Determining whether a risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) is doing the job is proving to be quite a challenge in the absence of definitive, comparative patient-outcome data.
WASHINGTON – With the nation's drug shortage crisis depriving patients of critical treatments and threatening the development of new drugs, lawmakers must address the root causes of the problem – government pricing and regulatory policies that have created a "race to the bottom," a House subcommittee was told.
Making risk evaluation and mitigation strategies (REMS), especially those with elements to assure safe use (ETASU), more effective and less burdensome is a tall order. So the FDA is turning to the experts for advice on assessing those REMS.
WASHINGTON – When it comes to the economic adulteration of drugs, an ounce of prevention could end up costing the biopharma industry what it considers confidential information.
Big pharma and biotech start-ups have embarked on a federated mission to explore the expansive chemical space between small molecules and biologics to seek out new therapies that will boldly go where no drugs have gone before.
Having raised $89 million in its latest financing round, Portola Pharmaceuticals Inc. is preparing to fly solo on its pivotal Phase III trial that will evaluate betrixaban in the prevention of pulmonary embolisms.
WASHINGTON – Citing a lack of proof that the benefits outweigh the risks, FDA Commissioner Margaret Hamburg revoked the agency's approval of the breast cancer indication for Genentech Inc.'s Avastin.
With drug prices continuing their upward climb, several senators are launching bipartisan efforts to shoot them down with increased competition. And that's putting pay-for-delay settlements at the center of congressional crosshairs.
Incyte Corp. scored two firsts with Jakafi, its first product out the pipeline: It's the first JAK inhibitor approved by the FDA. And it's the first drug approved to treat the bone marrow disease myelofibrosis.
