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.
Abbott Laboratories Inc. announced U.S. FDA clearance for its next-generation Freestyle Libre 3 continuous glucose monitor (CGM) system for people aged 4 years and older with diabetes. Accuracy of the sensor was evaluated in a non-randomized, multicenter, single-arm study with 100 people on intensive insulin therapy (95, aged 6 years and older). Results from the pivotal trial were released May 31, showing it is the first CGM to demonstrate a mean absolute relative difference (MARD) below 8%, indicating it will be one of the most accurate sensors on the market.
More than 1.6 million spinal procedures are performed in the U.S. each year and between 10% and 30% of them fail to achieve their objective, indicating that the field has abundant room for improvement. Both equipment manufacturers and the FDA hope to improve spinal surgery success rates as seen in two clearances granted on May 31.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Embody, Si-Bone, Stryker, Volition.
About $1.7 trillion in securities of China-based issuers listed on U.S. exchanges could face trading prohibitions in as little as two years, Y.J. Fischer, director of the U.S. SEC’s Office of International Affairs, warned during remarks at the May 24 annual meeting of the International Council of Securities Associations.
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
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