PARIS – The French Association of CROs (AFCROs) has published the third edition of its survey of clinical research in France. This tool is intended to provide an overview of clinical research in that country, along with any recent developments.
LONDON - The director general of the World Health Organization has given a dignified and measured response to President Donald Trump’s decision to halt U.S. funding of WHO, pending a review of its handling of the coronavirus pandemic.
PARIS – Medical gases specialists Air Liquide SA, of Paris, along with Peugeot SA, Schneider Electric SE and Valeo SA have joined together in a consortium to manufacture ventilators in a time when there is a critical shortage.
Abbott Laboratories, of Abbott Park, Ill., reported that its Triclip transcatheter tricuspid valve repair system has received the CE mark. The device is a nonsurgical treatment for people with tricuspid regurgitation (TR), and, according to the company, it is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available. The Triclip is delivered to the heart through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood.
DUBLIN – The EMA has activated a COVID-19 task force to coordinate and accelerate the European regulatory response to the pandemic. The task force is intended to take a lead role in shaping the development, authorization and post-approval surveillance of drugs and vaccines for treating or preventing COVID-19 infection.
PERTH, Australia – Sydney-based molecular diagnostics company Genetic Signatures Ltd. received the CE mark for its 3base Easyscreen SARS-CoV-2 detection kit, clearing the way for marketing across the EU.
PERTH, Australia – The British Standards Institute (BSI) granted Sydney-based Oncosil Medical Ltd. European CE marking approval for its brachytherapy device to treat locally advanced pancreatic cancer in combination with chemotherapy, clearing the way for marketing in both the EU and the U.K. BSI also granted the Oncosil device breakthrough therapy designation.
PARIS – Europe has turned into the epicenter of the coronavirus pandemic, seeing more than 50% of the cases observed worldwide. In fact, whereas the COVID-19 pandemic has begun declining in China where it originated, there are 400,000 cases of coronavirus worldwide, including more than 200,000 infected by SARS-CoV-2 in the 55 sovereign states in continental Europe, where they are mourning more than 18,000 deaths.
Citing the rapidly changing situation related to COVID-19, Watford, U.K.-based Smith+Nephew plc said it is withdrawing its 2020 outlook. It highlighted COVID-19’s spread beyond China, as well as the slow pace of recovery for elective procedures in that country.
LONDON – The European Commission (EU) is pulling the plug on implementation of the Medical Devices Directive (MDR) on May 26, to free up resources and expertise as countries across Europe struggle to deal with the COVID-19 crisis.