Illumina Inc.’s acquisition of cancer diagnostic specialist Grail Inc. is on go in a $7.1 billion transaction that is structured so that it can be unwound with limited impact on Illumina. However, a number of regulatory entities are closely scrutinizing the deal for a potential regulatory challenge, a fact of life that shaved nearly 10% off the value of the company’s shares in early Aug. 19 trading, and which could ultimately scuttle the transaction altogether. Read More
Jorge Ulloa of Hancock Jaffe Laboratories Inc. presented positive results from a first-in-human trial of implantation with its Venovalve device at the Society for Vascular Surgery annual meeting in San Diego. Two years following surgery, outcomes included more than 60% improvements in reflux and disease manifestations and 93% decrease in pain in patients with chronic venous insufficiency with no safety issues or venous ulcer recurrences. Read More
An update from China’s NMPA clarifying registration requirements and classification methods for drug-device combination products has been welcomed by industry as the regulator seeks to keep pace with fast-moving developments in the sector. Read More
PARIS – Magnetic fields can be used to stimulate blood vessel growth, according to a new study published in Science and Technology of Advanced Materials. The discovery, by researchers from the University of Lisbon in Portugal, could lead to new treatments for cancer and help regenerate tissues that have lost their blood supply. Read More
Visus Therapeutics Inc. has expanded its ophthalmic drug portfolio, in-licensing investigational therapies for glaucoma and age-related macular degeneration from Cella Therapeutics LLC, which will be developed by Finland’s Delsitech Ltd. using its extended-release depot technology. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amgen, Amoy Diagnostics, Empower, Guided Therapeutics, Inovalon, Shandong Yaohua Medical Instrument. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neoteryx, Roche. Read More
