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Pink Sheet Podcast: Novavax Gets EUA, Califf Sets US FDA Departure, Hemophilia Patients Want REMS

Executive Summary

Pink Sheet reporters and editors discuss the FDA’s latest COVID-19 vaccine emergency use authorization, activities during the FDA commissioner’s remaining time in office, and patients requesting a gene therapy risk management plan.

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Pink Sheet Podcast: Trial Diversity, More PTAB Issues, US FDA Controlled Substance Leader Elevated

Pink Sheet reporter and editors discuss another project to improve clinical trial diversity in the US, the Patent Trial and Appeal Board director review process, and the FDA promoting its head of controlled substance policy to deputy CDER director.

Pink Sheet Podcast: New Drug Pricing Bill, Second Amylyx US FDA Adcom, Skipping A Makena Vote

Pink Sheet reporters and editors discuss new changes to the Senate drug pricing bill, the FDA’s decision to call a second advisory committee meeting for Amylyx’s ALS drug, and Covis’ request to skip a vote during the hearing on Makena’s withdrawal.

Citeline And Norstella Merge To Provide End-To-End Solutions For Pharma

Publisher’s Spotlight: Citeline, the publisher of Pink Sheet, is to merge with fellow pharmaceutical solutions provider Norstella.


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