Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Amgen, Astrazeneca, Brainstorm, Cassava, Celsion, Curocell, Intra-Cellular, Junshi, Supernus, Zosano.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: BD, Brainstorm Cell Therapeutics, Gala Therapeutics, Integral Diagnostics, Lightdeck Diagnostics, Lucid Diagnostics, Medica, Mediwound, Nuprobe, Paragonix, Pavmed, Pre Diagnostics, Scanwell Health, Seaspine, Solys Diagnostics, Spineway, Tsunami Medical.
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.
RSS
