Biotech News
Regulatory action: Tavneos withdrawn over data integrity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...
Regulatory action: Tavneos effectiveness questioned by EMA
The European Medicines Agency’s committee recommended withdrawing Amgen’s Tavneos (avacopan) from the European market, citing “incorrect and misleading” data provided during the marketing...
FDA approval expands competitive landscape for solid-tumor ADCs in TNBC
The FDA expanded Gilead’s Trodelvy label to allow use as a first-line treatment for triple-negative breast cancer regardless of PD-L1 status, strengthening the company’s position in the...
Clinical trial regulator path: Replimune’s RP1 gets resubmission decision timeline
Replimune secured an early August regulatory decision date for its third attempt at RP1, an oncolytic immunotherapy for advanced melanoma that has been rejected twice by the FDA. The FDA accepted...
New therapy signal: Intravesical CAR T targets MUC16 in bladder cancer model
Weill Cornell Medicine and Roswell Park Comprehensive Cancer Center reported preclinical results showing intravesical delivery of MUC16-targeting CAR T cells can control bladder tumors in mice....
Company launch: Bionyra raises to build next-gen inflammatory biologics platform
Bionyra Pharma emerged from stealth after raising an oversubscribed $165 million Series A to develop next-generation biologics for severe immunological and inflammatory diseases. The...
Branded drugmaker competition: Viridian’s veligrotug approved for thyroid eye disease
The FDA approved Viridian Therapeutics’ thyroid eye disease treatment veligrotug, to be marketed as Lumvoa, setting up direct competition with Amgen’s Tepezza. The approval adds a second...
Funding and M&A: Merck KGaA agrees to buy Bio-Techne for $11.3B
Merck KGaA agreed to acquire Bio-Techne in a deal valued at about $11.3 billion, expanding the acquirer’s life science tools, diagnostics, and multiomics offerings. The all-cash offer is $73 per...
Regulatory and rights: RQ Bio expands funding for long-acting flu antibody prophylaxis
RQ Bio secured an oversubscribed $115 million Series A to advance its single-dose long-acting antibody prophylaxis program for influenza in high-risk and immunocompromised populations. The lead...
Class action: Natera hit with lawsuit alleging misleading PGT-A genetic testing claims
Natera is facing a class action lawsuit alleging misleading marketing of its preimplantation genetic testing for aneuploidy (PGT-A) through its Spectrum PGT-A test. Plaintiffs Melissa Klein and...
Regulatory actions in rare disease and oncology
European regulators moved to pull Amgen’s Tavneos from the market after an assessment found the data submitted for the application “incorrect and misleading.” The EMA recommendation follows a...