Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C). That’s cold but not nearly as cold as the mRNA-based vaccine’s emergency use authorization label calls for, which is storage in an ultra-cold freezer at temps of between -112 to -76 degrees Fahrenheit (-80 and -60 degrees Celsius).
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astellas, Bridgebio, Insmed, Pharvaris, Perception, Woolsey.
Emitbio Inc., a life science company developing light-based therapies, is seeking emergency use authorization (EUA) from the U.S. FDA for its investigational device to treat mild to moderate COVID-19 infection at home. The portable, hand-held device works by directing precise wavelengths of visible light to the back of the throat and surrounding tissues. It is not yet available for sale in the U.S.
The U.S. NIH’s Feb. 17 announcement that it’s funding a study of the effects of remdesivir in treating COVID-19 in pregnant women is welcome news, but it begs the question of why it took so long given the risk of more severe disease in that population.
Just months after a modest IPO, shares of Immunome Inc. (NASDAQ:IMNM) climbed 75.6% on Feb. 18, closing at $39.01. Driving the momentum was an announcement that pseudovirus testing indicates that its antibody cocktail, IMM-BCP-001, appears capable of neutralizing several SARS-CoV-2 variants, an emerging challenge to currently available vaccines and pandemic management efforts.
Investing in biopharma has never been for the faint of heart. So headline figures unveiled from a clinical development success report during the BIO CEO & Investor Conference Feb. 17, putting the average likelihood of a drug entering phase I development ultimately achieving approval at 7.9% and the average drug development timeline at 10.5 years, appear largely unsurprising. But the addition of machine learning capabilities to the mix helped identify those factors that have the greatest impact on predictive outcome.
Aside from its place in the history books as a global pandemic that nearly locked down the world, COVID-19 could have a lasting, more positive legacy of finally opening U.S. biopharmaceutical clinical trials to greater diversity.
DUBLIN – The most solid conclusion that can be drawn from Immunic Inc.’s phase II trial of IMU-838 in hospitalized COVID-19 patients is that a reduction in the need for invasive ventilation is no longer a useful endpoint for studies of COVID-19 drugs.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Asklepios, Astrazeneca, Biophytis, Cidara, Eli Lilly, Evgen, Immunic, Inhibikase, Kintara, Mesoblast, Mind Medicine, Moebius, Pfizer, PTC, Redhill, Salarius, Scisparc, Selecta, Silence.
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