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Merck and Upsher-Smith Laboratories agreed to pay $60.2 million to settle a 17-year-long class action suit over plans to delay a generic potassium deficiency treatment — a case that survived three rounds of mediation, over four years of discovery, and a trip to the Supreme Court. Read More
Celltrion has filed two petitions against a Genentech patent with the PTO, requesting an inter partes review of a method for making antibodies related to Herceptin. Read More
More drugmakers have weighed in on the FDA’s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy. Read More
Amgen is suing Coherus Biosciences over its processes for manufacturing a biosimilar of Neulasta, saying it infringes patented methods for purifying proteins. Read More
Maryland’s governor allowed a ban on generic drug price gouging to become law without his signature, in part due to reservations over its constitutionality. 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 Supreme Court decision going its way. Read More
Scott Gottlieb was sworn in as the 23rd FDA commissioner May 11, with plans to face the nationwide opioid crisis, which he has called the agency’s number one challenge, and outlined his vision for a more risk-based, patient-centric organization. Read More
The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure Monday, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers. Read More
House and Senate panels proceeded with advancing the FDA user fee reauthorization package last month, even while Trump and HHS called for negotiations on the amounts paid by industry to be reopened — and nearly doubled. Read More