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The FDA could be increasing its recommendation on the amount of proposed suffixes — from three to 10 — that biosimilars applicants can propose for their products. Read More
BioMarin is calling it quits for its Duchenne muscular dystrophy candidate and three related products in its pipeline after the EMA’s Committee for Medicinal Products for Human Use signaled that it would not back the candidate. Read More
A Janssen production plant that turned heads for its continuous production line was handed a 483 two months prior to switching the line from batch production. Read More
The UK’s National Institute for Health and Care Excellence refused to recommend Janssen’s chronic lymphocytic leukemia treatment Imbruvica for reimbursement on Wednesday, but left the door open to further discussion. Read More
Drugmakers submitting ANDAs for products using transdermal delivery systems are expected to demonstrate that they made “reasonable efforts” to optimize the adhesive characteristics of their patches, the FDA says. Read More
A Merck unit will lose four of its five patents on its skin infection therapy Cubicin after the U.S. Supreme Court denied the drugmaker’s appeal Tuesday. Read More