Cardiovascular Outcomes Trials Increasingly Complicated By Missing Data
• By The Pink Sheet
As regulators and payers alike look for sponsors to conduct large-scale cardiovascular outcomes trials in a variety of settings, the problem posed by missing data is a slippery slope, as recent FDA advisory committee reviews of Brilinta and Avandia showcase
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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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MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.