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Patent expirations, biosimilars and uncertainty around the Trump administration’s drug policies will create a pricing squeeze in the drug industry, according to a new analysis. Read More
The European Medicines Agency published a step-by-step guide for drugmakers to prepare for the implementation of the new EudraVigilance adverse event monitoring system, scheduled for Nov. 22. Read More
A new class-action lawsuit from a terminal blood cancer patient claims that Celgene abused consumer safety regulations to monopolize cancer drugs. Read More
Pharmakon Pharmaceuticals executives routinely sent drugs to hospitals without waiting for test results confirming the potency of the drugs matched their labels, and when results showed the strength was often nearly double what it should have been, covered up the error and lied to FDA investigators rather than notifying the FDA or customers, according to a 10-count federal indictment. Read More
The White House could be pushing for lower prices by way of speeding drugs to market and promoting competition—even internationally—according to a draft executive order that could have the president’s signature soon. Read More
To help drive down drug prices, the FDA plans to list drugs and drug categories where patent and exclusivity protection have expired, but no generic entrants are available, FDA Commissioner Scott Gottlieb said Monday, in his first address to the agency’s Science Board. Read More
The European Medicines Agency recommended eight new drugs for approval, including two combination treatments for hepatitis C, two therapies for advanced cancers and one drug for relapsing multiple sclerosis. Read More