More women in England and Wales are to be offered a test to better determine the causes of heavy menstrual bleeding, on updated guidelines from the National Institute for Health and Care Excellence.
The FDA has slapped a clinical hold on a combo therapy using Advaxis’$ADXS axalimogene filolisbac along with AstraZeneca’s approved PD-L1 Imfinzi following the death of a patient in their Phase I/II trial.
Janssen leads in cardiovascular innovation using real-world data to detect asymptomatic atrial fibrillation Home-based clinical study underscores the game-changing role of digital technology in future of health care
On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and Australia under its Medical Device Good Manufacturing Practice.
An AliveCor algorithm has identified people with high potassium levels from electrocardiogram (ECG) data. Limited prospective clinical testing suggests pairing the algorithm with AliveCor’s smartphone and Apple Watch-based ECGs could enable the remote, noninvasive monitoring of potassium levels.
Science 37, a trailblazing company focused on “site-less” clinical trials, announced today a strategic alliance with Novartis that will support the development of its new decentralized clinical trial (DCT) offerings. This three-year commitment will enable a more extensive portfolio of trials powered by the Network Oriented Research Assistant (NORA®), Science 37’s proprietary technology platform that enables patients to participate in clinical research regardless of their geographical location using mobile devices and telemedicine services.
Big Pharma Sanofi and German CRO-biotech drug discovery hybrid Evotec are penning a deal that will see Sanofi license out a host of infectious disease assets to the biotech, with 100 staffers also moving into its R&D engine.
GSK touted phase 3 data of its quadrivalent flu vaccine Fluarix Tetra. As a severe flu season continues to unfold in the U.S., GlaxoSmithKline is touting phase 3 study data showing its Fluarix Tetra can protect young children who are among the most vulnerable to the virus.
The U.S. Food and Drug Administration expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.
Medtec China 2018 is taking place on September 26–28 in Shanghai China. This year the scale of the show will grow by 10% reaching a new height since 2015; it is now at a scale making utilization of an entire hall possible to hold the show.
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