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Amazon S3 on MSN23h
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 ...
Fierce Pharma5h
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 ...
Who is Vinay Prasad? US FDA's top regulator exits agency after controversy over Sarepta gene therapy
Dr Vinay Prasad has resigned from the FDA after less than three months amid controversy over Sarepta Therapeutics' gene ...
TipRanks on MSN20h
Sarepta Stock (SRPT) Rallies on FDA Nod for Broader Gene Therapy Use
Shares of Sarepta Therapeutics ($SRPT) jumped over 14% on Tuesday after the FDA authorized the company to restart shipments ...
Gene Therapy Market Fueled By CRISPR Advances & Regulatory Momentum Datam Intelligence
Gene Therapy Market Gene therapy market surges on breakthroughs in genome editing, rising chronic & genetic disease cases, regulatory appro ...
Why Vinay Prasad Had to Go at FDA
The gene therapy chief wanted to block fast-track drug approvals.
GlobalData on MSN1d
Prasad’s FDA exit may accelerate cell and gene therapy approvals
Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), has stepped down, with market analysts forecasting a boost to the cell and ...
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 ...
George Tidmarsh to sub in as FDA CBER head following Prasad’s shock exit
Tidmarsh will temporarily guide CBER’s regulatory activities while the FDA searches for a permanent department lead.
STAT4h
Moderna announces layoffs, and Alnylam’s heart drug sees quick uptake
Alnylam Pharma raised its revenue outlook as its heart drug sees quick uptake.
India Today13h
Top US vaccine official Vinay Prasad leaves agency 3 months after being appointed
Other changes under Prasad, who was also the agency's chief medical and science officer, included a new policy limiting the ...
Andover Townsman9h
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 ...