The FDA and the CDC have jointly recommended a temporary pause in the further rollout of Johnson & Johnson Co.’s COVID-19 vaccine while they investigate six rare clotting cases in adults ages 18 to 48.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aprea, Provention, Ryvu, Syndax, Therapeuticsmd.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Cansino, Cytodyn, Gilead, Immutep, Teva.
RSS
