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AI and biosecurity policy scrutiny
A U.S. House hearing put “biosecurity” guardrails for AI-driven biotech under the microscope, with lawmakers warning that advanced models lower the barriers to misuse. Rep. Rick McCormick (R-Ga.)...
Big pharma deals for platform technologies
Novartis agreed to pay $125 million to acquire a blood-brain barrier delivery platform from Sironax, giving Novartis global rights to a technology designed to transport multiple drug modalities...
Clinical trial momentum and late-stage financing for a thyroid eye disease competitor
Sling Therapeutics raised $123 million in a Series C round led by Forbion to support a Phase III confirmatory study for linsitinib, an oral candidate for thyroid eye disease (TED). The company’s...
Corporate development deal for multiple myeloma trispecific T-cell engager
GSK agreed to acquire global rights to a preclinical trispecific T-cell engager from Chimagen Biosciences in a deal valued at up to $750 million, with Chimagen eligible for success-based...
New regulatory product milestone in radioligand imaging/therapy
Curium received FDA approval for its “radioligand equivalent” to Novartis’s Lutathera, marking the first generic radioligand cleared in the U.S. The decision sets up regulatory and competitive...
Genome engineering innovation with broader targeting and potentially universal therapies
A new paper in Nature describes “prime assembly,” a genome engineering method that enables long DNA fragments to be integrated at precise, programmable genomic positions. The approach uses...
Cell therapy manufacturing automation collaboration
Cellares and GenomeFrontier Therapeutics partnered to evaluate automated manufacturing for GF-CART01 using Cellares’s Cell Shuttle platform. The collaboration focuses on translating...
Immune tolerance startup funding
RegCell closed a $66 million funding round combining a fully subscribed $44 million Series A and a $22 million non-dilutive grant from Japan’s AMED. The company, focused on an immune tolerance...
Preclinical anti-infective innovation using engineered prophylactic phage therapy
Virginia Tech researchers reported prophylactic phage therapy that protects mice against subsequent oral Salmonella infection. The approach engineers a nonpathogenic E. coli “prophage-encoding”...
FDA accelerates early clinical development via expedited IND pilot
The U.S. FDA has launched and begun accepting applications for its Expedited Investigational New Drug (IND) Pilot, designed to shorten the time from drug identification to first-in-human study...
Regulatory scrutiny tightens for overseas clinical data and trial sites
The FDA plans to increase resources for overseas clinical trial site inspections and update risk-based criteria for selecting foreign sites for audit. Acting CDER Director Michael Davis outlined...
Novartis buys blood-brain barrier platform from Sironax
Novartis agreed to pay $125 million for the Sironax blood-brain barrier crossing platform, obtaining global rights to technology intended to transport multiple drug modalities into the central...
Novo and Anthropic expand AI collaboration for drug development workflows
Novo Nordisk announced a collaboration with Anthropic to deploy Claude Science across specific R&D workflows, aiming to speed up drug discovery and development. The companies said they will...
Prime Assembly advances universal genome integration concept
A new Nature study describes “prime assembly,” a genome engineering method designed to integrate long DNA fragments into precise, programmable genomic target sites. The approach extends prime...
Sling lands $123M to push oral thyroid eye disease candidate to Phase 3
Sling Therapeutics raised $123 million in a Series C to support its Phase 3 confirmatory study for linsitinib, an oral treatment targeting thyroid eye disease. The financing was led by Forbion...
GSK commits up to $750M to acquire Chimagen T-cell engager for multiple myeloma
GSK agreed to acquire global rights to a preclinical trispecific T-cell engager from Chimagen Biosciences in a deal worth up to $750 million. The transaction extends GSK’s China innovation...
Sionna Therapeutics cuts workforce after cystic fibrosis trial failure
Sionna Therapeutics announced it is laying off 46% of its workforce after an unexpected cystic fibrosis trial failure. The job cuts come as the company reorganizes its development priorities and...
RegCell raises $66M to take Nobel-winning immune tolerance platform toward clinic
RegCell closed a $66 million funding round to advance its immune tolerance platform built on regulatory T cells, combining a fully subscribed $44 million Series A with a $22 million non-dilutive...
Skyhawk reports extension benefit for Huntington’s RNA-splicing pill and moves toward pivotal studies
Skyhawk Therapeutics reported that its once-daily RNA splicing candidate, SKY-0515, improved clinical symptoms in an extension analysis tied to its early-stage Huntington’s trial program. The...
FDA expedites early-stage drug development
The U.S. FDA launched and began accepting applications for its Expedited Investigational New Drug (IND) pilot, aiming to shorten the timeline for drugs to enter first-in-human studies by removing...