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.

Biopharma industry leaders in China who were the first to experience the chaos of the COVID-19 pandemic shared their thoughts during a closing plenary session of the virtual Bio-Europe Spring 2020 meeting.

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.

The five-day Bio-Europe Spring 2020 conference, possibly the first ever life sciences partnering event staged in an all-virtual format, ended on Friday, March 27, with high hopes that the industry would return to face-to-face interactions next year in Barcelona.

Biopharma industry leaders in China who were the first to experience the chaos of the COVID-19 pandemic shared their thoughts during a closing plenary session of the virtual Bio-Europe Spring 2020 meeting.

DUBLIN – Novartis AG, Bristol Myers Squibb Co. and Sanofi SA were among firms that secured positive opinions from EMA’s Committee for Medicinal Products for Human Use (CHMP) on marketing authorization applications for new therapies, which will progress to formal approvals 67 days from now. Because of the COVID-19 pandemic, the committee’s March meeting was held virtually.

Leuven, Belgium-based Midiagnostics NV, which is looking to bring miniaturized, rapid, blood-based tests with built-in connectivity to both patients and clinicians, reported the completion of a €14 million (US$15.4 million) investment round. The company intends to use the funds to speed the development of its nanofluidic processor on a chip and prepare it for industrial-scale manufacturing.

DUBLIN – Bio-Europe Spring’s virtual panel on the partnering dynamic between big pharma and microbiome-focused biotech firms was essentially an in-house webinar hosted by Seventure Partners, a Paris-based venture capital fund that has led the way in investing in microbiome-related therapeutics, diagnostics and other products.