The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE reviews Dexcom’s G6; Ortho claims EUA for antigen test with 100% sensitivity.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Astellas, Basilea, Gosun, Bristol Myers Squibb, Lipocine, Sarepta, Sedor, Senhwa.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affimed, Artiva, Astrazeneca, Felix Bio, ICER, Kannalife, OM Pharma, Roche, TFF, Vaccibody, Vir.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Assembly, Boehringer Ingelheim, Equillium, Homology, Humanigen, Janssen, Novartis, Pfizer, Puma, Seres, Viela.
LONDON – The Danish government has ordered a mass cull of 15 million mink following evidence the animals are harboring a variant of SARS-CoV-2 with mutations in the spike protein through which the virus infects human cells.
The COVID-19 pandemic has affected the U.S. FDA on the postmarket side as well as on the premarket side, but the focus of pandemic-driven warning letters has shifted over time. Amanda Johnston, senior attorney at Gardner Law of Stillwater, Minn., said on a Nov. 5 webinar the FDA’s emphasis lately has been closer to the agency’s traditional enforcement considerations after an initial wave of warnings dealing with flatly fraudulent products.
Becton, Dickinson and Co. (BD) reported good news Thursday, as it saw quarterly revenues of $4.784 billion for its fourth fiscal quarter, an increase of 4.4% over the prior-year period. Of note, the company’s life sciences segment saw worldwide revenues of $1.488 billion, representing an increase of 31.2% over the prior-year period as reported, or 31.4% on a currency-neutral basis.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3D Systems, Avinger, Eurofins Scientific, Oxford Immunotec, Pear Therapeutics, Sectra, Veracyte.
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