Get the Daily Brief
Latest Biotech News
Duchenne cell therapy faces FDA advisory blowback
Capricor’s deramiocel was voted down by the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee, with the panel concluding the available evidence for cardiomyopathy benefit in Duchenne...
Groundbreaking Phase 3 outcome for deramiocel
A Phase 3 trial published in The Lancet reports that deramiocel, a donor-derived heart-derived cell therapy, slowed muscle decline in boys and young men with advanced Duchenne muscular dystrophy...
J&J doubles down on in vivo CAR-T with Sail option
Johnson & Johnson agreed to pay $785 million upfront to secure an option to acquire Sail Biomedicines, signaling renewed Big Pharma interest in in vivo CAR-T approaches for autoimmune disease....
GSK expands AI-driven target discovery collaboration with Relation
GSK and Relation Therapeutics expanded their AI pact, with GSK set to pay Relation up to $110 million to scale the discovery of therapeutic targets using multi-omic perturbation datasets. The...
Insilico wins FDA fast track for AI-designed mesothelioma inhibitor
The FDA granted Fast Track designation to Insilico Medicine’s ISM6331, an investigational pan-TEAD inhibitor being developed for adult patients with unresectable malignant pleural mesothelioma...
Alnylam cuts Amvuttra guidance amid shifting demand
Alnylam reduced its Amvuttra sales guidance after reporting demand shifts that continued to weigh on the company’s outlook. The update came with its second-quarter earnings, which did little to...
GSK prepares for patent cliff with multibillion cost-cutting plan
GSK unveiled a three-year cost-cutting program intended to save about £1.9 billion (roughly $2.5 billion) per year as the company braces for a major patent cliff affecting parts of its HIV...
Next-gen cell therapy funding pipeline: IPO runway for Apnimed
Apnimed filed for an IPO targeting the obstructive sleep apnea market, seeking to raise up to $160 million as it advances its oral therapy Oxnimbi (AD109) toward commercialization. The company...
Revenue and strategy reset: Biogen eases M&A while eyeing late-stage readouts
Biogen CEO Christopher Viehbacher told analysts the company will slow the pace of M&A for now, pointing to portfolio breadth built through recent acquisitions and deal activity. On an earnings...
Commercial infrastructure boost: Celonic and Leukocare team on complex biologics
Celonic and Leukocare announced a collaboration to support development and manufacturing of complex biologics, pairing Celonic’s CHO process and GMP capabilities with Leukocare’s data...
FDA advisory committee turns against Capricor’s deramiocel for Duchenne cardiomyopathy
The U.S. FDA Cellular, Tissue, and Gene Therapies Advisory Committee voted against Capricor Therapeutics’ allogeneic cell therapy deramiocel for Duchenne muscular dystrophy-related cardiomyopathy...
Phase 3 deramiocel data in The Lancet show slower muscle decline in advanced DMD
Deramiocel, a heart-derived cellular therapy, showed a slowing of muscle weakening in boys and young men with advanced Duchenne muscular dystrophy in a Phase 3 trial published in The Lancet. The...
FDA expert panel review pressures Replimune’s RP1 melanoma program
The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee convened to review Replimune’s RP1, an engineered viral immunotherapy for melanoma, in a meeting tied to a possible path for...
J&J’s Sail Biomedicines deal pushes deeper into in vivo CAR-T with option to acquire
Johnson & Johnson expanded its in vivo CAR-T strategy by paying $785 million upfront to work with Flagship Pioneering’s Sail Biomedicines and to obtain an option to acquire the company. The move...
Vertex backs AbCellera’s multispecific T-cell engager platform in autoimmune push
AbCellera and Vertex Pharmaceuticals struck a collaboration to discover and develop multispecific T-cell engagers for autoimmune diseases and other conditions. Vertex will fund R&D, with AbCellera...
New Phase 2 readout targets non-opioid post-surgical pain with LTG-001
Latigo Biotherapeutics reported Phase 2 evidence for LTG-001, an oral therapy being evaluated as a non-opioid option after surgery. In the trial of 343 patients undergoing tummy tuck...
Alveo and UTMB advance point-of-care Lassa testing for field settings
Alveo Technologies partnered with the University of Texas Medical Branch (UTMB) to develop and evaluate a molecular point-of-care diagnostic for Lassa fever. The collaboration targets limited...
Claris raises $118M Series B to push limbal stem cell deficiency eye drop into pivotal trials
Claris Biotherapeutics closed an $118 million Series B and set course for pivotal testing of CSB-001, an ophthalmic solution for limbal stem cell deficiency. The funding supports two pivotal...
DNA script distribution expansion brings on-demand DNA synthesis to India
DNA Script expanded access to its SYNTAX® enzymatic DNA synthesis platform in India through a distribution agreement with Imperial Life Sciences. The deal is designed to support decentralized,...
Sanofi exits and write-off targets immunology pipeline after eczema asset termination
Sanofi reported over €1.03 billion in impairment charges tied largely to the termination of an eczema drug program, and said its pipeline review resulted in wind-downs of two additional immunology...