Results of a futility analysis prompted Regeneron Pharmaceuticals Inc. to continue the phase III study of its virus-neutralizing monoclonal antibodies, a REGN-10933 and REGN-10987 cocktail for treating hospitalized COVID-19 patients who are seronegative and need low-flow oxygen.
HONG KONG – China National Biotec Group (CNBG) said that BBIBP-CorV, one of the two COVID-19 vaccines it currently has under development, provides 79.34% protection against the coronavirus. Volunteers who received the vaccine in the phase III experiment produced high-tier antibodies, with a neutralizing antibody positive conversion rate of 99.52% after two doses, the company said.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biocure, Chi-Med, Lygenesis, Osmotica, Pharos Vaccine, Tetra, Tracon.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arcturus, Moderna, Propanc, Vaxil, Vistagen, Wize.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Altimmune, Chiesi, Codiak, Emergent, Hepion, Lipocine, Neurorx, Nicox, Protalix, Regeneron, Sinopharm.
LONDON – The COVID-19 vaccine developed by Astrazeneca plc and Oxford University has been approved by the U.K regulator, with the first doses being shipped on Dec. 30 and a mass vaccination program due to begin on Jan. 4. AZD-1222, now named COVID-19 Vaccine Astrazeneca, is authorized for emergency use and will require two doses for durable effect.
It has been a year since Wuhan health authorities first issued a bulletin about a cluster of pneumonia cases of unknown cause, first bringing what would become the COVID-19 pandemic to the attention of the World Health Organization. Now, a mutation that significantly increases SARS-CoV-2’s transmissibility has been detected in the U.S. On Dec. 29, Colorado public health authorities reported the first known case of infection with the SARS-CoV-2 VUI 202012/01 (Variant Under Investigation, year 2020, month 12, variant 01), also called B.1.1.7, variant in the U.S. The patient in question, a male in his 20s, has not traveled internationally, indicating that the variant is already circulating more widely in the U.S.
Coagulo Medical Technologies Inc. raised $6.5 million in financing to accelerate delivery of its precision-medicine coagulation diagnostics platform. 20/20 Healthcare Partners led the investment with participation from Sands Capital, Good Growth Capital, IAG Capital Partners, and private investors. The company also received funding through a Small Business Innovation Research (SBIR) grant from the National Science Foundation to develop a COVID-19-related coagulation test.
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.
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