CERTs Risk Management Agenda Includes Tikosyn Study, Workshops
The initial results from a CERT study of the risk management program for Pfizer's anti-arrhythmia drug Tikosyn (dofetilide) may indicate some practical limits to well-designed monitoring plans, Office of Postmarketing Drug Risk Assessment Director Peter Honig, MD, suggested Nov. 5
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.