An FDA investigation into serous quality problems at a Florida pharmaceutical company revealed a litany of unsound practices in the manufacture of experimental drugs. Source: Drug Industry Daily
The FDA’s new commissioner, Scott Gottlieb, addressed the agency’s full staff for the first time May 15 and highlighted the agency’s key role in combating the opioid crisis. Source: Drug…
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…
The FDA hit an Ohio outsourcing facility with an extensive Form 483, listing failures to adhere to GMP and overall sterility, cleaning and quality control issues—with several problems repeated from…
Celltrion has filed two petitions against a Genentech patent with the PTO, requesting an inter partes review of a method for making antibodies related to Herceptin. Source: Drug Industry Daily
Amgen is suing Coherus Biosciences over its processes for manufacturing a biosimilar of Neulasta, saying it infringes patented methods for purifying proteins. Source: Drug Industry Daily