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Eli Lilly & Co. settled with several generic companies to resolve pending litigation over a unit dose patent for Cialis (tadalafil), delaying potential ANDA competition. Read More
The PTO’s Patent Trial and Appeal Board once again ruled that a patent for AbbVie’s Humira was invalid and unpatentable, responding to additional challenges by Boehringer Ingelheim. Read More
A Pennsylvania federal court ruled that 11 generic manufacturers, including several subsidiaries of Teva Pharmaceuticals, must answer to a class-action lawsuit claiming they violated state consumer protection and unfair trade practice laws by inflating their prices. Read More
The PTO’s Patent Trial and Appeal Board rejected five Mylan challenges to patents held by UCB Pharma and Pfizer covering the overactive bladder treatment Toviaz. Read More
Following the U.S. Supreme Court’s defining decision on the biosimilar “patent dance” and approval process, Sandoz has requested that an unresolved part of its case against Amgen return to a California federal district court. Read More
The FDA is planning to modernize its recruitment and hiring practices to fill the several hundred vacancies plaguing the agency and attract more scientific talent. Read More
The Association for Accessible Medicines filed a lawsuit against the attorney general of Maryland, hoping to block the state’s recently passed law ostensibly banning generic drug price gouging. Read More