The U.S. FDA has granted breakthrough device designation to Salvia Bioelectronics BV for its implantable neurostimulation system to treat chronic migraine. The designation, which provides for priority review and consultation with the agency on product development, underscores the need for effective treatments for the costly and debilitating condition. According to a summary in a patent filing, the wireless system comprises a treatment pulse generator unit and an implantable electrode unit to provide neurostimulation therapy for headaches. Read More
PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. has linked up with Hong Kong-listed China Grand Pharmaceutical and Healthcare Holdings Ltd. (CGP) in a licensing and commercial deal worth AU$400 million (US$285 million) plus sales royalties. Read More
Nanobiotix SA ’s achieved promising early results in several clinical trials for its first-in-class radioenhancer. Despite the pandemic, trials in head and neck squamous cell cancer, hepatocellular carcinoma, pancreatic cancer, and rectal cancer remain on track, the Cambridge, Mass., and Paris-based company reported at ASTRO 2020. Read More
As might be expected, device makers have a lot of nice things to say about a recent proposal by the U.S. Centers for Medicare & Medicaid Services (CMS) to automatically cover technologies designated as breakthrough devices by the FDA. However, two trade associations and the Medicare Payment Advisory Commission (MedPAC) all expressed serious misgivings about a proposal to define the term “reasonable and necessary” as possibly contingent on private payer coverage. Read More
HONG KONG – Aprinoia Therapeutics Inc. is poised to start phase III clinical trials for its positron emission tomography (PET) imaging tracer 18F-APN-1607 in China, after receiving the green light from the National Medical Products Administration. Read More
To say a lot is riding on the Nov. 3 presidential and congressional election in the U.S. would be an understatement, as the outcome could impact drug pricing, patent reform, research spending and pandemic response and preparedness. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA announces recall of discontinued Medtronic catheter. Read More
Med-tech firms raising money in public or private financings, including: Fountain Healthcare Partners, Kyowa Kirin, Massive Bio, Nurami Medical. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Immunovia, Seaspine, Strata Skin Sciences. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alveo Technologies, Biocartis Group, Coloplast, Decision Diagnostics, DJO Global, Endpoint Health, Geneprodx, Hutchinson Technology, Joline, Mir Scientific, Morton Comprehensive Health Services, Motus GI, Nine Continents Medical, Novarad, Ossdsign, Oxford Gene Technology, Remark Holdings, Resonetics, Sirakoss, Stryker, Wright Medical Group. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Biolytical Laboratories, DNA Genotek, Pari Pharma, Salvia Bioelectronics. Read More
Keeping you up to date on recent developments in oncology, including: Microfluidic provides model for testing therapies on pancreatic ductal adenocarcinoma; Cutting off AML’s metabolic escape route; NGF: PDAC’s VEGF?; Revving up cisplatin by targeting Rev7. Read More
