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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...
Regulatory leadership and FDA gene therapy capacity
FDA’s top gene-therapy regulator, Vijay Kumar, is stepping down from his role as acting director of the Office of Tissues and Gene Therapies within CBER, according to an email obtained by STAT....
Regulatory process shifts in China clinical trials
China’s National Medical Products Administration updated Good Clinical Practice rules that will take effect in September, emphasizing clinical trial data governance, transparency, and participant...
Acquisition reshapes blood cancer pipeline—Ipsen takes navtemadlin platform
Ipsen agreed to acquire Kartos Therapeutics for $450 million upfront and up to $1.75 billion total, securing late-stage blood cancer asset navtemadlin, a p53-restoring oral MDM2 inhibitor. The...
Corporate funding signals for epigenome editing startup
Epitome Therapeutics, an EMBL spinoff focused on targeted epigenome editing, launched with €4 million in capital to build its Cadence platform and move programs toward candidate selection. The...
Next-generation partner deals in T-cell engaging immunotherapy (TCEs)
Boulevard Bio is paying $20 million upfront to acquire global rights to a trispecific T-cell engager for autoimmune diseases from Metis TechBio, with potential payments totaling up to $1.6 billion...
Phase 3 readout expands evidence base for a pediatric rare disease drug
BridgeBio Pharma-supported oral infigratinib delivered statistically significant improvements versus placebo in a Phase 3 trial in children with achondroplasia, according to a June 28 publication...
FDA approval opens new competitive chapter in thyroid eye disease
The FDA approved Viridian Therapeutics’ Lumvoa (veligrotug-vvze), an IGF-1R antagonist, for thyroid eye disease, clearing the drug for both active and chronic phases. Viridian said it will launch...
Business development deal—Insilico and SK Biopharmaceuticals expand neuroimmune AI pipeline
Insilico Medicine and SK Biopharmaceuticals agreed on an AI-based neuroimmune drug discovery collaboration that could generate up to $2.5 billion. Insilico will apply its Pharma.AI platform...
Immunology pipeline gets cash—Beeline expands series A after BMS backing
Beeline Medicines, backed by Bristol Myers Squibb and investors including Bain Capital, added $126.3 million in an extension to its Series A after the company emerged from stealth earlier this...
Scientific and operational integrity risk in antibody validation data
Researchers escalated concerns after finding evidence of altered antibody validation images in vendor catalog data, sparking broader backlash against Thermo Fisher Scientific’s online antibody...