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Keeping Track: First RMAT Approval On The Horizon; Big Weeks For Merck, Lilly And Celgene

 
• By Michael Cipriano, Brenda Sandburg, Bridget Silverman, and Jessica Merrill

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Feature image

As the US Food and Drug Administration and industry cannonballed into June with an explosion of drug development announcements, it was impossible to keep the news brief. So we'll skip the preamble this week and bring you directly to the meat of the action.

It looks like 2019 will be the year the FDA approves the first product with a regenerative medicine advanced therapy (RMAT) designation, as Enzyvant Sciences Ltd. announced on 5 June that its tissue-based product RVT-802 has landed a December priority review user fee goal date

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
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Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

EMA Explores Using AI Language Models To Refine Oncology Guidance

 
• By Vibha Sharma

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Industry On Making England’s HTA Innovation Lab A Success

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.