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.
WASHINGTON – With yet another deadline looming this week, a congressional conference committee has come to terms on a "minibus" bill that includes a 2012 budget for the FDA of nearly $3.8 billion.
Both the FDA and Salix Pharmaceuticals Inc. will be looking to members of the Gastrointestinal Drugs Advisory Committee Wednesday for answers on designing a clinical trial to demonstrate the safety and efficacy of an antibiotic intended to be used intermittently to treat a chronic condition.
In lieu of a much-promised and oft-delayed guidance on social media, biopharma has been told to apply existing guidance on drug promotion to online communication. But in many instances, that's like trying to fit a square peg into a round hole.
