The U.S. Federal Trade Commission (FTC) issued a final order in connection with the proposed reacquisition of Grail Inc. by Illumina Inc., in an action that might seem to finally conclude a matter that has stretched over several years. However, the FTC acknowledged that Illumina has 60 days to petition the order, which Illumina said it intends to do in conjunction with an effort to overturn a similarly adverse outcome in the EU. Read More
Masimo Corp.’s Opioid Halo, an opioid overdose prevention and alert system, was granted de novo status by the U.S. FDA. The device detects opioid-induced respiratory depression, the primary cause of opioid deaths. The de novo authorizes the company to make Halo available over the counter and by prescription for use on individuals aged 15 and up. Read More
France is tightening access to the reimbursed health care market for digital medical devices. The national Digital Healthcare Agency (ANS) reported that a standard interoperability and safety system for digital medical devices is coming into force. Read More
Radiopharmaceuticals have been used for a long time for diagnostics, but radiopharma therapies are entering a new era in which they are becoming widely accepted as a key tool in the oncology armamentarium potentially providing patients with a big bump in efficacy with fewer side effects and less damage to healthy tissue. In this eight-part series, BioWorld takes a deep dive into this new treatment modality to explore what the new uses or alternatives are and what the future of radiopharmaceutical therapy might look like. Part one sets the stage and outlines the beginnings of the industry and some of the challenges drugmakers will need to overcome. The series takes a closer look at the different radiopharmaceutical moieties, the science behind them, the patient journey, the therapies in the pipeline, the regulatory landscape, and the supply chain vulnerabilities. Read More
The big idea behind radiopharmaceuticals is taking the hallmarks of two cancer therapies – radiology and chemotherapy – and merging them, and this is what makes the technology a disrupter. Read More
Global interest in radiopharmaceuticals is growing, and some big deals in the space have sparked interest in the last few years. Novartis AG has spent about $6 billion in acquisitions and is seen as the global leader. Read More
Philips RS North America LLC, formerly known as Respironics Inc., has agreed to pay more than $24 million to settle allegations that the company violated the False Claims Act in relation to CPAP equipment, another hit on the company which has been dealing with a stream of FDA recalls for these products. The allegations include that Philips RS provided durable medical equipment suppliers physician prescribing data to help these suppliers market their inventory, an unusual vector for violation of the FCA. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Celularity, Davita, Greenbrook TMS, Labcorp, Lucid Diagnostics, Medtronic, Semler Scientific. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Masimo. Read More
