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Latest From Brenda Sandburg
Agency declined to say whether ANDA sponsors would need to meet requirements requested by Sandoz; Mylan's generic user fee date is March 28.
Innovators say case before court could upend ANDA litigation by preventing consolidation of cases; Genentech sees potential impact on biosimilar suits.
First new chemical entity for Parkinson's to clear FDA in 10 years, Xadago has a narrower indication than Teva's Azilect and similar pricing.
After overcoming regulatory hurdles, Newron may have tough time competing in US against market stalwart Azilect; eight Parkinson's drugs are in Phase III trials.
Tribunal finds Lilly did not prove that Canada's promise utility doctrine discriminates against pharmaceutical patents; 25 pharma patents have been invalidated in past decade.
Transparency reports from companies aim to change conversation from prices to discounts, but also invite comparisons. Lilly, for example, saw a higher average list price increase in 2016 than Merck and Janssen, but its net prices grew by less than the others.