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The UK’s drug pricing watchdog has recommended reimbursement of Novartis’ innovative drug Cosentyx for ankylosing spondylitis, but only if it provides it at a discount. Read More
In the absence of industry pushback, an FDA final rule on manufacturing procedures and dating processes for biologics will take effect as planned on Sept. 16. Read More
The FDA wants drugmakers to use clinical remission as their primary endpoint when conducting trials for short-term ulcerative colitis therapies. Read More
Industry continues to be divided on whether to include interchangeability statements on biosimilar labels, with Amgen taking the lead in support and Merck taking the lead against in comments on the FDA’s March draft biosimilar labeling guidance. Read More
Two FDA advisory committees recommend the approval of Egalet's opioid Arymo to manage severe pain that requires daily, long-term treatment when alternatives are unavailable, with three abuse-deterrent labels. Read More
An FDA advisory committee recommended FDA approve Amgen’s biosimilar of the AbbVie’s blockbuster drug Humira and Sandoz’s biosimilar of Amgen’s Enbrel. Read More
Mylan has agreed to shed two generics that treat muscle pain and epilepsy to allay FTC antitrust concerns, clearing the way for its $7.2 billion acquisition of Meda. Read More
The FDA approved eight ANDAs for AstraZeneca’s blockbuster cholesterol drug Crestor after a federal judge denied the company’s bid to stave off the approvals. Read More