Calling it a “landmark judgment,” the U.K.’s Competition and Markets Authority welcomed the Competition Appeal Tribunal’s Aug. 8 unanimous decision upholding an £84 million (US$107 million) fine levied against London-based Advanz Pharma Corp. for excessive drug pricing.
A logjam of clinical trial applications that has bult up at the U.K. Medicines and Healthcare products Agency (MHRA) is deterring companies from conducting studies in the U.K., according to the Bioindustry Association.
An estimated 10% to 20% of adolescents worldwide struggle with mental health issues. According to the CDC’s most recent Youth Risk Behavior Survey, nearly 60% of teen girls in the U.S. reported feeling sad every day for at least two weeks in the previous year and 22% of high school students considered taking their own lives. Yet despite these trends, the majority of mental health conditions in young people go undiagnosed and untreated.
The U.K. National Institute for Health and Care Excellence (NICE) is considering a coverage policy for stenting of the carotid arteries in asymptomatic patients, a change that could give these stents a significantly larger patient population in the U.K.
Results from a meta-analysis of magnetic resonance imaging (MRI)-guided adaptive radiation for prostate cancer by radiation oncologists from the Dana Farber Cancer Institute demonstrated the treatment reduces complications while comparing well to standard approaches. The study was published in Cancer.
Quantum Genomics SAS recently entered exclusive talks with Vistacare Medical SAS to create a leading player in complex wound management. “Vistacare Medical’s innovative contactless treatment technology, our financial backing and stock market listing, and the complementary nature of our two teams will enable us to accelerate the development of this new medical device on an international scale,” Jean-Philippe Milon, CEO of Quantum Genomics SAS, told BioWorld.
A research team from Leipzig University, the Max Planck Institute and Heidelberg University, all in Germany, devised a new segmentation algorithm for stroke lesions that improves upon previous methods. They used machine-learning models to effect CT image segmentation in the early stages of acute stroke. The research team published their findings on the fully convolutional graph network in July in the Journal of Medical Imaging.
The European Union and the U.S. have wrapped up a data privacy framework that covers broad swaths of both economies, including the transmission of clinical trial data across the Atlantic Ocean. Drug and device makers that want to make use of this framework and thus jettison the contractual clause to ensure data privacy may find compliance with this new framework much more efficient in the long run, but will have to do a lot of compliance work on the front end to achieve those efficiencies.
A research team from Leipzig University, the Max Planck Institute and Heidelberg University, all in Germany, devised a new segmentation algorithm for stroke lesions that improves upon previous methods. They used machine-learning models to effect CT image segmentation in the early stages of acute stroke. The research team published their findings on the fully convolutional graph network in July in the Journal of Medical Imaging.
Despite a newly signed $645 million commercialization deal with Neuraxpharm Group for multiple sclerosis drug Briumvi (ublituximab) in Europe, shares of TG Therapeutics Inc. (NASDAQ:TGTX) tanked by 49.3% on Aug. 1 due to a perceived miss in U.S. net sales for the anti-CD20 monoclonal antibody during its first full quarter on the U.S. market.
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