Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dascena, Labcorp, OralDNA Labs.
Keeping you up to date on recent developments in neurology, including: Social isolation increases anxiety and asymmetry in brain atrophy in AD; Researchers test brain stimulation in zero gravity; Angiotensin inhibitors for AD prevention.
Genetron Holdings Ltd., a Beijing-based precision oncology company, has gained breakthrough device designation status from the U.S. FDA for its blood-based, next-generation sequencing test for the early detection of hepatocellular carcinoma (HCC). The test, called HCCscreen, is intended for individuals at high risk for HCC due to chronic hepatitis B virus infection or liver cirrhosis.
Alucent Biomedical Inc., which is developing a restorative therapy for peripheral artery disease (PAD), completed a $35 million series B financing led by a multinational strategic investor. The funds will be used to complete clinical studies of the Alucent Natural Vascular Scaffolding (AlucentNVS) vessel restoration system with photoactivated linking, the company’s first product.