Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Impedimed, Phase Scientific, Vapotherm, Visby Medical.
The CDC’s Advisory Committee on Immunization Practices (ACIP) heard a safety update on COVID-19 vaccines, took up the matter of booster shots, and voted on whether to recommend the vaccine from Pfizer Inc. and Biontech SE for people 16 and older, now that it’s fully licensed. Under an emergency use authorization, the vaccine can be given to people 12-15 years old.
New data from Nrx Pharmaceuticals Inc.’s phase IIb/III trial for treating acute respiratory failure due to critical COVID-19 showed that Zyesami (aviptadil) improved the lung’s ability to transmit oxygen within a day of administration. The respiratory distress ratio’s average difference between those participants receiving aviptadil and placebo was clinically meaningful and statistically significant. The benefit was found across participants, all baseline severities and hospitals of all types.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Immunobrain, Insilico, Noxopharm, Satellos, Sorrento, Tilt, Tumorgen.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Aileron, Airway, Alzecure, Amgen, Ose, Quantum.
The FDA has issued an emergency use authorization (EUA) for Becton, Dickinson & Co.’s (BD) Veritor At-Home COVID-19 test – a rapid COVID-19 digital antigen test. The test, which is designed for home use, uses a mobile app from Los Angeles-based Scanwell Health Inc. that provides instructions on how to collect and transfer the nasal swab sample to the test stick. The smartphone camera is then used to capture, analyze and interpret results within 15 minutes. BD said it will initially be rolled out to businesses, schools and governments looking to provide a self-testing option.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Microtransponder.
A fully approved COVID-19 vaccine, clinical advances of pandemic antibodies and multibillion-dollar deals appear to be the driving forces of increasing biopharma stock prices. BioWorld’s Biopharmaceutical Index is tracking ahead by 10.6% this year, after several months of negative numbers.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Ascendis, Astrazeneca, Biocryst, Biontech, Exelixis, Ironwood, Marinus, Merck, Ono, Pfizer, Scancell, Servier, Sesen, Takeda, Vertex, Zogenix.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acasti, Alpha Healthcare Acquisition, Beigene, Bio-Thera Solutions, Bolt, Grace, Hikma, Humacyte, Immix, Innovent.
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