– ASCO® recommends MammaPrint® for clinical high risk, hormone receptor-positive, HER2- negative breast cancer, to inform decisions on withholding chemotherapy ASCO recommends MammaPrint as currently the only genomic test to be used to guide treatment decisions for 1-3 lymph node positive…
– IRVINE, CA and AMSTERDAM – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics announces that the 15th St. Gallen International Breast Cancer Guidelines recently published in Annals of Oncology1 have recommended the MammaPrint® 70-Gene Breast Cancer…
– Malta STAT-Dx EUR 20 million EIB loan facility under the InnovFin programme to support medical diagnostics innovation in Spain The EIB is providing STAT-Dx (STAT-Diagnostica & Innovation, S.L.), a Spanish company developing advanced molecular diagnostic systems to help combat…
– IRVINE, CA and AMSTERDAM – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, today announces that Blue Shield of California has updated its Medical Policy 2.04.36 Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis…
– Key Updates ProQR receives Fast Track designation by the U.S. Food and Drug Administration (FDA). Closer interaction with FDA could potentially accelerate the development of QR-110 in patients with Leber's Congenital Amaurosis Type 10 (LCA 10). LCA 10 is one of the most prevalent…
– Recruitment of 301 patients in STOP-AKI adaptive Phase II trial marks largest ever therapeutic study in AKI Bunnik, The Netherlands — AM-Pharma B.V., a biopharmaceutical company focused on the development of recombinant human Alkaline Phosphatase (reCAP) for inflammatory diseases,…
– Key updates With the clearance of the investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA), ProQR can now start clinical development of QR-110 in Leber's congenital amaurosis Type 10 (LCA 10) patients LCA 10 is one of the most prevalent forms…
– Funding Intended to Support FDA Approval and Early US Commercialization of Unicompartmental Load Absorber for Knee Osteoarthritis HAYWARD, California - Moximed®, Inc., developer of unicompartmental load absorber implants for active patients with painful knee osteoarthritis (OA),…
– Bedford, Massachusetts — Otto Bock HealthCare GmbH, a global leader in prosthetics and orthotics, announced the acquisition of BionX Medical (BionX), a US-based portfolio company of Gilde Healthcare. BionX's flagship product is emPOWER, the world's only active prosthetic foot that…
– Utrecht, the Netherlands — Gilde Healthcare today announces its investment in Breath Therapeutics, a company developing advanced drug-aerosol therapeutics in pulmonary orphan indications. Gilde Healthcare participated in a €43.5 million Series A financing round together with Sofinnova…
– NDA to be submitted to the US FDA 1H 2017 Cambridge, UK – Acacia Pharma Group Ltd ("Acacia"), the supportive care company, announces positive results from its fourth and final pivotal Phase 3 study investigating its lead product BAREMSIS™ for the rescue treatment of patients who…
– Shock Absorber for the Knee Targets Patients Who Are Seeking Alternatives to Joint Replacement HAYWARD, Calif. – Moximed®, Inc. announced today that the first patient has been treated in an FDA-approved IDE study for its latest generation unicompartmental unloading implant, the Atlas…
– Topline data to be presented today at NACFC LEIDEN, the Netherlands (GLOBE NEWSWIRE) -- ProQR Therapeutics N.V. (Nasdaq:PRQR) today announced that clinical study PQ-010-002, a proof-of-concept study of nasal potential difference (NPD), demonstrated that QR-010 restored CFTR function…
– San Diego, USA and Palma, Spain - Laboratoris Sanifit S.L., a clinical-stage biopharmaceutical company focused on treatments for calcification disorders, today announced successful initiation of the first clinical trial of its lead candidate, SNF472, for the treatment of the orphan…
– Funding will be used to support go-to-market activities in Europe BARCELONA – Medical diagnostics company STAT-Diagnostica has closed an extension of its Series C financing with Siemens Venture Capital. The additional proceeds will be used to support the 2017 European launch of its…
– Acacia Pharma announces positive results from a pivotal Phase 3 trial of BAREMSIS™ for the treatment of post-operative nausea and vomiting BAREMSIS now shown to treat PONV, as well as prevent it Cambridge, UK – Acacia Pharma Group plc ("Acacia Pharma"), the supportive care company…
– Board will be strengthened with industry experts and Enrique Vega appointed as new CEO Mont-Saint-Guibert, Belgium – Nyxoah S.A., a medical device company focused on developing a neurostimulation based, disruptive therapy for patients suffering from Obstructive Sleep Apnea (OSA),…
– Former Head of R&D at Orexigen Therapeutics and Therapeutic Area Head for Nephrology at Amgen appointed as CMO CMO appointment and launch of US subsidiary are significant steps in establishing a US presence Palma de Mallorca, Spain - Laboratoris Sanifit S.L., a clinical-stage biopharmaceutical…
– Results from Multi-center, Prospective Study with Unicompartmental Joint Unloading Device for the Knee Presented at ESSKA / Moximed Commercializing Atlas System in Europe
– Agendia, Inc. announced that using the company's MammaPrint® assay, patients with early-stage breast cancer who were considered at high risk for disease recurrence based on clinical and biological criteria can avoid chemotherapy.