China’s National Medical Products Administration granted conditional approval two Chinese-developed COVID-19 vaccines in less than 24 hours on Feb. 25. One of the vaccines approved was developed by Tianjin-based Cansino Biologics Inc., and the other by China National Pharmaceutical Group (Sinopharm) through its Wuhan Institute of Biological Products subsidiary.
HONG KONG – Wuxi Diagnostic Investment (Cayman) Ltd. has raised $150 million in a series B financing round, while netting a number of new investors along the way. The new investors to come on board include Thermo Fisher Scientific Inc., Shiyu Capital, ABC International Holdings Ltd., Sunland Capital and CCBI Tech Venture.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: American Cryostem, Assure Holdings, Biotherapeutic Labs, Bird & Cronin, Caredx, Cerus, Charles River Laboratories, Clinical Reference Laboratory, Co-Diagnostics, Collplant Biotechnologies, Dynatronics, Grin, Henry Schein, Icon, Illumina, Imaging Endpoints, Intalere, Kibur Medical, Neovasc, New England Biolabs, Oxford Nanopore Technologies, Patientslikeme, PRA Health Sciences, Protembis, Puretech Health, Renalytix AI, Rubiconmd, Sentry Neuromonitoring, Shandong Zhongbaokang Medical Implements, Siren Care, Smiledirectclub, SQN Clinical, Transchart, TX Services, United Therapeutics, Veristat, Walgreens.
The U.S FDA’s response to the pandemic has been all-consuming, but epidemiologist Michael Mina of Harvard blasted the agency’s handling of rapid testing. Mina said the agency is in possession of emergency use authorization filings for rapid antigen tests that should be acceptable, but that the FDA is “the only bottleneck” in the rapid antigen testing pipeline.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Assure Tech, Dascena, G21, Locate Bio.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptive Biotechnologies, Astarte Medical, Evasc Neurovascular, Genesiscare, Icometrix, Labcorp, Medcura, Neuroone, Perkinelmer, Personal Genome Diagnostics, Pixcell, Soliton, Stevara, Transenterix, Zimmer Biomet.
In the shadow of the COVID-19-related deaths of more than half a million Americans and far more deaths across the world, the Biden administration is reportedly rethinking its position on a proposal before the World Trade Organization to waive intellectual property protection for SARS-CoV-2 vaccines.
Lexagene Holdings Inc. has successfully configured its Miqlab system to detect the U.K. and South African variants of SARS-CoV-2. The open-access point-of-care system can simultaneously screen for multiple respiratory pathogens and identify COVID-19 strains. Lexagene started studies to support its filing for U.S. FDA emergency use authorization (EUA) in late December 2020. If authorized, it would be the first open-access point-of-care (POC) device to gain an EUA.
LONDON – The first population-level real-world data on COVID-19 vaccines indicate they are having a dramatic impact on severe disease, with a study in Scotland showing a fall of 85% in hospital admissions for people who received the Pfizer Inc./Biontech SE product, and a drop of 94% for those who had Astrazeneca plc’s vaccine, four weeks after receiving the first dose.
