Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Biolytical Laboratories, DNA Genotek, Pari Pharma, Salvia Bioelectronics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alveo Technologies, Biocartis Group, Coloplast, Decision Diagnostics, DJO Global, Endpoint Health, Geneprodx, Hutchinson Technology, Joline, Mir Scientific, Morton Comprehensive Health Services, Motus GI, Nine Continents Medical, Novarad, Ossdsign, Oxford Gene Technology, Remark Holdings, Resonetics, Sirakoss, Stryker, Wright Medical Group.
A multimillion dollar windfall for Icosavax Inc. will help allow the company to launch a COVID-19 vaccination program using its virus-like particle candidate (VLP), IVX-411, that displays the SAR-CoV-2 receptor-binding domain.
The dramatic increase in COVID-19 infections in Europe and the U.S., combined with information overload surrounding the lead up to the Nov. 3 contentious U.S. presidential election, was more than enough to send investors to the sidelines in October.
October brought another burgeoning swell of pandemic news with the U.S. granting its first FDA approval for a COVID-19 therapy, a promising vaccine candidate reaching full enrollment in phase III, and the stoppage of several trials due to safety signals.
LONDON – People infected with COVID-19 are likely to have T-cell immunity six months after contracting the virus, according to a U.K. study of 100 subjects who had an asymptomatic or mild to moderate infection.
DUBLIN – Kiadis Pharma BV has parlayed its €31.9 million (US$37.2 million) stock-based acquisition of Cytosen Therapeutics Inc. last year, which involved an initial outlay of just €14.5 million worth of shares, into a €308 million payday with Sanofi SA.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS announces testing agreements; TGA slaps two companies for violations.
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