Boehringer and AnGes sign manufacturing agreement for HGF gene therapy product

Collaboration reinforces Boehringer Ingelheim’s expertise in microbial contract development and manufacturing

FDA grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy

KER-065 is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB

Piramal Pharma Solutions opens dedicated OSD production capabilities at Sellersville, Pennsylvania site

The suite represents a multi-million-dollar investment in equipment upgrades and enhancements to improve the site's capabilities

Sarepta advances siRNA collaboration and sale of arrowhead equity investment

Sarepta has also entered into an agreement with Arrowhead to transfer 2,660,989 shares of Arrowhead common stock in satisfaction of $50 million of the company’s previously announced $100 million milestone payment obligation

AAVantgarde Bio receives FDA fast track designation for AAVB-039 in stargardt disease

The therapy delivers the full-length ABCA4 protein and has the potential to benefit all patients with ABCA4 mutations

Sigachi begins construction work for MCC capacity expansion at Dahej

With this addition, the company’s total Installed MCC Capacity will rise to 30,000 MTPA

Vertex faces regulatory delays for Journavx and reports VX-993 Phase 2 trial failure

Treatment with the selective NaV1.8 pain signal inhibitor VX-993 after bunionectomy surgery did not meet the primary endpoint

Sanofi’s GPRC5D monoclonal antibody earns ODD in US for multiple myeloma

Bristol Myers Squibb and Bain Capital launch biotech company NewCo

NewCo’s pipeline includes five investigational medicines

Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys

FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths