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Trump’s ‘Warp Speed’ Initiative Could Fund 3 to 5 Large-Scale COVID Vaccine Trials

 
• By Brenda Sandburg

FDA’s Peter Marks and Janet Woodcock will be on the bridge for Operation Warp Speed; Moncef Slaoui says early clinical data on one vaccine candidate makes him confident that a few hundred million doses of a vaccine can be available by the end of the year.

Moncef Slaoui at White House press briefing
Former GSK vaccine chief Moncef Slaoui speaks at White House press briefing on 15 May 2020. NIAID's Anthony Fauci stands behind him wearing a mask. • Source: White House TV feed

President Trump has tapped two of the top officials in the US Food and Drug Administration – Peter Marks, director of the Center for Biologics Evaluation and Research, and Janet Woodcock, director of the Center for Drug Evaluation and Research – to take leading roles in his Operation Warp Speed initiative.

The program is intended to facilitate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics between the Department of Health and Human Services, the Department of Defense, private firms and other federal agencies

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Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

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US FDA Vaccine Framework Coming In Weeks, But Details Vague

 
• By Sarah Karlin-Smith

New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.

More from Pink Sheet

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

Biomarker Negativity At Issue In Pfizer Bid To Broaden Talzenna CRPC Claim

 
• By Bridget Silverman

The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.