News

BioSpace6h
July Layoffs Skyrocket 487% YOY With Merck Cuts
The number of biopharma professionals let go has increased year over year for three straight months. In July, nearly 8,000 ...
Rheumatology Advisor7h
Elevidys Use for Ambulatory DMD Patients May Resume, Says FDA
The FDA is allowing Sarepta to resume shipments of Elevidys (delandistrogene moxeparvovec) to ambulatory patients with Duchenne muscular dystrophy.
BioSpace16h
Cracking the Commercial Code for Cell and Gene Therapies
From innovation in manufacturing to more-flexible regulation and better communication with payers, much needs to happen to ...
FDA Chief Says He Wants Gene Therapy Head Prasad to Return
US Food and Drug Administration Commissioner Marty Makary said he’s trying to persuade Vinay Prasad, the agency’s former head ...
BioPharma Dive1d
The race to scale to 1,000 liters and beyond in gene therapy manufacturing
Extend transfection complex formation time by up to 3 hours, reduce complex volume by >50% and maintain high titers and full ...
GEN - Genetic Engineering and Biotechnology News2d
StockWatch: As Prasad Exits FDA, Analysts See Benefit for Sarepta, CGT Stocks
Rare disease and gene therapy stocks, battered in recent months by clinical and commercial setbacks, will likely benefit from ...
FDA’s Reversal on Gene Therapy Helps My Son
Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.
Fierce Pharma4d
Untangling Sarepta’s gene therapy fallout and a growing trust deficit
Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...
FDA vaccine chief steps down after controversial tenure
The U.S. Food and Drug Administration's (FDA) top vaccine official is stepping down after just three months in a role that ...
The American Journal of Managed Care5d
FDA Recommends Sarepta Resume DMD Gene Therapy Shipments for Ambulatory Patients
Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...
Fierce Pharma5d
Vinay Prasad's exit signals FDA's probable slip toward more permissive regulation of cell and gene therapy: analyst
But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
Andover Townsman5d
493 employees laid off at biopharmaceutical company with operations in Andover
A biopharmaceutical research company with ties in Andover has laid off a third of its workforce as one of the leaders in gene therapy goes through a “strategic ...