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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The FDA released a draft guidance yesterday with proposed recommendations for making changes to the labeling of a previously approved oncology drug that describes how to use the drug in a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
The company aims to “be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021,” said CEO Stéphane Bancel. Read More
The FDA issued a complete response letter (CRL) to Sanofi for sutimlimab, an investigational monoclonal antibody for treating hemolysis in adults with the rare autoimmune condition, cold agglutinin disease. Read More
Alkermes was slapped with a Complete Response Letter from the FDA regarding its new drug application (NDA) for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder. Read More