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Clinical updates and financing for obesity triple-agonist pipeline
Kailera reported early Phase 1 dosing results for its investigational triple-hormone obesity drug KAI-4729, showing double-digit weight loss in a small China study. The company said a cohort of 12...
Drugmaker M&A deal: AbbVie gains FDA approval for ADC tied to ImmunoGen purchase
AbbVie received FDA approval for an ultra-rare blood cancer antibody-drug conjugate it acquired through its $10.1 billion buyout of ImmunoGen. The approval brings another asset from the ImmunoGen...
Europe payer decision for Genmab’s cervical cancer ADC
The UK’s NICE approved reimbursement for Genmab’s cervical cancer ADC tisotumab vedotin (Tivdak), reversing an earlier draft stance that raised cost-effectiveness concerns. NICE said the company...
Licensing deal: Hansa Biopharma expands Idefirix access across Europe and MENA
Hansa Biopharma agreed a €115 million ($133.5 million) licensing deal with SERB Pharmaceuticals to expand access to imlifidase (Idefirix) for kidney transplant desensitization across Europe and...
Regenerative science and manufacturing economics: ARPA-H program targets room-temperature biologic storage
ARPA-H highlighted efforts to reduce the cold-chain burden of biologics by funding BioStabilization Systems (BoSS), a program aimed at storing certain cell and gene therapy products at room...
Clinical and diagnostic platform: Verici Dx validates pre-transplant kidney rejection risk signature
Verici Dx validated a pre-transplant diagnostic test designed to predict acute kidney rejection risk before transplantation. The company’s Pre-Transplant Risk Assessment (PTRA) uses a 29-gene RNA...
Cell identity mapping alliance: Parse and bit.bio combine single-cell platforms
Parse Biosciences and bit.bio announced a collaboration to build a transcription factor-driven cell identity map, covering both cell state and cell fate. The companies said they will combine...
Biotech financing: ClearNote Health closes Series D for early cancer detection tests
ClearNote Health raised $52 million in Series D financing, bringing total funding to more than $185 million. Founding investor Mattias Westman led the round with participation including Sandy...
Hepatitis B: GSK’s bepirovirsen Phase 3 readout
GSK disclosed detailed Phase 3 results for bepirovirsen, a chronic hepatitis B therapy it licensed from Ionis Pharmaceuticals, with regulatory reviews underway in four markets including the U.S....
Dermatology M&A financing: Apogee’s Blackstone-backed path to Phase 3
Apogee Therapeutics secured up to $1.3 billion in non-dilutive financing from Blackstone Life Sciences to advance zumilokibart (zumi) into Phase 3 for atopic dermatitis. The funding package...
FDA decision timing: AstraZeneca’s camizestrant breast cancer pill delayed
The FDA pushed back its decision date on AstraZeneca’s oral SERD camizestrant after a negative advisory committee vote tied to SERENA-6. FDA reviewers requested additional analyses to support the...
Obesity drug competition: Kailera’s Phase 1 “triple-G” obesity data
Kailera reported early Phase 1 dosing results for KAI-4729, its triple-hormone obesity candidate developed with partner Hengrui Pharmaceuticals in China. The biotech said a 12-week dose-escalation...
Cardiovascular biotech pipeline: Kardigan files for IPO
Kardigan filed for a U.S. IPO with three late-stage cardiovascular programs targeting genetic dilated cardiomyopathy, calcific aortic valve stenosis, and severe hypertension. The company said it...
Vaccines and business development: Lilly buys three vaccine developers
Eli Lilly agreed to acquire three vaccine makers—Vaccine Company Inc., Curevo, and LimmaTech Biologics—in deals totaling up to nearly $4 billion. The transactions expand Lilly’s infectious disease...
Oncology diagnostics: Verici Dx validates 29-gene pre-transplant kidney rejection risk test
Verici Dx validated a 29-gene immune RNA expression signature to predict acute kidney rejection risk before transplantation, independent of donor factors and standard clinical risk markers. The...
AI + oncology targeting: UCSD’s MutationProjector links co-dependent tumor mutations to response
Researchers led by UC San Diego and Trey Ideker unveiled MutationProjector, an AI-enabled tumor genome foundation model designed to interpret mutational landscapes and predict therapy responses by...
Medical device compliance: Insulet initiates voluntary correction on Omnipod insulin pump pods
Insulet initiated a voluntary medical device correction affecting Omnipod insulin pump pods after identifying a manufacturing issue that could lead to insulin leakage and under-delivery of doses...
Regenerative medicine platform: Parse Biosciences and bit.bio build transcription factor-driven cell identity map
Parse Biosciences, a Qiagen unit, partnered with bit.bio to build a map of transcription factor-driven cell identity, spanning cell state and cell fate. The collaboration combines bit.bio’s cell...
Hepatitis B drug late-stage readouts
GSK disclosed detailed positive Phase 3 results for bepirovirsen, a chronic hepatitis B therapy it licensed from Ionis Pharmaceuticals. The company shared outcomes across two late-stage trials,...
AI sepsis monitoring gains FDA clearance
Bayesian Health announced it became the first company to receive FDA clearance for a continuous AI-powered sepsis monitoring system. The clearance follows years of clinical validation work and...