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Lunge cancer immunotherapy readout strengthens ivonescimab competitive position
Akeso and Summit Therapeutics disclosed further Phase 3 data for ivonescimab (HARMONi-2), reporting an overall survival benefit versus Merck’s Keytruda (pembrolizumab) in lung cancer. In the...
Novartis buys blood-brain barrier platform from Sironax to advance brain delivery
Novartis agreed to pay $125 million for Sironax’s blood-brain barrier crossing technology, giving the Swiss drugmaker a platform designed to transport a range of drug modalities into the central...
Stem cell therapy setback triggers Longeveron ‘review all options’ response
Longeveron said its Phase 2b stem cell program in pediatric heart disease missed its primary endpoint, prompting the cash-strapped biotech to pursue cost-cutting and “review all options” for the...
Designing universal gene therapies with prime assembly improves targeted DNA integration
A new Nature paper describes “prime assembly,” a genome engineering approach that enables targeted integration of long DNA fragments at programmable sites. Unlike earlier editing approaches that...
Funding and platform scaling for cell therapy manufacturing automation in Asia and the US
Cellares and GenomeFrontier Therapeutics launched a collaboration to evaluate automated manufacturing for GF-CART01 using Cellares’ Cell Shuttle platform. The partnership focuses on translating...
Investor-backed oral thyroid eye disease challenger secures $123M to reach Phase 3 finish
Sling Therapeutics closed a $123 million Series C financing to support its Phase 3 confirmatory trial for oral thyroid eye disease (TED) candidate linsitinib (Orbit). The randomized study compares...
Biosecurity and oversight pressures as AI expands biotech capabilities and risks
A House hearing highlighted rising biosecurity concerns tied to accelerating AI capabilities in biotechnology. Rep. Rick McCormick, R-Ga., said AI is lowering barriers to biological misuse by...
Neurodegeneration biotech: Huntington’s RNA-splicing pill posts extension improvement
Skyhawk Therapeutics reported symptom improvements in an extension update for its Huntington’s disease candidate SKY-0515, an oral “RNA splicing” therapy designed to address mutant huntingtin...
Genomic immune tolerance startup RegCell raises $66M with AMED grant support
RegCell secured $66 million to advance its immune tolerance platform into clinic development. The funding combines a fully subscribed $44 million Series A and a $22 million non-dilutive grant from...
Regulatory acceleration: FDA Expedited IND Pilot
The FDA has launched and is accepting applications for an Expedited Investigational New Drug (IND) Pilot aimed at speeding the path to first-in-human studies. The pilot is designed to reduce...
FDA tightens oversight of foreign clinical trial data
The FDA said it will boost resources for overseas clinical trial facility inspections and update risk-based criteria for selecting foreign sites for audit. Acting CDER director Michael Davis laid...
Corporate deal: Novartis buys blood-brain barrier delivery platform from Sironax
Novartis agreed to pay $125 million to acquire a Sironax blood-brain barrier (BBB) crossing technology, securing a platform intended to move multiple modalities into the CNS. The deal hands...
Clinical readout and pipeline milestone: Skyhawk’s RNA-splicing Huntington’s drug
Skyhawk Therapeutics reported extension results for its Huntington’s disease candidate, SKY-0515, describing symptom improvements after 15 months and a continued lowering of mutant huntingtin. On...
Cell therapy manufacturing: Cellares and GenomeFrontier scale automated GF-CART01 production
Cellares and GenomeFrontier Therapeutics entered a partnership to evaluate automated manufacturing for GF-CART01 using Cellares’ Cell Shuttle platform. The collaboration focuses on translating...
Regulatory and pipeline strategy: GSK expands China oncology with a new T-cell engager
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 follows GSK’s prior Chimagen licensing...
Oncology diagnostics: FDA clears first glioma FET-PET radiopharmaceutical
The FDA approved Telix Pharmaceuticals’ Pixclara (floretyrosine F-18, 18F-FET), marking the first FDA-approved FET-PET imaging agent for glioma and the first US-cleared PET radiopharmaceutical...
Therapeutics and biosecurity debate: AI-enabled biological risk raises alarms in Congress
A US House Space, Science and Technology subcommittee hearing renewed scrutiny of how AI is accelerating biotech while also raising biosecurity risks. Rep. Rick McCormick (R-Ga.) opened the...
Genomic engineering: prime assembly enables precise integration of long DNA fragments
Researchers published a Nature study describing prime assembly, a genome-engineering method that supports targeted integration of long DNA fragments into programmable positions in living cells....
Funding: RegCell advances immune tolerance platform with $66M round
RegCell raised $66 million to advance its regulatory T-cell (Treg) immune tolerance platform toward the clinic. The round combines a fully subscribed $44 million Series A financing with a $22...
Regulatory oversight and clinical trial access
The FDA is increasing scrutiny of overseas clinical trial sites, expanding resources for foreign bioresearch monitoring (BIMO) inspections and revising how it selects foreign locations for audit....