Astellas Pharma filed suit against generics makers Roxane Laboratories, West-Ward Pharmaceuticals and Hikma Pharmaceuticals over their copycat version of Xtandi. Source: Drug Industry Daily

The China Food and Drug Administration is taking public comments on four proposed reforms, covering the review of new drug applications, the deregulation of clinical trials, postmarket surveillance and intellectual…

The European Commission has opened a formal antitrust investigation into South African manufacturer Aspen Pharma over concerns of excessive pricing of five cancer medicines. Source: Drug Industry Daily

A bipartisan trio of senators urged the Office of Management and Budget to take administrative action to lower prescription costs — while 36 House Democrats asked President Trump to consider…

The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure Monday, aligning inspection staff into seven product categories — more closely mirroring the organization of the…