Government
Numerous top biopharma executives met recently in Manalapan, Florida for the R&D Leadership Summit. Although a wide range of topics were discussed, certain areas rose to the top as being of particular concern to industry leadership. Here’s a look at a few of those concerns.
Today, Celgene submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its ozanimod for adults with relapsing forms of multiple sclerosis (RMS).
Falsified Data Forces Duke to Pay $112 Million Settlement, Other Universities Under Scrutiny as Well
Duke University has agreed to pay the U.S. government more than $112 million to settle allegations that a university-associated researcher falsified claims in order to obtain funding from the National Institutes of Health and other federal agencies.
Both Bayer and J&J claim the lawsuits are without merit but believe that the $775 million settlement will allow the companies to move on from costly litigation.
A U.S. Food and Drug Administration (FDA) advisory panel voted 14 to 0 against recommending Neuronix’s NeuroAD system for the treatment of mild to moderate Alzheimer’s disease.
As America continues to grapple with the opioid crisis, nonprofit advocacy group Public Citizen is calling for the U.S. Food and Drug Administration to place a moratorium on the approval of any new opioid medications.
The Roche lawsuit claims that Utah-based Alliance Medical acquired the test strips through a Roche mail order plan and then resold them at a higher price.
The United Food and Commercial Workers Local 1500 (UFCW Local 1500) filed a class action lawsuit against AbbVie for allegedly using a group of patents to maintain a monopoly on its blockbuster Humira (adalimumab).
As Scott Gottlieb prepares to step down from his role as commissioner of the U.S. Food and Drug Administration, he sat down with Politico to talk about his two years at the helm of the regulatory agency and what regrets he may be leaving behind.
The FY19 Defense Appropriation provides $7.5 million to the Department of Defense Autism Research Program to provide support for research of exceptional scientific merit and innovation with high impact that focuses on autism spectrum disorders.
PRESS RELEASES