LONDON – A huge row has broken out in the U.K. about the accuracy and utility of COVID-19 lateral flow tests (LFT) in screening asymptomatic people, as a pilot field study indicated sensitivity is less than 40%, and a nationwide roll out already is in train. At present 116 areas of the country are due to implement community testing from next month, health care workers are due to be handed personal LFT supplies to test themselves twice a week, and the government is about to mandate use of the tests in schools after Christmas.
Hopes continue to rise as the COVID-19 vaccine beat goes on and Operation Warp Speed (OWS) lives up to its name, with Moderna Inc. netting another U.S. Department of Defense contract worth about $1.97 billion for another 100 million doses – an order that brings to about $6 billion the company’s government contracts for the product, which was granted emergency use authorization (EUA) earlier this month.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Distalmotion, Inex Innovate, Quanterix.
The amount of money flowing into the biopharma industry via grants and collaborations with nonprofit and government entities is a 272% increase over last year, with efforts to fight the COVID-19 pandemic accounting for 84% of the total for 2020.
PERTH, Australia – Australia is employing some new genomic tools to help identify SARS-CoV-2 infections and track them within communities. Illumina Inc. and the University of Melbourne have partnered to establish the Illumina-University of Melbourne Genomics Hub – a first for the Asia-Pacific region – which will bring together the best of genomic expertise and technology in Australia.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Ampio, Arcturus, Capricor, Celltrion, Clovis, Chi-Med, Moleculin, Novo Nordisk, Pfizer.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arcturus, Biontech, Brand Institute, Cognition, Innovare, Junshi, Karolinska, Olatec, Pfizer, Pluristem, Umecrine.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinium, Arcturus, Intra-Cellular, Nanology, VBL.
HONG KONG and BEIJING – China’s Sinovac Biotech Ltd. delayed releasing trial data from its Coronavac COVID-19 vaccine while the National Medical Products Administration (NMPA) accepted an NDA from China National Biotec Group (CNBG) for its own vaccine, BBIBP-CorV.
TORONTO – It took the Vancouver, British Columbia-based biotech three times, but before the week in mid-December was over, Abcellera Biologics Inc. had finally closed its IPO on the Nasdaq, hoovering up gross proceeds of $555.5 million.
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