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Amgen is suing the FDA, requesting that its Sensipar medication be granted six additional months of pediatric market exclusivity after it completed three of four pediatric clinical trials requested by the agency. Read More
Merck and Optum, a division of UnitedHealth Group, have launched a multi-year collaboration exploring value-based payment models for pharmaceuticals. Read More
With federal action on drug prices and cost transparency stalled in Congress, three states have pushed through their own legislation, with one bill becoming law and another awaiting a governor’s signature. Read More
The U.S. Supreme Court ruled that patent infringement lawsuits may only be filed where defendant companies are incorporated, and not simply in any location where their products are sold — a decision with serious implications for drugmakers. Read More
Janssen has filed suit in a New Jersey federal court, hoping to delay a recently approved Remicade biosimilar from entering the market — while the biosimilar’s developer, Samsung Bioepis, bets on an upcoming U.S. Supreme Court decision going its way. Read More
The PTO’s Patent Trial and Appeal Board invalidated a patent for AbbVie’s flagship drug Humira, saying its claims were unpatentable following a challenge by Coherus Biosciences. Read More