Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lightpoint Medical, Omniguide Holdings, Renegade.bio.
LONDON – There’s mixed news about emerging variants of SARS-CoV-2, with Pfizer Inc. and Biontech SE reporting their vaccine Comirnaty maintains its protective effect against B 1.1.7, first detected in the U.K., while researchers in South Africa say virus variant 501Y.V2 is able to escape neutralization by both monoclonal antibodies and convalescent plasma from previously infected individuals.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Aptorum, Arcutis, Astrazeneca, Biocelect, BMS, Daiichi, Eutilex, Haisco, Histogen, Impel, Lytix, Merck, Novo Nordisk, Sobi, Taysha, Terns.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alkermes, Apnimed, Eloxx, Evelo, Faron, Forma, Jemincare, Ocular, Ocuphire, Seneca, Sumitomo, Dainippon, Synairgen, Theralase, Tris.
PERTH, Australia – The majority of medical device and biopharma industry respondents agreed that Australia’s Therapeutic Goods Administration (TGA) responded effectively to COVID-19, but they want to see the agency improve its processes to act faster and with more clarity, according to the TGA’s annual stakeholder survey.
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