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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...
Nchroma wins Hong Kong clearance for HBV candidate CRMA‑1001 — First‑in‑human trial set
Nchroma Bio received clinical trial authorization in Hong Kong to start a first‑in‑human Phase I/II study of CRMA‑1001 for chronic hepatitis B virus infection, with dosing expected early next...
Yarrow picks GenSci TSHR asset: $1.37B ex‑China deal
Yarrow Bioscience agreed to license ex‑China rights to GS‑098, a thyroid‑stimulating hormone receptor (TSHR) antibody developed by Shanghai Scizeng/GenSci, in a deal that could be worth roughly...
Sanofi licenses ADEL’s tau antibody — $80M now, $1.04B possible
Sanofi struck a global licensing agreement for ADEL‑Y01, a tau‑targeting monoclonal antibody from ADEL Inc., paying $80 million upfront and up to $1.04 billion in total biobucks. The candidate is...
Bristol Myers taps Harbour BioMed: antibody discovery pact up to $1.1B
Bristol Myers Squibb signed a multiyear research and discovery collaboration with Harbour BioMed to accelerate antibody discovery and development, with potential payments that can reach $1.1...
AI drug R&D draws cash: Chai $130M Series B; Valinor $13M seed
Two AI‑focused startups raised fresh capital to scale computational drug discovery and trial design. Chai Discovery closed a $130 million Series B to expand Chai‑2, its de‑novo antibody generative...
Addition Therapeutics emerges with gene‑insertion tech and $100M+
Addition Therapeutics, a UC‑Berkeley spinout, surfaced from stealth with more than $100 million in financing to back a new RNA‑based gene insertion approach (branded as PRINT in some coverage)....