Ixlayer Inc. partnered with CVS Health Corp. to streamline lab testing, lower costs and provide actionable steps for patients through a new at-home testing service. Starting with vitamin D levels, Lyme disease, sexually transmitted infections and thyroid function, the collaboration will put a wide range of common lab tests on the pharmacy giant’s shelves and online service for consumers to buy without a prescription or doctor’s visit and at a reduced cost compared to conventional testing channels. Read More
Just days after taking the helm of Royal Philips NV, CEO Roy Jakobs told shareholders that the company plans to “immediately reduce our workforce by around 4,000 roles globally” as a result of multiple challenges that contributed to poorer than expected third quarter results. The company posted a net loss for the quarter, missing consensus, which it attributed to continuing supply chain issues and the deteriorating economic environment. Read More
Medicare coverage of breakthrough medical devices is in its fourth iteration under the rubric of Transitional Coverage of Emerging Technologies (TCET) and two managers at the Centers for Medicare & Medicaid Services recently penned an op-ed in a leading medical journal about the TCET program, which generated at least as many questions as answers.
Jiangsu Cowin Biotech Co. Ltd. has raised ¥1.14 billion (US$156 million) in a listing on the Shanghai STAR Market. Its shares opened at ¥42.96 apiece, plunged over 13% by the middle of the day but closed at ¥43.62 on the first trading day on Oct. 25. Read More
Enhanc3D Genomics Ltd. has raised £10 million (US$11.3 million) in a series A round to advance development of its Genlink3D technology for directly linking gene regulators in non-coding DNA to their target protein coding genes. Read More
Device makers often need the assistance of physicians to aid in device design and development, but this is a practice that comes with some legal hazards. A session held here in Boston on enforcement in the U.S. made clear that manufacturers must exercise caution in these consulting arrangements, such as documenting the need for outside help with the device, lest the manufacturer end up with a hefty, multimillion-dollar fine imposed by U.S. enforcement agencies. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, Glympse Bio, Notal Vision, Preludedx. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adagio, Carmat, Neuronetics, Neurovative, Neurox, Nihon Medi-Physics, Padula Rehabilitation, Sensoria, V-Wave. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Astrazeneca, Biontech, Carsgen, GSK, Kira, Moderna, Novavax, Pfizer, Roche, Telix, Zhiyu. Read More
