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The FDA has issued a boxed warning for Johnson & Johnson’s Invokana (canagliflozin) treatment for type 2 diabetes, describing a doubled risk of leg and foot amputations compared to placebo. In 2016, Invokana brought in more than $1.4 billion in sales. 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 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. Read More
Astellas Pharma filed suit against generics makers Roxane Laboratories, West-Ward Pharmaceuticals and Hikma Pharmaceuticals over their copycat version of Xtandi. Read More
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 property rights. Read More
The European Commission has opened a formal antitrust investigation into South African manufacturer Aspen Pharma over concerns of excessive pricing of five cancer medicines. Read More
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 using FDA user fee legislation as a vehicle to cut drug prices. Read More