FDA
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
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The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in dealings with the agency, while insiders warn of falling morale and a negative perception from the rest of the biopharma world.
Executives from Eli Lilly, Merck and other companies foresee the FDA’s new onshoring proposal being anything from a bureaucratic waste of time to a transformative program that will eliminate inspection-related complete response letters.
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The FDA awards a second round of Commissioner’s National Priority vouchers to six larger biopharma companies. And this time, with the exception of Eli Lilly’s orforglipron, the vouchers are for drugs that are already on the market.
The search continues for a new leader for the FDA’s Center for Drug Evaluation and Research after George Tidmarsh resigned on Sunday. Deputy Director Mike Davis is in the running, along with Mary Thanh Hai, currently head of the Office of New Drugs.
The FDA is undergoing a major transformation in its drug approval processes, regulatory oversight and transparency initiatives. This webinar explores the implications of these reforms and what they mean for innovation, compliance and strategy in the biopharma industry.
Kygevvi is indicated for patients with thymidine kinase 2 deficiency whose symptoms arise by 12 years of age. The disease manifests as muscle weakness and can become life-threatening in severe instances.
Less than 24 hours after resigning his post as the FDA’s head drug regulator, George Tidmarsh is reportedly reconsidering his decision and vowing to fight for his name and credibility amid a probe into his “personal conduct” at the agency.
A month after sparking optimism for patients with Huntington’s disease with highly positive data for AMT-130, uniQure revealed Monday that the FDA may be changing its tune on the evidence required for an approval application, a change of direction Stifel called “very challenging” for uniQure.
Vinay Prasad, chief of the FDA’s Center for Biologics Evaluation and Research, is planning to publish a paper this month to outline his office’s thinking on accelerating gene editing reviews.
The clinical hold comes days after Intellia voluntarily paused enrollment and dosing in the same two studies.
Generic versions of biologic drugs could hit the market without human trials and allow the market forces to bring down costs, HHS leaders said while announcing new draft guidance.
Despite the rejection, analysts saw Regeneron’s use of an alternate filler for Eylea HD as a positive development, with BMO Capital Markets noting that this could signal the end of manufacturing troubles for the franchise.