A New Jersey federal court threw out Johnson & Johnson’s patent on a top-selling prostate cancer treatment. Source: Drug Industry Daily

The FDA cited New Taipei City manufacturer Delta Synthetic for its methods of sanitizing the facility’s water system. Source: Drug Industry Daily

A Delaware court on Monday sided with Fresenius in its bid to pull out of a planned $4.3 billion merger with Akorn because of alleged fraud and falsified testing data…

Brand name prescription drug prices increased four times faster than inflation last year, according to AARP’s latest drug pricing report. Source: Drug Industry Daily

A provision in the proposed U.S.-Mexico-Canada Agreement that would give branded biologics makers a decade of exclusivity goes against the White House’s stated priority of improving access to biosimilars, according…

The FDA placed valsartan manufacturer Zhejiang Huahai on an import alert Friday and the EMA issued a noncompliance statement barring Europe’s drugmakers from using the company’s API in their blood…

Several leading drugmakers — including Janssen, Novo Nordisk and Genentech — urged the FDA to include new information on interchangeable products in the agency’s Purple Book, which lists biological products…

In new draft guidance issued Friday, the FDA outlined what it expects sponsors to include in submissions of use-related risk analyses, threshold analyses, comparative use human factors (HF) and HF…

The FDA Friday issued two new draft guidances — one on adaptive clinical trials and the other on master protocol designs — that it hopes will help sponsors innovate and…

A newly unsealed lawsuit accuses AstraZeneca of using nurses to covertly promote its products, echoing a similar complaint against AbbVie. Source: Drug Industry Daily