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The Pharma Letter41m
Industry anger at FDA oustings
The Alliance for Regeneration Medicine (ARM), a trade group that represents more than 400 members companies across 25 ...
GEN - Genetic Engineering and Biotechnology News1d
StockWatch: CGT Stocks Fall on FDA Therapeutic Products Upheaval
Nicole Verdun, MD, super office director of the FDA’s Office of Therapeutic Products (OTP) and her deputy Rachael Anatol, PhD ...
Health Care Down on FDA Concerns -- Health Care Roundup
The departure of Food and Drug Administration official Dr. Nicole Verdun, who was in charge of regulating gene therapies and cell therapies, is setting off a new round of worries for biotech investors ...
BioWorld2d
NICE rejects Alzheimer’s drugs Kisunla and Leqembi
To no great surprise, the U.K.’s health technology assessment body has found that the benefits of the first two approved Alzheimer’s disease drugs are too small to justify the costs. Neither Kisunla ...
STAT2d
Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official
The ouster of the FDA's chief regulator of cell and gene therapies came immediately after a disagreement with her boss over a ...
Gene Therapy Stocks Fall as FDA Pushes Out Another Top Regulator
The HHS said center directors deserve to be supported by managers aligned with aggressive goals “to expeditiously advance ...
Stocktwits on MSN3d
Capricor Stock Slumps 16% On Report Of Key FDA Executive’s Removal, But Retail’s Hopeful About New 4-Year Deramiocel Data
Shares of Capricor Therapeutics (CAPR) tumbled 16% on Friday morning following reports that Nicole Verdun, director of the ...
Capricor Therapeutics stock plunges after key FDA officials placed on leave
This leadership vacuum follows another significant departure at the FDA. Peter Marks, former head of the Center for Biologics Evaluation and Research who worked closely with Verdun on establishing new ...
BioPharma Dive3d
Gene therapy faces fresh uncertainty as two more top FDA officials depart
The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about how gene therapies will be regulated under new FDA leadership.
FDA cell and gene therapy director exit increases ‘volatility’ for sector
Nicole Verdun, a highly respected individual in the cell and gene therapy space, was placed on administrative leave this week ...
Fierce Biotech3d
Industry deeply disappointed as FDA reportedly puts cell and gene therapy chief on leave
The Alliance for Regenerative Medicine has voiced deep disappointment about reports that the FDA has put the director of its ...
STAT4d
Top gene therapy regulator forced out at FDA
Nicole Verdun, director of the office that reviews cell and gene therapies at the Food and Drug Administration, and her ...