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.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aim Immunotech, Biogen, Blue Water Vaccines, Humanigen, Immvira, Roche, Samsung Bioepis, Selva, Sihuan Pharma, Tonix, Xortx, Xuansheng Pharma.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arcturus, Bavarian Nordic, Clover, Fibrogen, Navidea, Otonomy, Snipr, Trevena, Ultragenyx, Windtree.
Arcturus Therapeutics Holdings Inc. reported that ARCT-154, its self-amplifying mRNA COVID-19 vaccine, showed efficacy of 55% against infection and 95% efficacy against severe disease, meeting the primary and key secondary endpoints of the ongoing phase I/II/III trial. While the company’s stock (NASDAQ:ARCT) regained much of its initial 25% drop to close the day, investors continue to await further data to determine where Arcturus’ vaccine will fit in with available COVID-19 vaccines.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: The Orthopaedic Implant Company, Zeiss.
The U.S. COVID-19 vaccine program is at risk of “booster fatigue,” which will undermine public confidence in the vaccines, several members of the CDC’s Advisory Committee on Immunization Practices (ACIP) said April 20 as they met to discuss the future of the vaccines. Rather than relying on boosters, “we need to use our expertise to advocate for something that’s better,” something that resolves the ill effects of COVID-19, whether it’s mild or severe, said Lynn Bahta, an immunization program clinical consultant for the Minnesota Department of Health.
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