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The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended 11 medicines for approval, including one new cell therapy, four new drugs and four biosimilars. 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
Newly minted FDA Commissioner Scott Gottlieb comes into office immediately faced with many challenges: from hiring issues to budget concerns, drug prices and a nationwide opioid addiction crisis. But those who have worked with him say he’s the ideal man for the job. Read More