LONDON – A follow-up study of participants in the phase II/III U.K. trial of Astrazeneca plc’s COVID-19 vaccine has shown it remains effective against the new B.1.1.7 variant of SARS-CoV-2.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Commonwealth Diagnostics International, Real Time Medical Systems, Seqwell, T2 Biosystems, Zimmer Biomet.
Covicept Therapeutics Inc., a young San Diego-based company focused on developing a small molecule to inhibit the replication and spread of SARS-CoV-2 and other RNA viruses, has launched with $2.3 million in seed funding from European VC firm Forbion. The company, spun out of research at the University of California, San Diego, aims to initiate its first clinical study in the middle of 2021.
U.S. FDA warning letters have been a staple of regulatory life since the late 1990s, but James Boiani, a regulatory attorney with Epstein, Becker & Green P.C., said it’s no stretch of the imagination that warning letter volumes will jump in 2021. This is to some extent because the volume of warning letters dropped significantly over the past four years, and Boiani advised that all FDA-regulated industries will see more warning letters unless they are communicative with the agency about inspectional findings.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: B-Secur, Claronav Kolahi, RapidAI, Precision Biomonitoring, Precision Spine.
LONDON – The U.K has started the world’s first trial alternating an adenoviral vectored COVID-19 vaccine with one that delivers the virus spike protein instructions encoded in messenger RNA. The heterologous prime boost trial will recruit 820 participants into an eight-arm study comparing different combinations of the Astrazeneca plc/Oxford University and Pfizer Inc./Biontech SE vaccines, administered in a different order and at different intervals.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ardent Health Services, Ams, Axim Biotech, Bendcare, Botanisol Analytics, Casenet, Centene, Color, Colossal Contracting, Congenica, Decipher, Epredia, Extra Horizon, Fujifilm, Gabriel Precision Oncology, Gpm, Histosonics, Inspiremd, McGinley Orthopedics, Medline, Meridian Bioscience, Mobile Heartbeat, Netsmart, New England Biolabs, Ocean Insight, Quantumdx, Veeva, Veracyte, Vizient, Zyter.
Vaxart Inc. investors who stuck by company shares Feb. 3 had to swallow a bitter pill – watching shares of the oral vaccine developer (NASDAQ:VXRT) fall 57.8% to $9.85. Driving the trade in part was news that, during a phase I trial, neutralizing antibodies to SARS-CoV-2 were not detected in most of the five subjects given two doses of VXA-CoV2-1, its oral recombinant protein vaccine for the potential prevention of SARS-CoV-2 infection. Furthermore, the company concluded it was "unable to evaluate" a study of the candidate organized by Operation Warp Speed.
CAJICA, Colombia - Colombia approved two different phase II/III trials for COVID-19 vaccine candidates over the last week, advancing one candidate developed by Germany’s Curevac AG and another by China’s Clover Biopharmaceuticals Inc.
