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.
HONG KONG – Peptidream Inc. has partnered with four other Japanese companies to research and develop peptide therapeutics capable of neutralizing the SARS-CoV-2 virus as well as potential future coronavirus outbreaks. Peptiaid Inc., the joint venture established with Fujitsu Ltd., Mizuho Financial Group Inc. subsidiary Mizuho Capital Co. Ltd., Takenaka Corp. and Kishida Chemical Co. Ltd., will have capital totaling ¥599 million (US$5.73 million) by Dec. 31.
The latest global regulatory news, changes and updates affecting biopharma, including CDER, CBER promise EUA transparency; FDA plasma guidance updated, again; WHO targets cervical cancer; Draft guidance to help FDA respond to 2012 citizen petition; More time to comment on instituting PTAB trials.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Apellis, Azurrx, BMS, CNS, Cytodyn, Inovio, Istari, Kiniksa, Moderna, Plx, Praxis, Redhill, UCB, Verrica, Viiv.
LONDON – Results from the phase I/II trial of Coronavac, a COVID-19 vaccine based on a traditional inactivated whole SARS-CoV-2 virus that circulated in China in the early days of the pandemic, show it is safe and induces an antibody response in healthy volunteers ages 18 to 59.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Vaccine, diagnostic developers targeted by cyberattacks; Groups make case for extending sequester moratorium; More money needed for global vaccine effort; Russia extends COVID-19 drug, device program.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chembio, Sofwave.
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