FDA's Victoza Decision BalancedUnknown Cancer Risk Against Known FDAAA Measures
FDA’s approval of Novo Nordisk’s type 2 diabetes drug Victoza (liraglutide) was a bit surprising for an agency often seen as increasingly conservative, even given that the Jan. 25 decision came with extensive labeling, risk management and mandatory post-market studies focused on the cancer risk.
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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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The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.
Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.