The implementation date for the European Union’s In Vitro Diagnostic Regulation (IVDR) is a mere 16 months away, although there is widespread interest in a delayed implementation date. Nonetheless, Warren Jameson, principal regulatory consultant for North American Science Associates (NAMSA) of Toledo, Ohio, urged test makers to conduct a gap analysis of the conformity of their currently marketed tests to the new regulations because a large percentage of the underlying dossiers would not pass muster under the terms of the new regulatory regime.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Canon Medical Systems, Covaxx, Lumiradx, Retia Medical, Zimmer Biomet.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aiforia, Atc Alert, Berkshire Biomedical, Biotheranostics, Brain Scientific, Bruker, Cairnsurgical, Canadian Hospital Specialties, Carenity, Cerba Research, Echosens, Electrocore, Erba Mannheim, Fortress Medical Systems, Helix, Imbiotechnologies, Inivata, Natera, Numares, Orasure, Pathan, Polarityte, Premier Medical Laboratory Services, Qiagen, Thomas Scientific, Viveve, Xclinical.
Keeping you up to date on recent developments in diagnostics, including: Increasing COVID-19 detection through secondary distribution of self-tests; COVID-19 and breath analysis; Saving lives from colorectal cancer; New classification scheme for glioblastomas.
Antibody development for treating COVID-19 continues producing positive results, the latest being from Eli Lilly and Co.’s bamlanivimab (LY-CoV-555), which reduced nursing home residents’ risk of contracting symptomatic COVID-19 by 80%, according to new data from its phase III Blaze-2 study.
One of the side effects of COVID-19 is the acceleration of a shift in health care delivery that is changing how drug and device companies market their products to doctors. There’s no going back to the commercial model where having a sales rep call on a doctor was the way to market a product, Rita Numerof, CEO and co-founder of Numerof & Associates, said during a Jan. 21 webinar on the impact the pandemic has had on drug and device detailing.
With worrisome COVID-19 variants cropping up, developers including the likes of Gritstone Oncology Inc. and Vir Biotechnology Inc. continue their efforts to invent new vaccines that may get around the drawbacks of existing shots if they turn up.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Addex, Eubiologics, J&J, Medolife, Menarini, RDIF, Roche, Turn, Ultragenyx.
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