With shortages of the COVID-19 drug, remdesivir, being reported in several states in India, the country’s Central Drugs Standard Control Organization is calling on state regulators to “immediately initiate remedial action to ensure supply of remdesivir injection to public and private hospitals.”
If the U.S. Congress is receptive to recommendations approved by the Medicaid and CHIP Payment and Access Commission (MACPAC) April 9, the FDA's accelerated approval path for innovative new drugs could lose a bit of its appeal. And sponsors using that path may speed the pace of seeking full approval.
PERTH, Australia – The Australian government is recommending that Australians under 50 take the Pfizer Inc. COVID-19 vaccine due to the risk of rare blood clots associated with Astrazeneca plc’s COVID-19 vaccine (ChAdOx1-S). The move jeopardizes Australia’s vaccine rollout as it had planned for the majority of Australians to receive the Astrazeneca vaccine, which is being locally manufactured by CSL Ltd.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Airway, Akari, Biontech, Generex, Genmab, Jazz, Junshi, Nugenerex, Pfizer, Resverlogix, Scolex, Seagen, Sorrento.
The FDA told Provention Bio Inc. that its BLA under priority review for teplizumab needs some work but the May 27 advisory committee meeting to discuss the application in full is still on the calendar.
In the debate over the interpretation of the U.S. government’s patent march-in rights under the Bayh-Dole Act, those arguing for march-in as a price control cite the billions of tax dollars being invested in scientific research at universities that may lead to marketable inventions.
LONDON – The EMA has concluded that the rare cases of serious blood clots with low platelet counts seen after administration of Astrazeneca plc’s COVID-19 vaccine are caused by the vaccine, but said the benefits of its use continue to outweigh the risks. The possibility of cerebral venous sinus thrombosis and splanchnic vein thrombosis in the abdomen will now be listed as rare side effects and the EMA’s guidance to health care professionals will be updated.
Fibrogen Inc. said senior management’s prep for an upcoming FDA advisory committee meeting included a surprise. The internal review unearthed a primary cardiovascular safety analysis of roxadustat for treating anemia of chronic kidney disease (CKD) that included post-hoc changes to the phase III study’s stratification factors.