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.
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.
HONG KONG – In a surprisingly candid statement, the director of China’s Centers for Disease Control conceded that the efficacy of Chinese coronavirus vaccines is "not high" and may require improvements. George Gao, the director of China’s CDC, stated that Chinese vaccines “don’t have very high protection rates” at the National Vaccines and Health conference in the southwestern city of Chengdu on Saturday.
NASA is ready to begin testing the E-Nose COVID-19 screening device prototype developed by subcontractor Variable Inc., of Chattanooga, Tenn. NASA received $3.8 million from the Department of Health and Human Services to enhance E-Nose, which was originally developed to measure air quality inside spacecraft. The updated version is intended to facilitate screening for SARS-CoV-2 by "sniffing out" the signature volatile organic compounds (VOCs) in the breath of infected individuals.
COVID-19 has caused a surge in telemedicine, increasing access to health care without having to physically visit a doctor. In similar ways, it is changing things in the operating room, where advanced technology platforms enable surgeons and specialists to observe or weigh in on surgeries and allow manufacturer reps to assist in procedures using new devices.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS, DOJ officials highlight pandemic response needs; FDA says plenty of respirators available; NICE supports use of Danis for variceal hemorrhage.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biosig Technologies, Control Bionics, Genetic Technologies, Infinity Biologix, Lucira Health, Numotion, Outset Medical.
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