Policy

FEATURED STORIES
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former U.S. Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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Amid news of a whistleblower lawsuit, Mallinckrodt Pharmaceuticals (MNK:NYSE) shares dropped 9.51% yesterday.
The U.S. Food and Drug Administration (FDA) finalized two separate guidances for next-generation sequencing technologies.
One month after three patients who developed adverse reactions following injections of an unauthorized herpes vaccine filed a lawsuit against Rational Vaccines, the U.S. Food and Drug Administration has launched a criminal investigation into the matter.
Sarepta Therapeutics is breathing a little easier this morning. On Wednesday a federal appeals court supported a previous court’s decision to dismiss charges that the company misled shareholders as it vied to gain approval for its Duchenne muscular dystrophy treatment.
As legal battles over opioid drugs slowly move through the courts the U.S. Department of Justice is adding its weight to the matter. This week the DOJ asked the courts for permission to help settle disputes brought by state and local governments against opioid manufacturers and distributors.
Company shares spiked 12.4 percent higher in premarket trading today after the U.S. Food and Drug Administration (FDA) granted Proteostasis Therapeutics’ triple combination for cystic fibrosis (CF) Fast Track Designation.
Amgen gets to breathe a small, but temporary sigh of relief as a court case determining whether or not Novartis subsidiary Sandoz can launch its biosimilar challenge to blockbuster rheumatoid arthritis drug Enbrel has been delayed.
Novartis filed a federal lawsuit against a former executive, Alisha Alaimo. The lawsuit alleged that Alaimo stole confidential files using a flash drive before joining Biogen.
As Endo International faces a number of lawsuits related to its opioid-painkiller, the company has agreed to extend a temporary stay of its own lawsuit against the U.S. FDA.
Days after being tapped to helm the U.S. Centers for Disease Control and Prevention, Dr. Robert Redfield predicted the AIDs epidemic can be defeated within the next three to seven years and the challenges of the opioid crisis can also be brought “to its knees.”