Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hyperfine, Thermo Fisher.
A cocktail of monoclonal neutralizing antibodies developed by Brii Biosciences Ltd. has become “the first locally-discovered and approved SARS-CoV-2 target-specific treatment in China, through a randomized, double-blind and placebo-controlled trial,” Rogers Luo, president and general manager of greater China at the company, told BioWorld. The NMPA approved a combination of Brii’s amubarvimab and romlusevimab as a treatment for both adults and pediatric patients, ages 12 to 17, with mild and “normal type” COVID-19 at high risk for progression to severe disease, including hospitalization or death.
The Russian Federation is making progress in building its drug supply system and increasing access to medicines and medical devices. In a Dec. 7 update on the progress being made, Minister of Health Mikhail Murashko highlighted the work of the Circle of Kindness fund, efforts to ensure the availability of vaccines and other drugs throughout the federation, and the launch of a labeling system to promote the timely identification of uncertified and counterfeit drugs.
U.S. President Joe Biden has yet to nominate a new director to helm the National Institutes of Health (NIH) when Francis Collins steps down next week, but in the interim, Lawrence Tabak, the principal deputy director at the agency, will serve as the acting director beginning Dec. 20.
Makers of vitro diagnostics (IVDs) are facing several significant challenges in the next few years, thanks to existing and impending revisions to a number of regulatory frameworks. There are other considerations that are adding to the headwinds, such as a poor patent protection environment in the U.S., the net effect of which is to make life unusually miserable for developers of these tests.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aytu, Bioinvent, Biontech, Cybin, Cytodyn, Daré, Moderna, Neurop, Nuvation, Pfizer, Saol, Supernus.
Daré Bioscience Inc.’s investors will have to wait a while for details regarding a commercialization partnership centered on Xaciato (2% clindamycin phosphate gel, formerly known as DARE-BV1) as a single-dose treatment of bacterial vaginosis (BV) in females 12 years of age and older. Approved Dec. 7, Xaciato is expected to launch next year.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Achiko, Foundation Medicine, Philips.
Shanghai Henlius Biotech Inc.’s self-developed Hanbeitai (bevacizumab biosimilar) has received marketing approval from China’s NMPA. It was approved for the treatment of metastatic colorectal cancer and unresectable, locally advanced, recurrent, or metastatic non-squamous non-small-cell lung cancer.
There is now more clarity on the Omicron variant of SARS-CoV-2, as serum antibodies produced by three doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine have been shown to neutralize it. The data arrived a day after Glaxosmithkline plc and Vir Biotechnology Inc. said the monoclonal antibody sotrovimab retains activity against key mutations of the Omicron variant, including those found in sotrovimab’s binding site.