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Two plans — one from Operation Warp Speed and one from the Centers for Disease Control and Prevention — for distributing a COVID-19 vaccine are short on crucial details and leaves much of the distribution to state and local authorities. Read More
Sponsors of clinical trials for drugs or biologics to treat eosinophilic esophagitis, a chronic disease in which white blood cells inflame the esophagus, should note a change to how the FDA recommends they analyze the data. Read More
Drugs and biologics may fit into one of four categories when it comes to their use in patients age 65 and up, the FDA says in a new draft guidance on geriatric information for prescription product labeling. Read More
The FDA has hit Mallinckrodt Pharmaceuticals with a second complete response letter (CRL), denying approval of its new drug application (NDA) for terlipressin for the treatment of adults with hepatorenal syndrome type 1(HRS-1) and calling for more data. Read More
A top Roche executive slammed President Trump’s expanded “most favored nations” executive order as an unwise and overreaching policy for reducing U.S. drug prices, contending that the president’s own economic advisers found foreign price comparisons would hinder access to new medicines. Read More
The head biosafety expert for China’s Center for Disease Control and Prevention has claimed that the country could have a vaccine ready for general population use as soon as November, touting the country’s rapid progress on COVID-19 vaccine development. Read More
Novavax has expanded its COVID-19 vaccine manufacturing agreement with the Serum Institute of India to produce more than 2 billion doses of the vaccine annually. Read More
In letters sent yesterday, leaders of the House Energy and Commerce committee urged nine companies developing COVID-19 vaccines to uphold their pledge to maintain high ethical standards and to commit to transparency in making all clinical trial data on their vaccines publicly available. Read More
The National Institutes of Health (NIH) is deeply concerned that an unexplained patient illness under review in AstraZeneca (AZ)’s phase 3 COVID-19 vaccine trial could throw the promising candidate off course, and the NIH has opened its own investigation into the issue, an NIH clinical director has disclosed. Read More