High-level FDA inspection official to retire | US orders freeze-dried mpox vaccine doses | Gilead boosts US investment by $11B to $32B
May 9, 2025
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The FDA plans to deploy AI tools across all agency centers by June 30, following a pilot program for scientific reviewers. The move is intended to streamline the drug application review process by automating repetitive tasks.
Full Story: Wired (tiered subscription model) (5/7),  Regulatory Focus (5/8),  Reuters (5/8) 
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Legislative & Regulatory News
Michael Rogers, the FDA's associate commissioner for inspections and investigations, announced his retirement effective May 14, after 34 years with the agency. Rogers' departure comes amid recent challenges, including staff cuts and a reorganization of the inspection office.
Full Story: CBS News (5/5) 
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The US government has ordered $144 million worth of a freeze-dried version of Bavarian Nordic's Jynneos vaccine for mpox and smallpox. The freeze-dried formulation is easier to transport and store than the liquid-frozen version.
Full Story: Center for Infectious Disease Research and Policy (5/6) 
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Drug Industry Spotlight
Gilead Sciences is increasing its US investment by $11 billion, bringing the total to $32 billion by 2030, amid expected tariffs specific to the pharmaceutical sector. The investment will fund new facilities, upgrades to existing sites, and enhancements in R&D and manufacturing capabilities.
Full Story: PharmaPhorum (UK) (5/8) 
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AstraZeneca opens cell therapy manufacturing site in Md.
(Jonathan Nackstrand/Getty Images)
AstraZeneca has opened its new $300 million cell therapy manufacturing facility in Rockville, Md., creating at least 150 jobs. The facility is set to produce clinical and potential commercial CAR-T treatments and forms a crucial part of AstraZeneca's $3.5 billion investment strategy in the US.
Full Story: Fierce Pharma (5/6),  Fox Business (5/6) 
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