The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA posts guidance agenda for FY 2021; Third-party 510(k) review report posted; NIOSH testing flunks more imported filter masks; OIG says Cedars-Sinai billed for non-compliant bariatric surgeries.
The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Anges, Aslan, Beyond Air, Er-kim, ICER, Macrogenics, Omeros, Takeda.
Although the volume of med-tech deals and mergers and acquisitions in 2020 rival each of the last two years, the level of disclosed values has fallen far short of 2019 in both instances.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Added Value Business and Marketing Solutions, Boehringer Ingelheim, Bioaffinity, Biovo Technologies, Blackstone Medical Services, Cardiac Safety Research Consortium, Fujifilm Medical Systems U.S.A., IDbyDNA , Illumina, IT-IS International, Jaya Unggul Gemilang, Konica Minolta, Mevion, Novacyt, Nupaf, Olim Het, Philips, Precision Pathology Services, Scriptsender, Smiths Medical, Summit, Trekstor, Victory Square, Volpara Solutions.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Federal Circuit declines to overturn lower court ruling for Medtronic; FDA stands pat on biotin interference threshold in final guidance; CMS adds to telehealth list.
“It’s coming. We know it’s coming.” That was Nevan Krogan’s blunt reminder that SARS-CoV-2 is not the first virus to wreak temporary havoc on humanity, nor will it be the last.
LONDON – COVID-19 research is generating a wealth of data every day, but it is coming from many and disparate sources, making it difficult to assess its quality, dovetail datasets together and decide how to apply it.
DUBLIN – The Lancet Infectious Diseases has published the first clinical data on BBIBP-CorV, an inactivated whole virus vaccine directed against SARS-CoV-2. The early stage phase I/II study tested the Chinese-developed vaccine in 540 healthy volunteers, including 96 older participants. All vaccine recipients seroconverted and the adverse event profile was mild.
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