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Can GSK Veteran Moncef Slaoui Get COVID-19 Vaccine Development To Warp Speed?

 
• By Brenda Sandburg

President Trump's Operation Warp Speed initiative aims to have a COVID-19 vaccine available by the end of the year; Slaoui, who helped get the first cervical cancer vaccine to market and win European approval of the first malaria vaccine while at GlaxoSmithKline, is tasked with coordinating the government's contributions to coronavirus vaccine effort and achieving what would be twin scientific and manufacturing miracles. 

Covid_2019_Vaccine
Former GSK vaccine head to lead Warp Speed initiative for COVID-19 vaccine

Moncef Slaoui, former chairman of global vaccines at GlaxoSmithKline PLC, has been given the task of leading President Trump's Operation Warp Speed initiative, with the goal of producing a COVID-19 vaccine by the end of the year.

He is credited with overseeing the development of several vaccines during his 29-year career at GSK, including the cervical cancer...

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• By Sarah Karlin-Smith

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Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 
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Danish Medicines Agency Wants Companies To Use “Better Data Format” To Submit Bioequivalence Studies

 
• By Anabel Costa-Ferreira

The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.

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Sam Roberts, chief executive of the health technology assessment institute, NICE, will step down from her role at the end of the year. The agency is now on the lookout for a new leader, who will be the fourth in its history.

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• By Nielsen Hobbs and Derrick Gingery

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.