News

BioSpace1d
After Prasad’s Ouster, Makary Looks for Better Drug, Biologic Alignment at FDA
The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation ...
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 Pharma1d
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 ...
European Medical Journal1d
FDA and NICE: Two leaders step down in same week
Two major health agencies are facing leadership reshuffles, with the resignations of the FDA’s Vinay Prasad and NICE’s Dr Sam Roberts.
PTC Therapeutics: Uncertainty Abounds Ahead Of Q2 Earnings - I'm Upgrading To 'Hold'
PTC Therapeutics faces pivotal FDA decisions for approvals that could potentially transform their long-term revenues. Click ...
The American Journal of Managed Care2d
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 Pharma2d
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 Townsman2d
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 ...
Public Broadcasting Service (PBS)3d
Controversial FDA vaccine chief departs agency after less than 3 months
Dr. Vinay Prasad is stepping down as the Food and Drug Administration’s top vaccine regulator after a brief tenure. A ...
Amazon S3 on MSN3d
The story of Sarepta's Duchenne gene therapy
The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...
STAT3d
STAT breaks down the confusing, heartbreaking Sarepta saga
In the latest episode of STATus Report, Alex Hogan breaks down the confusing, heartbreaking saga of Sarepta and its gene ...