Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akouos, Avenue, Axcella Health, Celularity, Janssen, Kibow, Lintonpharm, Neuraptive, Novartis, RDIF, Vtv.
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.
LONDON – A large scale prospective study has shown that increased blood plasma viscosity is correlated with disease severity and the likelihood of progression to organ failure, in patients who are hospitalized with COVID-19 infections. Researchers at Addenbrooke’s Hospital in Cambridge, U.K. suggest this could be an easy but sensitive way to quickly triage patients admitted to hospital with symptoms of COVID-19.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cosmo, Lucira Health, Masimo, Medtronic, Myhomedoc, Thermo Fisher Scientific.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Angiodynamics, Avantor Performance Materials, Diasorin, Luminex, Mediphos Diagnostics Belux, Respicardia, Technomed, Zoll Medical.
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.”
Among a spate of COVID-19-related therapy developments to start the week, Kiniksa Pharmaceuticals Inc. produced positive phase II data of its monoclonal antibody, mavrilimumab, in treating non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation.
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.
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