The HHS Advisory Committee on Immunization Practices that had mixed opinions in June on the necessity of boosters will have a chance to consider new data when it meets again Aug. 24. Since that June adcom, COVID-19 infection rates have risen steadily and the FDA allowed for a third dose of the mRNA vaccines in certain adults with compromised immune systems.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aequus, Alzamend, Aobiome, Arthrosi, Azurrx, Cellular Engineering Technologies, Eli Lilly, Endocan Solutions, ERS Genomics, Glow Lifetech, HCW Biologics, Ico, Jaguar Health, Lixte, Nirvana Life Sciences, Revision, Satellos, Senhwa, Valeo.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carrick, Edgewise, Eli Lilly, Enlivex, Galmed, Inxmed, Jupiter, Merck & Co., Oncolys, Pfizer, Sesen, Therapeutic Solutions.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has cleared Speedx Pty Ltd.’s PlexPCR SARS-CoV-2 test, which detects all current circulating variants of the SARS-CoV-2 virus at a time when most of the country is in lockdown as the delta variant circulates.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Eli Lilly, Exact Sciences, Genotests, Insulet, Jenavalve, Photocure, Thermo Fisher Scientific.
Clinical data in 2021 has risen by about 9.2% in comparison with the same timeframe in 2020. As of mid-August, BioWorld has tracked a total of 2,400 entries of clinical data, which is up from the 2,197 entries last year. The gap has decreased from about 26% in mid-April, suggesting a steady slowdown in activity.
The CDC’s Advisory Committee on Immunization Practices (ACIP) deliberated the matter of third COVID-19 shots, with panel members voting whether to recommend “additional doses of mRNA COVID-19 vaccines as part of a primary [two-shot] series” in certain immunocompromised patients. A work group set up by ACIP decided previously that the desirable consequences outweighed undesirable ones in such a population.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aprea, Biontech, Cytodyn, Immune-Onc, Ipsen, Jazz, Moderna, Novatek, Pfizer, Rigel.
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