Myriad Genetics Inc. is launching a new suite of genetic tests designed for personalizing chemotherapy treatment. The Precise oncology offering includes Myriad’s precise tumor molecular profile test and two companion diagnostic tests, Mychoice CDx and Bracanalysis CDx. The company said the combination of germline, somatic and companion testing aims to maximize information for oncologists as they assign individual treatment plans. Results from each test are gathered as a single report accessed on an online portal.
Hansoh Pharmaceutical Group Co. Ltd. has won a green light for inebilizumab, approved by China’s NMPA for the treatment of adults with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive. The decision marked Hansoh’s first biologic approval.
The U.S. Securities and Exchange Commission (SEC) recently issued a provisional list of five U.S.-listed Chinese companies that reportedly failed to submit necessary accounting reports required under Holding Foreign Companies Accountable Act. The list included three biopharmas: Beigene Ltd., Hutchmed Ltd., and Zai Lab Ltd.
The bipartisan PREVENT Pandemics Act, which seeks to put into U.S. law many of the lessons learned from the COVID-19 pandemic, marked its first milestone March 15, with the Senate Health, Education, Labor and Pensions (HELP) Committee sending it to the full Senate with a do-pass recommendation on a 20-2 vote.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Corium, Cstone, Incyte, Phathom, Sifi, Sinomab, Xortx.
The FDA issued a rare 518(a) Notification Order to Royal Philips NV last week that requires the company to take more aggressive measures to notify patients, physicians and distributors about the June 2021 class I recall of its continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) systems. The recall stemmed from health risks posed by the deterioration of the polyester-based polyurethane (PE-PUR) noise reducing foam in the equipment.
Neuton Health Co. Ltd.’s virtual reality (VR)-based therapy for acrophobia has been given class II medical device approval from China’s NMPA. The VR therapy, known as Specific Fear Rehabilitation Training Software, was co-developed with the Shanghai Mental Health Center. The digital therapy company said it is the first VR device of its kind for a specific phobia approved in the world.
Norwegian diagnostics company Cardinor AS landed a CE mark for its Secretoneurin (SN) ELISA (enzyme-linked immunosorbent assay). The blood-based test detects SN, a small 33-amino acid neuropeptide produced by neuroendocrine and heart muscle cells. Studies have shown the biomarker is a predictor of mortality in major patient cohorts, including ventricular arrhythmia, acute heart failure, acute respiratory failure patients with cardiovascular disease (CVD) and severe sepsis.
The C-suite at Dexcom Inc. is breathing easy with the company having snagged CE marking for its latest continuous glucose monitoring (CGM) system, the G7, less than two weeks after receiving FDA breakthrough device designation for its CGM for hospital use. “This all-new platform offers an incredibly powerful CGM that is simple to use, providing our users with insightful glucose data on one screen that helps them spend less time managing diabetes and more time doing the things they love. Dexcom G7 takes everything people love about G6 and makes it even better,” said Dexcom CEO Kevin Sayer.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dexcom, Fresenius Kabi, Guardant Health, Myriad Genetics, Shoulder Innovations.
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