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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
The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers. Read More
An FDA investigation into serous quality problems at a Florida pharmaceutical company revealed a litany of unsound practices in the manufacture of experimental drugs. 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
HHS has once again pushed back the effective date of its final rule instituting fines for drugmakers that overcharge for products under the 340B drug discount program. Read More