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Latest From Brenda Sandburg
Former Pfizer employee has joined Sun Pharma as it launches ophthalmic drug and expands its specialty portfolio, which includes Phase III monoclonal antibody for treatment of psoriasis.
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.