Shares in Valneva SE fell sharply after the company said European regulators came back with further queries, including on antibody efficacy data, instead of a recommendation during a rolling review of its delayed COVID-19 vaccine. The company had expected a positive opinion on the vaccine, known as VLA-2001, following the April meeting of the European Medicines Agency’s CHMP committee.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Biogen, Direct, Incyte, Lynk, Medac, Medexus, Novartis, Revance.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelrx, Assembly, Arrowhead, Astellas, Biotest, Grifols, Medigene, Nektar, Portage, Porton, Sinorda, Stimunity, Tiancheng, Turnstone, Visirna, Wave and Xbiome.
By January 2022, 12 billion COVID-19 vaccine doses had been manufactured and, to date, roughly 20 vaccines have received either full approval or emergency use authorization in countries around the world. In places such as Europe and the U.S., most of the people who want vaccinations have gotten their jabs. And the vaccines continue to show efficacy, with the latest CDC data showing consistently less risk for testing positive for COVID-19 or dying from the infection for those who are vaccinated and boostered. Yet the development of new COVID-19 vaccines remains surprisingly robust, with BioWorld tracking 258, the majority of which are in preclinical development.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ampio, Dragon Boat, Hansa, Moleculin, Nrx, Otsuka, Tvardi, Vertex, Zambon.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alzecure, Arev, Celsion, Codiak, Gilead, ICER, Immune-Onc, Janssen, Legend, Pfizer, Sanofi, Terran, Vallon.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adiso, Astrazeneca, Epicentrix, Maat, Novavax, Orasis, Servier.
Astrazeneca plc led the handful of firms rolling out COVID-19-related news, as the company said detailed results from the Provent phase III pre-exposure prophylaxis (prevention) trial with Evusheld (tixagevimab and cilgavimab), were published in the New England Journal of Medicine, the “culmination of about 19 months of pretty intensive work,” said Mark Esser, vice president of microbial sciences.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clarius Mobile Health.
RSS
