US, Chinese teams to collaborate on coronavirus research | Fist Assist vein compression device gets CE mark | COVID-19 outbreak hinders FDA inspections in China
February 27, 2020
DIA Global SmartBrief
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American investigators from Harvard University and a team of Chinese researchers from China's Guangzhou Institute of Respiratory Health will collaborate, backed by $115 million in funding, to develop preventive and curative treatments for the new coronavirus spreading rapidly across the globe. The Chinese team will be led by Dr. Zhong Nanshan, who was credited with the discovery of the SARS coronavirus in 2003.
Full Story: Genetic Engineering & Biotechnology News (2/24) 
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European regulators has granted CE mark approval to Fist Assist Devices' noninvasive intermittent vein compression device for phlebotomy and hemodialysis fistula development procedures, and for fistula vein dilation for hemodialysis in patients with end-stage renal disease. The company has introduced the device to the European market.
Full Story: MassDevice (Boston) (2/24) 
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Asia Pacific
The US State Department's travel advisory regarding the coronavirus outbreak is preventing the FDA from inspecting medical device plants in China. Until the advisory is lifted, the agency plans to employ other means of monitoring incoming products from China, such as import screening, sampling and import alert tools and relying on information from foreign governments.
Full Story: MassDevice (Boston) (2/25) 
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North America
The FDA said no pharmaceutical firms have reported a shortage of any drugs as result of the coronavirus outbreak, but the agency is closely monitoring 20 medications that are made in China or rely solely on active pharmaceutical ingredients from China. The agency also said it has reminded more than 180 manufacturers to notify the FDA of any potential supply chain disruptions.
Full Story: Regulatory Focus (2/25) 
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An analysis of data from 26 observational studies found acid-suppression drugs may increase the risk of intestinal colonization of Enterobacterales and vancomycin-resistant enterococci, researchers reported in JAMA Internal Medicine. Researchers said the data may offer insight into the appropriate use of acid suppressants.
Full Story: Healio (free registration)/Gastroenterology (2/24) 
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The FDA has initiated the review for Roche's breast cancer combo regimen consisting of Herceptin and Perjeta. A decision is expected from the agency by Oct. 18.
Full Story: PMLive (UK) (2/25) 
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An accelerated program was launched by British diagnostics firm Mologic and the Institut Pasteur de Dakar for the development of a high-performance, low-cost rapid diagnostic assay for the early detection of Ebola virus infections. Three prototypes are being validated by staff before a trial is initiated in the Democratic Republic of the Congo by next month in cooperation with the DRC's National Institute of Biomedical Research.
Full Story: 360Dx (tiered subscription model) (2/25) 
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Novartis announced that the FDA has accepted its supplemental biologics license application, while the European Medicines Agency accepted its marketing authorization application for its candidate ofatumumab, a fully human anti-CD20 monoclonal antibody developed to treat adult patients with relapsing forms of multiple sclerosis. Ofatumumab's regulatory approval is expected in the US in June and the second quarter of 2021 in Europe.
Full Story: PharmaTimes online (UK) (2/25) 
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Results from a study that evaluated the responses and outcomes from 22 patients with chronic hepatitis C virus genotype 4 to the combination therapy of sofosbuvir and ledipasvir showed that the regimen was safe and could be tolerated by patients aged three to six years old. Details of the study were published in the journal Liver International.
Full Story: Medscape (free registration) (2/25) 
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DIA News
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The DIA 2020 Global Annual Meeting (Jun. 14-18 in Washington, DC) is not just about attending sessions, but also making connections. Inside and outside of session rooms you'll have the exclusive opportunity to engage with life science experts from all corners of the globe -- more than 55 countries are represented each year. Sharing insights with other attendees is how solutions are formed to tackle today's greatest challenges. We're excited to begin sharing the DIA 2020 program agenda with you. With 250+ sessions spanning 13 educational tracks, the possibilities for learning and networking are endless. Start browsing all of the program offerings and sessions available to date and begin to plan out your days in historic DC. Secure your seat today.
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I don't have a feeling of inferiority. Never had. I'm as good as anybody, but no better.
Katherine Johnson,
mathematician, NASA scientist, Presidential Medal of Freedom recipient
February is Black History Month
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