flanders.bio is a dynamic, member driven organisation with currently more than 350 members from Belgium and abroad. We help our members to create value by organising Networking and Training Activities, supporting Internationalisation, providing Services and building Expertise. flanders.bio and its members want to be the proud advocates of a reputable global-impact ecosystem in life sciences.
News from flanders.bio and its members
Mithra Submits Myring™ for European Marketing Approval
Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, announces that it has filed Myring™ for marketing approval in Europe. Myring™ is Mithra’s version of Nuvaring™, a combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA). The global market for Nuvaring™ amounts to approximately USD 960 million, with over 75% of sales in the US.
Ablynx proposes appointment of Mrs. Hilde Windels as a new independent director
Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced that Hilde Windels will be nominated as an Independent Non-Executive Director at the Company's forthcoming Special General Meeting of its shareholders to be held on 18 August 2017
Delphi Genetics receives GMP accreditation for plasmid DNA bioproduction
Delphi Genetics, a company specialized in genetic engineering, is very pleased to announce that it has just received the certificate of Good Manufacturing Practice (GMP) for plasmid DNA production. The GMP productions will be realized in clean rooms located in Delphi Genetics’ own facilities.
Biocartis Group NV: Biocartis' Idylla(TM) Instrument and Idylla(TM) Console exempt from US FDA 510(k) notification requirements
Biocartis Group NV ('Biocartis' or the 'Company'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces that on 11 July 2017 the US FDA published a final list of devices that it has exempted from 510(k) premarket notification requirements in accordance with the US 21st Century Cures Act (signed into US law 13 December 2016). The product code applicable to the Biocartis Idylla(TM) Instrument and Idylla(TM) Console is included on this list. Consequently, Biocartis' Idylla(TM) Instrument and Idylla(TM) Console are no longer subject to 510(k) notification requirements prior to being placed on the US market for in vitro diagnostic use with FDA approved or cleared assays. All other US 510(k) requirements, including current Good Manufacturing Practices (cGMP) and vigilance reporting, remain in effect. With this exemption in place, Biocartis is complying with the instructions in the publication and can now withdraw the pending 510(k) submission for the Idylla(TM) Instrument and Idylla(TM) Console.