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The National Institutes of Health (NIH) should disclose more information about the licensing of its intellectual property and the impact on the affordability of drug products, the Government Accountability Office said in a new report to Congress. Read More
The FDA will analyze initial promotional materials from drug companies within five business days of receiving them to see if they qualify for priority “core launch” review, said Susannah O’Donnell, leader of the review team in the agency’s Office of Prescription Drug Promotion (OPDP) in a Friday update on the program. Read More
The World Health Organization (WHO) released revised guidance on Gilead Sciences’ antiviral Veklury (remdesivir) after an expert panel review of multiple trials found no evidence for the drug’s effectiveness in treating COVID-19. Read More
The Trump administration on Friday rolled out a pair of final rules meant to reduce high U.S. drug prices, including the “most favored nations” strategy strongly opposed by the pharma industry, possibly marking the president’s last significant actions on drug pricing. Read More
Better communications between the FDA and sponsors, and more clarity from the agency on the issue of interchangeability, were among the suggestions from industry yesterday at a public meeting on the next iteration of the user fee program under the Biosimilar User Fee Act of 2017, dubbed BSUFA III. Read More
The FDA released a draft guidance yesterday with proposed recommendations for making changes to the labeling of a previously approved oncology drug that describes how to use the drug in a combination drug regimen. Read More
The FDA has not been fully transparent about its Emergency Use Authorizations (EUAs) for COVID-19 treatments as it “does not uniformly disclose” its scientific review of safety and effectiveness data for EUAs, as it does for approvals for new drugs and biologics,” the Government Accountability Office said in a new report to Congress. Read More
A New York bankruptcy judge ruled Tuesday to allow Purdue Pharma’s owners to give up $225 million to the government as part of a larger settlement for the company’s role in the opioid crisis, though the rest of the controversial $8.3 billion agreement still needs to be approved by the court. Read More
The U.S. House of Representatives has passed a bipartisan bill that aims to stop drugmakers from using a loophole that has allowed them to hold exclusivity on an orphan drug well after the seven years established in the Orphan Drug Act of 1983. Read More