Get the Daily Brief
Latest Biotech News
Lilly and Biogen’s blockbuster M&A reshapes sleep and immunology portfolios
Eli Lilly agreed to acquire Centessa Pharmaceuticals for about $6.3 billion upfront, adding an orexin receptor 2 (OX2R) agonist portfolio aimed at narcolepsy and other sleep-wake disorders....
FDA regulatory scrutiny tightens around therapies with safety signals
The FDA flagged serious safety concerns tied to Amgen’s Tavneos (tavneos, avacopan) in its latest regulatory disclosure, identifying more than 70 cases of severe liver injury and eight deaths...
AstraZeneca’s rare-disease program stumbles in pivotal testing
AstraZeneca’s experimental enzyme replacement therapy for hypophosphatasia posted mixed late-stage trial outcomes across three pivotal studies, according to reporting. The treatment, efzimfotase...
Viridian’s thyroid eye disease Phase 3 clears the bar on secondary questions but triggers investor debate
Viridian Therapeutics reported positive Phase 3 efficacy for elegrobart (IGF-1R monoclonal antibody) in active thyroid eye disease, meeting the primary endpoint in its Reveal-1 trial. The company...
Merck accelerates inflammatory-biology target discovery with Quotient collaboration
Merck & Co. will use Quotient Therapeutics’ somatic genomics platform to discover novel drug targets in inflammatory bowel disease, in a deal that could generate up to $2.2 billion for the...
Antibody discovery platform deal: Merck funds AI-first Infinimmune library expansion
Merck entered a new antibody discovery agreement with Infinimmune, a startup using AI to mine human immune cells for candidates. The pact could be worth up to $838 million in upfront and...
AstraZeneca/Insilico style AI expansion: Lilly expands AI drug discovery via multibillion-dollar Insilico deal
Eli Lilly is expanding its AI-driven drug discovery collaboration with Insilico Medicine in a deal valued up to $2.75 billion, extending a multi-year partnership that is intended to generate novel...
RNA therapeutics industrialization: first clinical trial for a reusable tRNA platform
Alltrna received clearance to begin its first clinical trial, marking a step toward developing a reusable class of RNA therapeutics built around tRNA biology. The company’s approach is designed so...
Place-of-care cell and gene therapy manufacturing alliance targets cost and scalability
A new partnership brings together Trenchant BioSystems technology, University of Massachusetts Chan Medical School expertise, and Caring Cross access programs to develop a place-of-care HSC...
FDA and health systems keep pushing multiplex diagnostics closer to point of care
Baebies said it obtained 510(k) clearance and a CLIA waiver for a triplex respiratory test on its Finder multifunction point-of-care system, combining molecular testing with additional cleared...
Big Pharma buyouts reshape neuroscience and immunology
Eli Lilly agreed to acquire Centessa Pharmaceuticals for about $6.3 billion in up-front cash, plus up to $1.5 billion through contingent value rights tied to regulatory milestones. The deal gives...
Merck expands with somatic genomics push in inflammatory bowel disease
Merck & Co. will apply Quotient Therapeutics’ somatic genomics platform to identify novel drug targets in inflammatory bowel disease (IBD) under a collaboration that could generate up to $2.2...
FDA safety signal lights up Amgen’s Tavneos liver injury risk
The U.S. FDA identified eight deaths associated with Amgen’s autoimmune treatment Tavneos and flagged more than 70 cases of severe liver injury. Amgen said it previously notified the agency about...
Clinical trial volatility: Vanda’s tradipitant hurdles in gastroparesis
Vanda Pharmaceuticals’ tradipitant cleared a major Phase 2 hurdle tied to preventing nausea and vomiting associated with GLP-1 receptor agonists, but U.S. FDA review outcomes are constraining its...
AstraZeneca’s rare disease miss underscores late-stage risk
AstraZeneca’s experimental enzyme replacement therapy efzimfotase alfa delivered mixed results across three late-stage trials targeting hypophosphatasia, a rare genetic condition that can lead to...
US approval signals: CAR-T breakthrough designation for Wugen program
Washington University School of Medicine’s CAR-T therapy was granted Breakthrough Therapy designation by the U.S. FDA, licensed to Wugen. The move points to potential expedited development and...
Clinical-stage dermatology win for Simcere’s rademikibart
Simcere Pharmaceutical Group’s monoclonal antibody rademikibart (CBP-201) met its primary endpoint in a Chinese Phase 3 study for adults and adolescents with moderate to severe atopic dermatitis....
Diagnostics push: Baebies gets 510(k) and CLIA waiver for multiplex triplex respiratory testing
Baebies obtained 510(k) clearance and a CLIA waiver for a triplex respiratory test on its Finder point-of-care system, enabling molecular testing alongside other cleared modalities. The instrument...
Genomics-and-data dealmaking continues: ICON partners with Advarra for trial site network integration
ICON partnered with IRB and clinical trial operations provider Advarra to build an integrated, AI-driven site network model aimed at reducing trial startup delays. The arrangement combines...
Investment and funding: Ambrosia raises $100M for oral GLP-1 small molecule
Ambrosia Biosciences, a Denver-area biotech, secured $100 million in funding to develop an oral small-molecule GLP-1 candidate in one of the most competitive metabolic markets. The financing...