Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axsome, Direct Biologics, Lexicon, Netris, Redhill.
Chinese regulators granted a first approval for general use to a COVID-19 vaccine to China National Biotec Group’s (CNBG) BBIBP-CorV. “The NMPA granted conditional approval to the vaccine on Dec. 30,” said Chen Shifei, deputy head of the National Medical Products Administration (NMPA) during a Dec. 31 press conference. The company is required to continue with phase III trials as planned, submit subsequent data and report any adverse reactions.
Two-Photon Research Inc. (TPR) has launched a diagnostics platform it said improves coronavirus detection via aptamers, small molecules that change shape when binding to a protein at the surface of the SARS-CoV-2 molecule that causes COVID-19. Light shone onto a vial containing a patient’s saliva and the Aptamer Molecular Photonic Beacon (AMPB) generates negative or positive results that are instantly displayed on a smartphone and stored for planning purposes by public health officials.
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.
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