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Archive for December 2016 - News

Archive for December 2016 - Nieuws

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FlandersBio informs you about important regional and national life sciences news. Send us your news. If your news is of interest to the life sciences community, we will post it on our website.

FlandersBio informeert u over belangrijk nieuws op het vlak van de biowetenschappen. Bezorg ons jouw nieuwtjes. Als het interessant is voor de sector, zullen wij het op onze website plaatsen.

Genticel and Genkyotex Announce Intention to Enter into Strategic Combination

23.12.2016

Genkyotex is a pioneer in discovery and development of NOX therapeutics read more

TiGenix Submits Day 120 Responses to European Medicines Agency for Cx601 Marketing Authorization

23.12.2016

TiGenix NV (Euronext Brussels and Nasdaq: TIG), an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, today announced that it has submitted its responses to the European Medicines Agency's (EMA) Day 120 List of Questions for Cx601, its lead product candidate being developed for the treatment of complex perianal fistulas in patients with Crohn's disease. read more

FMR LLC ANNOUNCE 9.16% SHAREHOLDING IN ABLYNX

23.12.2016

Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced, in accordance with Article 14 of the Belgian Law of 2 May 2007 regarding the publication of major shareholdings in issuers whose securities are admitted to trading on a regulated market (the "Transparency Law"), that it received a notification of shareholdings from FMR LLC. read more

ThromboGenics NV : ThromboGenics Announces Protocol Amendment to Phase II CIRCLE Trial Evaluating THR-409 (ocriplasmin) in Patients with Non-Proliferative Diabetic Retinopathy (NPDR)

23.12.2016

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company developing novel medicines for back of the eye disease, with a focus on diabetic eye disease, today announced that the protocol of the Phase II CIRCLE Trial Evaluating Multiple Doses of THR-409 to induce a Total Posterior Vitreous Detachment in Patients with Non-Proliferative Diabetic Retinopathy (NPDR) has been amended. read more

Mithra Launches its Product Tibelia on the Global Market

22.12.2016

Mithra Pharmaceuticals, a company focused on Women’s Health, announces today that it obtained 14 Marketing Authorizations for the commercialization of its product Tibelia in the United Kingdom, Belgium, Holland, Luxembourg, Spain, Portugal, Germany, Hungary, Poland, Norway, Sweden and Finland. Mithra is still waiting for 3 MA in France, Greece and Italy that should be received by the beginning of 2017. The product based on tibolone developed by Mithra will be more competitive due to its extended shelf-life. read more

Biocartis Group NV: Biocartis and Amgen sign a RAS Biomarker Testing Collaboration in Europe

22.12.2016

Biocartis Group NV ('Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced the signing of a new collaboration agreement with Amgen, a leading biotechnology company. The new agreement, which builds on the existing collaboration between both companies announced on 3 February 2016[1], aims at accelerating access to RAS biomarker information in up to 10 European countries. read more

Biocartis Group NV: Biocartis submits 510(k) file with US FDA for Idylla(TM) platform

22.12.2016

Biocartis Group NV ('Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced the 510(k) submission[1] to the U.S. Food and Drug Administration (FDA) of its rapid, fully automated molecular diagnostics platform Idylla(TM), consisting of the Idylla(TM) Instrument and the Idylla(TM) Console. read more

TiGenix: Takeda Exercises its Option to Develop and Commercialize Cx601 in both Japan and Canada

22.12.2016

TiGenix NV (Euronext Brussels and Nasdaq: TIG; the "Company"), an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, today announced that it has received a confirmation notification from Takeda Pharmaceuticals International AG (Takeda) stating that it has decided to exercise its option to develop and commercialize Cx601 in both Japan and Canada. read more

Kiadis Pharma provides update on second dose trial (CR-AIR-008) with ATIR101™ ~ Trial continues according to protocol with one dose ~

21.12.2016

Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces an update on the second dose Phase II trial with ATIR101™ (CR-AIR-008 ). The Company will continue its CR-AIR-008 trial, treating patients with a single dose of ATIR101™ according to the recommendation of the Independent Data Monitoring Committee (IDMC) and according to the clinical protocol. read more

Bone Therapeutics announces its financial calendar for 2017

21.12.2016

BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in the field of orthopaedics and bone diseases, today announces its financial calendar for 2017. read more

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