All articles tagged with #peter marks
An opinion piece argues that FDA leaders Peter Marks and Vinay Prasad have pursued a rigorous, aggressive regulatory approach that comes with costs for biotech firms and patients, fueling debate over approving drugs with uncertain benefits.
Peter Marks, the former FDA vaccine regulator, has joined Eli Lilly to lead molecule discovery and infectious diseases, sparking criticism over the revolving door between regulatory agencies and the pharmaceutical industry.
Peter Marks, the FDA's chief of vaccines and biologics, announced at the Jefferies London Healthcare Conference that he intends to remain in his position as long as he is welcome, despite any incoming changes.
Peter Marks, a top FDA official, publicly defended the safety and efficacy of vaccines amid concerns that President-elect Donald Trump might appoint vaccine skeptic Robert F. Kennedy Jr. to influence health policies. Speaking at a health summit, Marks emphasized the robust evidence supporting vaccines and the potential negative impact of revisiting their safety on the FDA's ability to approve new treatments. He highlighted the dedication of FDA employees to public health and expressed willingness to engage in dialogue with Kennedy, while maintaining the importance of keeping an open mind about vaccine benefits.
Peter Marks, the FDA's top gene therapy regulator, appears open to granting some form of full approval to Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy, Elevidys, despite the failure of a confirmatory study in October. Marks suggested that the FDA has approved products based on aggregate scale performance, indicating a potential willingness to overlook certain imperfections in the data.
Peter Marks, the senior FDA official overseeing gene therapies, overrode agency reviewers' decision to reject Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy after disagreeing with parts of their interpretation of the limited efficacy data. The FDA granted accelerated approval to Sarepta's gene therapy, marketed as Elevidys, in boys aged 4 and 5 years old.
FDA staff were leaning towards rejecting Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy, but a top official, Peter Marks, intervened and directed staff to schedule a public hearing on the therapy. Marks is a vocal advocate for faster gene therapy approvals.