Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardio Flow, Lumiradx, Net Health.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Codagenix, Eagle, Foresee, Hutchmed, Kashiv, Kymera, Mezzion, Midatech, Neuronascent, Roche, Sanofi, Swedish Orphan, Teon, TG, UCB, VBI.
The U.S. Cybersecurity & Infrastructure Security Agency (CISA) said the Synapsys microbiology informatics software platform has an access vulnerability due to an inadequate session expiration mechanism. Becton, Dickinson & Co. (BD), the publisher of the Synapsys system, said three versions of the software are vulnerable, but this vulnerability can be exploited only by those with direct access to the workstations, making this a lower risk than some other recently reported vulnerabilities.
Pivotal in killing the Biden administration’s Build Back Better budget legislation, Sen. Joe Manchin (D-W.Va.) is now working to revive parts of it, including the provision that would require Medicare to directly negotiate prescription drug prices.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Burning Rock, Genetron, Novacyte, Royal Biologics, Saneso, Stratipath.
The FDA announced a class I recall of the Dragonfly Opstar imaging catheter by Abbott Vascular, of Santa Clara, Calif., due to the loosening of a band marker that may lead to separation from the catheter. The agency said two instances in which the marker has separated from the catheter have been reported, with another three incidents of loosening without separation.
China has granted a green light for Glaxosmithkline plc’s human papillomavirus (HPV) vaccine, Cervarix, for girls ages 9 to 14. The HPV bivalent vaccine is used against types 16 and 18 in a two-dose course to prevent cervical cancer. It’s the first imported two-dose HPV vaccine for the age group to be approved in China, the company said. A three-dose schedule of Cervarix won Chinese approval in July 2016 for girls and women ages 9 to 25. To date, the two-dose regimen has been approved in about 100 global markets.
China’s National Medical Products Administration (NMPA) released a new draft amendment to its Drug Administration Law (DAL) that introduces some important changes to the regulatory framework and is aimed at codifying initiatives implemented in the current DAL, such as patent linkage and regulatory data protection.
Volitionrx Ltd. won the CE mark for its Nu.Q NETs test for the detection, evaluation and management of NETosis, a type of cell death characterized by the release of neutrophil extracellular traps, or NETs. The test – the first biomarker approved for the measurement of NETs for patient management – will soon be available for clinical use across the E.U.’s 27 member states.
RSS
