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
News on diagnostic and therapeutic innovations and regulatory science
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.
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.
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.
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.
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.
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.
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.
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.
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.
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