With the FDA’s required safety milestone notched in their phase III study of COVID-19 vaccine candidate BNT-162b2, Pfizer Inc. and Biontech SE said they will request emergency use authorization “within days.”
Concerns about biopharma executives profiting from stock sales aligned with releases of promising COVID-19 vaccine results could result in Congress requiring a cooling-off period for executives’ 10b5-1 plans that provide a safe harbor to insider trading.
A new report on the biopharma industry by cybersecurity firm Bluevoyant LLC found that the eight most prominent players in the race for a COVID-19 vaccine faced the highest volume of targeted, malicious cyberattacks, and 77% of the total 20 companies examined had unsecured remote desktop protocol (RDP) ports and email domains lacking basic measures to block hackers. “COVID-19 vaccines are the crown jewels of 2020 – and cyber attackers know it,” the report says.
In a world where the traditional way of conducting business has been disrupted for most of the year, companies for the most part appear to have adapted well to the prevailing environment. BioWorld conducted a short poll to determine readers’ own experiences during these challenging times and how they believed this new normal might reshape their approach to doing business going forward.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Phage, Biogen, Bioventus, Cellectis, Cormedix, Janssen, Nanobiotix, Omeros, Pfizer, PTC, Samsung, Sanofi, Vivet.
The question of whether the U.S. FDA will review emergency use authorizations (EUAs) for lab-developed tests (LDTs) for the COVID-19 pandemic has bounced around frequently in recent weeks, and Brett Giroir of the Department of Health and Human Services has resurrected the issue.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3D Systems, Allotrope Medical, Co-Diagnostics, Hologic, Safkan, Sommetrics, Tissium.
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