SALT LAKE CITY–(BUSINESS WIRE)– Clinical Innovations, one of the largest medical device companies dedicated to labor and delivery and neonatal intensive care, has signed a definitive agreement to be acquired by LABORIE Medical Technologies for an enterprise value of $525M.…
AI-based heart failure screening from Eko, Mayo Clinic earns FDA breakthrough nod
Dive Brief: Digital health company Eko said Wednesday it received FDA’s breakthrough device designation for priority review of the company’s algorithm to detect heart failure with a specialized stethoscope during a routine physical exam. The algorithm helps identify reduced left…
Tandem wins FDA go-ahead for 1st interoperable, automated insulin dosing software
Dive Brief: FDA on Friday authorized the third and final type of diabetes management technology necessary for a fully interoperable, automated insulin dosing system. The De Novo clearance went to Tandem Diabetes’ Control-IQ glycemic control algorithm, which is designed to in…
George Clinical and Guangdong Provincial People’s Hospital to Collaborate in Clinical Research
BEIJING, December 19, 2019 – George Clinical, a global scientifically-backed clinical research organization (CRO), and Guangdong Provincial People’s Hospital (GDPH) have executed a memorandum of understanding (MoU) laying out broad collaboration in the area of clinical research in China. The…
Takeda Strikes Potential $1 Billion Oncology Deal with Turnstone
One day after Takeda and Cerevance teamed up to tackle diseases of the gastrointestinal tract, the company forged a collaboration worth up to $1 billion with Turnstone Biologics to tackle a number of cancer indications using that company’s vaccinia virus…
How Regeneron, DNAnexus Sequenced Half A Million UK Biobank Samples
In 2006, the UK Biobank (UKB)—a national and internationally-available long-term biobank funded by the Wellcome Trust and the UK Medical Research Council (MRC)—began an ambitious project in which they recruited 500,000 people between the ages of 40-69 to create a…
Astellas and Seattle Genetics Win Accelerated Approval for Bladder Cancer Drug
Astellas Pharma and Seattle Genetics received an early present from the U.S. Food and Drug Administration (FDA) – accelerated approval for Padcev, a first-of-its-kind treatment for adult patients with metastatic urothelial bladder cancer. Late Wednesday, the FDA granted the two companies approval…
Will Wearable Device Become First-line Treatment For Migraines?
Israeli biomedical technology company Theranica is intent on making its new-to-market remote electrical neuromodulation wearable device a first-line treatment for migraines of every type. As of early December, early adopters of Nerivio included 2,176 patients at nearly 150 headache clinics…
FDA Approves Pfizer’s Extended Release Xeljanz for Ulcerative Colitis
Pfizer’s Xeljanz (tofacitinib) won approval from the U.S. Food and Drug Administration (FDA)as a treatment for patients with moderately to severely active ulcerative colitis (UC), after an inadequate response or intolerance to tumor necrosis factor inhibitor (TNFi) blockers. The FDA…
GSK leanest with R&D spend in big pharma – but gets bang for its buck
GlaxoSmithKline’s CEO Emma Walmsley has made great play of her company’s new approach to R&D under the leadership of its guru Hal Barron. After taking over in 2017 Walmsley is looking for a new direction in research focused on areas…
