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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aspen Dental Management, B. Braun Melsungen, Baxter, Cape Biologix, Clearchoice, Diabeloop, Grifols, Inno-3B, Intralink-Spine, Masimo, Medicrea, Medtronic, Nuprobe, Plantform, Procept Biorobotics, Qiagen, Start Codon, Sun Capital Partners, Terumo.
Moderna Inc.’s phase III win with its COVID-19 vaccine candidate, mRNA-1273, lifted spirits while validating the Cambridge, Mass.-based firm’s platform, as Wall Street buzzed with comparisons between the prospects that have yielded late-stage data thus far.
LONDON – A second phase III trial of Johnson & Johnson’s adenoviral-vectored COVID-19 vaccine is starting in the U.K. this week, amid concerns the positive news from the Pfizer Inc./Biontech SE vaccine study will deter volunteers from coming forward to take part.
The latest global regulatory news, changes and updates affecting biopharma, including: Lawmakers protest latest 340B scheme; Groups make case for extending sequester moratorium; More $$ needed for global vaccine effort; Russia extends COVID-19 drug, device program.
A Polish/Dutch team of investigators has reported new insights into the structure of the SARS-CoV-2 genome that suggests it could be amenable to both small-molecule and oligonucleotide drugs.
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