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FDA cell and gene therapy leadership shakeup
FDA’s acting director of cell and gene therapies Vijay Kumar is stepping down from his role overseeing CBER’s Office of Therapeutic Products, according to statements reported by Endpoints News and...
FDA PreCheck pilot expands for onshoring and plant reviews
The FDA launched and expanded its PreCheck Pilot Program for manufacturing plants, selecting companies including Eli Lilly, Regeneron, Cellares, and Fujifilm to participate. The program is...
Abivax ulcerative colitis data eases cancer concerns
Abivax provided additional data for its ulcerative colitis drug obefazimod, aiming to address cancer safety concerns that had rattled investors earlier in June. The company said the updated safety...
Amgen’s Tavneos pivotal data retracted by NEJM
The New England Journal of Medicine retracted a pivotal phase 3 article for Amgen’s Tavneos (avacopan) after academic authors reported that primary endpoint assessments in nine patients were...
CAR T trial enabling: Imviva gains FDA IDE for ClonoSeq MRD
Imviva Biotech received an FDA investigational device exemption (IDE) to use Adaptive Bio-Technologies’ ClonoSeq MRD assay in its TENACITY-01 Phase Ib/II trial of CTD402, an allogeneic anti-CD7...
Dealmaking: Ipsen buys Kartos for p53-restoring myelofibrosis therapy
Ipsen agreed to acquire Kartos Therapeutics for $450 million upfront, with potential milestones up to $1.3 billion, securing navtemadlin—an oral MDM2 inhibitor aimed at restoring p53 function....
Beeline immunology funding boost
Bristol Myers Squibb spinout Beeline Medicines raised an additional $126.3 million through a Series A extension, bringing total capital to $426.3 million. The funding supports scaling its immune...
Lymphoma progress: Epkinly combination win in Epcore DLBCL-4
AbbVie and Genmab reported positive Phase 3 results for Epkinly (elacestrant?) in combination with lenalidomide in diffuse large B-cell lymphoma, with the Epcore DLBCL-4 trial meeting its primary...
Oncology diagnostics: Aveta selects Natera Signatera for Phase III MRD endpoint
Aveta Biomics selected Natera’s Signatera ctDNA assay to measure minimal residual disease in its Phase 3 trial of APG-157, an oral immunotherapy program targeting locally advanced head and neck...
Core platform competition: Roche launches Axelios 1 sequencing platform
Roche launched its Axelios 1 next-generation sequencing platform to compete directly with Illumina’s installed base, aiming to address bottlenecks around accuracy, speed, flexibility, scalability,...
US probes foreign trial practices for major drugmakers
A U.S. House committee has opened an investigation into Merck and AbbVie over their China clinical trial practices, according to the latest report on the probe. The inquiry targets the use of...
FDA gene therapy regulator exit triggers leadership transition
Vijay Kumar, the acting FDA gene-therapy regulator overseeing cell and gene therapies within CBER’s Office of Therapeutic Products, is stepping down from the role after roughly a year in the...
Controversy expands around Amgen’s Tavneos clinical evidence
The New England Journal of Medicine has retracted Tavneos (avacopan) pivotal phase 3 study data after an FDA investigation concluded primary endpoint assessments were readjudicated after database...
Abivax reassures on ulcerative colitis safety after cancer signals
Abivax moved to calm investor concern over its ulcerative colitis candidate obefazimod by disclosing additional safety data, indicating cancer cases in a Phase 3 setting were within the expected...
New antibody-drug combo readout strengthens Epkinly strategy in DLBCL
AbbVie and Genmab touted results from a Phase 3 combination study for Epkinly (epcoritamab) after a prior monotherapy setback in diffuse large B-cell lymphoma. In the Epcore DLBCL-4 trial, Epkinly...
FDA greenlights Viridian’s Lumvoa for thyroid eye disease—competition to Tepezza
The FDA cleared Viridian Therapeutics’ IGF-1R antagonist Lumvoa (veligrotug-vvze) for thyroid eye disease, including both active and chronic phases, setting up immediate competition with Amgen’s...
Merger reshapes royalty and late-stage assets—Zymeworks buys Theravance
Zymeworks agreed to acquire Theravance Biopharma in a $929 million deal, paying $17 per share in cash. The transaction is designed to diversify Zymeworks’ revenue and strengthen its balance sheet...
Ipsen takes Kartos for MDM2 inhibitor navtemadlin in myelofibrosis
Ipsen agreed to acquire Kartos Therapeutics for $450 million upfront, with potential milestones that could total $1.75 billion, to expand its late-stage oncology portfolio. The deal centers on...
AI-built immunology biotech Beeline expands Series A runway
Beeline Medicines raised an additional $126.3 million via a Series A extension, bringing total funding to $426.3 million. The cash will support development of its autoimmune pipeline, including...
Diagnostics and sequencing tools: new FDA submissions and commercial platform launches
BioMérieux submitted updated gastrointestinal FilmArray panels to the FDA for 510(k) review, updating pathogen coverage and norovirus detection while targeting faster time-to-results. The GI1.1...