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).
CAJICA, Colombia – A cooler box with 70 vials allegedly filled with counterfeit COVID-19 vaccines seized from a Chinese couple in Colombia’s El Dorado International Airport on Feb. 17 underscored the growing challenges facing pharmaceutical companies, law enforcement authorities and health care regulators around the world. Patient safety, company liability, and the security of distribution channels have all been areas of growing concern.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dr. Reddy’s, Dynavax, Immunicum, Immunocore, Incyte, Janssen-Cilag, Junshi, RDIF, Travere.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Algernon, AMR, Cleveland Biolabs, Cytocom, Evolus, Fordoz, Jaguar, Life Biosciences, Lipomedix, Medytox, Metabolon, Novavax, Precision Biosciences, Sensorion, SXT, TFF.
If the SARS-CoV-2 virus has achieved anything useful in the world of in vitro diagnostics, it’s that the associated pandemic has shone a bright and unsparing light on the respective merits of diagnostic and surveillance testing. Harvard University’s Michael Mina, an assistant professor of epidemiology, was one of several academic researchers who took up the gauntlet yet again in opposition to what they characterized as a gross misunderstanding of the respective roles of these types of tests, a misunderstanding they said must be addressed if the pandemic is to be corralled.
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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agilent, Clearpoint Neuro, Exem Foam, Healthmode, Mindmed, New Horizon Health, Philips, Viewpoint Molecular Targeting.
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.
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