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GSK wins FDA nod – twice‑yearly asthma biologic
The FDA cleared GSK’s depemokimab (Exdensur) as an add‑on maintenance therapy for patients aged 12 and older with severe eosinophilic asthma. The agency’s approval follows positive SWIFT‑1 and...
DBV rebounds: Viaskin patch clears Phase III in kids
DBV Technologies reported that its Viaskin peanut allergy patch met the primary endpoint in the pivotal Vitesse Phase III trial in children aged 4–7, with 46.6% responders on active treatment...
Personalis MRD assay flags immunotherapy responders – study
A multicenter study published in Clinical Cancer Research shows Personalis’ NeXT Personal whole‑genome, tumor‑informed MRD assay predicted early immunotherapy responses and survival across...
Addition emerges with PRINT tech — deep pockets follow
Addition Therapeutics unveiled its PRINT gene‑insertion platform after emerging from stealth with major backing and a plan to develop insertional gene therapies for chronic and rare disease. The...
BMS bets on Harbour’s antibody engine – big upfront, big upside
Bristol Myers Squibb struck a multiyear collaboration with Harbour BioMed aimed at multispecific antibody discovery and development, a deal that includes about $90 million up front and could...
Yarrow/RTW grabs China antibody for autoimmune thyroid disease
RTW‑backed Yarrow Bioscience licensed ex‑China rights to GS‑098, a thyroid‑stimulating hormone receptor (TSHR) antibody developed by Shanghai Scizeng/GenSci, in a deal that could reach $1.37...
AI drug design and trial AI gets fresh capital — Chai and Valinor fundraises
Chai Discovery closed a $130 million Series B to accelerate its Chai‑2 AI platform for de novo antibody design, citing double‑digit success rates in early wet‑lab validation and expanded ambitions...
FDA and industry feel the squeeze — warning letters and looser RWE rules
Regulatory pressure and policy shifts hit the headlines this week as the FDA issued a warning letter to Novo Nordisk over quality issues at a Catalent‑acquired Bloomington, IN, manufacturing site,...
XOMA to buy Generation Bio — royalty player expands nucleic‑acid portfolio
XOMA Royalty announced a takeover of Generation Bio in a cash tender offer valuing shares at $4.29 each, a move that brings Generation Bio’s cell‑targeted lipid nanoparticle (ctLNP) delivery...
Two IND clears: Recludix STAT6 inhibitor and Nchroma’s HBV candidate
Recludix Pharma secured IND clearance from the FDA to advance REX‑8756 (SAR‑448755), an oral STAT6 inhibitor, into first‑in‑human phase I testing for inflammatory diseases. The small‑molecule...
Padcev–Keytruda extends survival in Phase 3: Pfizer, Astellas, Merck to seek approvals
A Phase 3 trial showed that combining Pfizer and Astellas’s antibody–drug conjugate Padcev (enfortumab vedotin) with Merck’s Keytruda (pembrolizumab) improved overall survival for a subset of...
RTW’s Yarrow goes public via reverse merger – RTW injects cash as it bets on a China antibody
RTW Investments is taking its Yarrow Bioscience vehicle public through a reverse merger with Vyne Therapeutics and plans a substantial cash infusion to scale the biotech. Yarrow will acquire...
Yarrow picks China antibody in $1.37B pact: GS‑098 ex‑China rights land with $70M up front
Yarrow Bioscience, backed by RTW Investments, struck a near‑$1.37 billion deal to secure ex‑China rights to GS‑098, a TSH receptor antibody developed by Shanghai Scizeng (GenSci). The agreement...
Addition emerges with $100M — UC‑backed startup unveils PRINT delivery claims
University of California spinout Addition Therapeutics emerged from stealth with roughly $100M in financing to commercialize a platform it says enables improved genetic medicine delivery. The...
Chai Discovery raises $130M: AI antibody designer scales de novo platform
Chai Discovery closed a $130M Series B to scale its Chai‑2 generative platform for de novo antibody design, the company said. Chai reported double‑digit experimental success rates in early...
Sanofi signs $1.04B pact for ADEL’s tau antibody: $80M up front
Sanofi licensed ADEL’s tau‑targeting antibody ADEL‑Y01 in a deal worth up to $1.04 billion, with $80 million paid up front and potential milestone and royalty payments thereafter. The asset is in...
FDA eases the rules on device RWE — and signals broader real‑world data use
The U.S. Food and Drug Administration announced a less restrictive stance toward device premarket submissions that use real‑world evidence (RWE) lacking patient‑level data, potentially lowering...
FDA clears Enhertu for first‑line HER2 disease — diagnostics follow with Roche approvals
The FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) combined with pertuzumab as a first‑line treatment for unresectable or metastatic HER2‑positive breast cancer....
GSK seeks FDA label change for leucovorin to treat developmental disability tied to autism
GlaxoSmithKline filed for a new FDA label for leucovorin, asking regulators to approve the drug for a developmental disability the company says is linked to autism spectrum disorder. GSK confirmed...
FDA warning letter lands on Novo Nordisk over Catalent‑acquired plant
The FDA issued a warning letter to Novo Nordisk over manufacturing problems at a Bloomington, Indiana factory it acquired from Catalent, asking the drugmaker to analyze all sites purchased in the...