The exceptional and speedy response in bringing safe and effective vaccines and therapeutics to combat COVID-19 has kept investors engaged and supportive. As a result, not only have companies involved in this research and development benefited, but so has the sector as a whole. Those biopharma companies have enjoyed significant jumps in their share values, with the BioWorld Drug Developers index closing up 4.6% in December and up 29% for 2020.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Arcturus, Ascentage, Atriva, Chipscreen, Cure, Genentech, Marius, Marker, Moderna, Ovoca, Precigen, Roche, Zosano.
The U.S. FDA’s device center may still be grappling with the COVID-19 pandemic throughout the remainder of fiscal year 2021, but that does not mean other considerations have disappeared. The FDA’s Erin Keith said the agency will keep working on a major overhaul of the quality systems regulation (QSR) but will also work toward expanding industry’s use of advanced manufacturing technologies, such as additive manufacturing.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Curative test for COVID should be conducted per product label; FDA posts MEA final guidance; CMS eyes radiology quality measures; Ra Medical agrees to fines.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allscripts, Aposhealth, Caredx, Casa Schmidt, Centene, Henry Schein, Integra Lifesciences, Magellan Health, Nextgen Biomed, Scent Medical Technologies, Si-Bone, Smith & Nephew, Virtue Health, Wellsky.
Keeping you up to date on recent developments in cardiology, including: Researchers outline new stroke strategy; Group assesses role of neutrophil extracellular traps in coronary thrombosis in COVID-19 patients; Link identified between metabolic syndrome and higher cardiovascular risk in patients with psoriasis.
NEW DELHI – The Drugs Controller General of India (DCGI) granted its first emergency conditional approvals Jan. 3 for a pair of COVID-19 vaccines, including Covishield, developed abroad by Astrazeneca plc and Oxford University and manufactured by the Pune-based Serum Institute of India (SII). The DCGI also approved Covaxin, which was developed locally by Hyderabad-based Bharat Biotech International Ltd. in collaboration with the Indian Council of Medical Research, and is still in phase III trials.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ambrx, Antengene, Arcturus, Atara, Ayala, Bioniz, BMS, Forge, Inozyme, Matinas, Opko, Passage, Pfizer, Provention.
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