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.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alkermes, Ascletis, Biocytogen, Bridge, Coeptis, Ctm, Eagle, Finch, Imara, J&J, Shaperon.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Black Diamond, BMS, Emergex, Kinnate, Lumen, Nektar, Revive.
The FDA has granted an emergency use authorization (EUA) to Inspect IR Systems LLC, of Frisco, Texas, for the company’s namesake test that evaluates the patient’s breath for the presence of volatile organic compounds (VOC) indicative of the SARS-CoV-2 virus. The test is expected to increase the volume of testing by only 64,000 per month at the current rate of production, however, making this a technological breakthrough of limited impact on the COVID-19 pandemic.
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