Get the Daily Brief
Latest Biotech News
FDA clears Rocket gene therapy and grants a rare pediatric priority review voucher
FDA approved Rocket Pharmaceuticals’ gene therapy Kresladi (marnetegragene autotemcel) for leukocyte adhesion deficiency type I, according to the company’s March update. Rocket said the...
TriNetX and Regeneron sign a data linkage deal spanning genomic and proteomic cohorts
TriNetX will provide Regeneron exclusive, secure, licensed access to de-identified real-world health data covering about 300 million individuals, with TriNetX linking genomic and proteomic...
Alto’s Phase 2 miss forces program shelving in cognitive impairment in schizophrenia
Alto Neuroscience shelved its schizophrenia-related cognitive impairment program after a Phase 2 failure of its PDE4 inhibitor, the company said. The decision pauses further development and...
Trump revives 100% pharma tariffs with carveouts and manufacturing-linked reductions
The Trump administration announced 100% tariffs on imported brand-name drugs, while building in carveouts for drugmakers that strike most-favored nation-style agreements or pledge domestic...
Rocket gene therapy PRV and other pipeline signals land alongside new FDA PDUFA schedule
FDA’s April calendar includes remaining PDUFA decisions, including a pending call on an oncolytic virus and updates tied to delayed biologics. Replimune’s oncolytic virus Vusolimogen oderparepvec...
Ambrosia raises fresh Series B to fund oral obesity pipeline and moves toward Phase 1
Ambrosia Biosciences secured an oversubscribed $100 million Series B to advance its oral obesity drug pipeline, including its lead oral small-molecule GLP-1 candidate. The company plans to move...
Syneron closes $150M Series B to scale macrocyclic peptide discovery platform
Syneron Bio closed a $150 million Series B to support development of its macrocyclic peptide discovery platform. The company previously raised nearly $100 million and also secured a...
Biogen moves into nephrology via $5.6B acquisition of Apellis Pharmaceuticals
Biogen agreed to acquire Apellis Pharmaceuticals for $5.6 billion, aiming to accelerate its nephrology expansion. The deal comes after Biogen’s immunology push and is tied to an HI-Bio drug in...
FDA clears investigational sequencing platform rollout through AIM/organ models narrative
The industry spotlight continued on FDA’s evolving approach to reduce reliance on animal efficacy proof-of-concept, with emphasis on organoid-based preclinical evidence. SillaJen’s vascularized...
Injectable hemostatic microgels show at least 50% bleeding reduction in neonate surgery models
Researchers at UNC–NC State developed an injectable microgel designed to reduce bleeding in infants undergoing surgery, reporting at least a 50% reduction in an animal model. The hemostatic...
Regulatory approvals and expansion of gene therapy marketing pathways
FDA’s March approval of Rocket Pharmaceuticals’ gene therapy Kresladi (marne-cel) marked a notable regulatory milestone, with the drug earning a rare pediatric disease priority review voucher....
Funding to advance oral obesity and peptide platform programs
Ambrosia Biosciences raised an oversubscribed $100 million Series B to advance its preclinical oral obesity pipeline into Phase I. The round co-led by Blue Owl Healthcare Opportunities, Redmile...
Clinical progress for oncology supportive care to cut EGFR-mutant NSCLC dermatologic toxicity
Interim results from the phase II COCOON trial showed a reduction in dermatologic adverse events for patients with EGFR-mutant non-small cell lung cancer (NSCLC) when proactive skincare is added...
AI and multi-omics data deals for drug discovery and development
TriNetX will link with Regeneron to provide the company exclusive, secure access to de-identified health data from approximately 300 million individuals, aimed at supporting drug discovery and...
FDA and global review reforms around new approach methodologies (NAMs) for toxicity testing
The European Medicines Agency (EMA) gave initial endorsement to a new approach methodology that replaces live animal controls in early toxicity testing with “virtual counterparts” derived from...
Massive biopharma M&A reshaping biotech sentiment and quarter-end momentum
M&A drove a rebound in biotech market performance heading into Q2, with Eli Lilly’s acquisition of Centessa Pharma and Biogen’s purchase of Apellis Pharma cited as key deal catalysts. The stock...
Regulatory and competitive battle in oral GLP-1 weight-loss drugs
The FDA’s approval of Eli Lilly’s oral weight-loss drug Foundayo has set up a direct competitive push from Novo Nordisk to defend oral Wegovy. Novo highlighted differences in weight-loss outcomes,...
Court ruling closes a CRISPR patent battle and potentially clears guide-RNA modification IP barriers
The U.S. Supreme Court declined to hear an appeal from Agilent Technologies over the invalidation of two CRISPR-related patents tied to chemical modifications of guide RNAs used in CRISPR-Cas...
Biologics manufacturing and supply agreements for late-stage PD-L1 antibody candidate
ImmuneOncia Therapeutics and Lonza signed a manufacturing agreement for late-stage clinical supply of Danburstotug (IMC-001), a fully human PD-L1 immune checkpoint antibody in clinical...
Biomarker diagnostics funding for non-invasive endometriosis testing
Northwell Health’s Feinstein Institutes for Medical Research received a $500,000 RADx Tech award to develop a non-invasive endometriosis biomarker test using menstrual samples. The project, part...