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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adicet, Astrazeneca, Axsome, Aytu, Daiichi Sankyo, Hansa, Innovative Cellular, Merck, Navidea, Novavax, NTC, Ribomic, Serum Institute, Takeda..
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Aclipse, Aptinyx, Benevolentai, Diamyd, Dragonfly, Endevica, Heat, Hoth, Neuropore, Nextcure, PDS, Pharmacyte, Soligenix, Therapeutic Solutions.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acadia, Amgen, Beigene, Bioage, Biorestorative, Clover, Cyclacel, Kempharm, Moderna, Neuraly, Synaptogenix, TFF, Urovant.
The U.S. FDA’s device center reported April 18 that it has revoked the emergency use authorizations (EUAs) for five tests for the SARS-CoV-2 virus, a seemingly significant reduction in the inventory of tests for the COVID-19 pandemic. However, the sponsor of the test in each of these revocations requested that the EUA be revoked, an indication that the market for some types of these tests is saturated.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bendit Technologies, Cosara, Genetron, Ihealthscreen, Microgem, Smart Medical Systems.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Beigene, Novartis, TG.
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