The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed urges administration to communicate on DPA; FDA posts third-party report for Q1, FY 2021.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Fluidigm.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alkido, Amarin, Aurinia, Biontech, Continuous, Edding, Eli Lilly, Esperion, Evgen, GSK, Humanigen, ICER, Innocan, Microba, Pfizer, Sartorius Stedim, Vaxess.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aslan, Birchbiomed, Immutep, Nanoform, Regeneron, Sanofi, Senhwa, Windtree.
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.
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