The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA tweaks export final guidance per CARES Act; OIG: CMS should act to recover payments for device credits.
Lenzilumab, the lead candidate from Humanigen Inc., has taken two large steps forward with positive interim phase III data and some support from the federal government. That, along with an Asia-Pacific region licensing from earlier in the week, has the relatively small company successfully “punching above our weight,” the CEO told BioWorld.
DUBLIN – Canakinumab, an interleukin-1 beta (IL-1beta) inhibitor, has joined a growing list of immunomodulatory therapies that have failed to demonstrate efficacy in COVID-19. Novartis AG said that an interim analysis showed the drug did not meet the primary endpoint of clinical response.
The Coalition for Epidemic Preparedness Innovations (CEPI) said that it would fund a SARS-CoV-2 vaccine under development by Sichuan Clover Biopharmaceuticals Inc., of Chengdu, China.
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.
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