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).
HONG KONG – Hansoh Pharmaceutical Group Co. Ltd. picked up the greater China rights to Scynexis Inc.’s lead candidate, ibrexafungerp. Under the terms, Hansoh will take charge of the development, regulatory approval and commercialization of the antifungal in the region in exchange for a $10 million up- front payment and as much as $112 million in development and commercial milestones, plus low double-digit royalties on net product sales.
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.
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.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: BD offers little detail in reaction to advisory hearing; FDA invites stakeholders to user fee negotiations; MHRA wary of paclitaxel.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Additive Orthopaedics, FX Shoulder, Medtronic.
Athenex Inc.’s launch of Klisyri (tirbanibulin) likely whetted investor appetite for another prospect coming down the pike: Oraxol, an oral form of paclitaxel for which the Buffalo, N.Y.-based firm has been assigned a PDUFA date of Feb. 28.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Avacta, CNS, Seagen, WPD.
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