– The Hague, the Netherlands – NightBalance, a leader in innovative obstructive sleep apnea therapies, today announced that the Dutch National Health Care Institute (ZIN) issued a positive recommendation to include its sleep apnea therapy for reimbursement. The Sleep Position Trainer…
– Former SVP and Head of Clinical Development at Portola Pharmaceuticals appointed as Chief Medical Officer Palma, Spain and San Diego, USA – Laboratoris Sanifit S.L., a clinical-stage biopharmaceutical company focused on treatments for calcification disorders, today announces the…
– Irvine, CA – Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of bladder and bowel dysfunction, announced today that the United States Patent and Trademark Office has granted Axonics seven new U.S.…
– Top-tier drug development executive joins Board of Directors Important reinforcement for development of lead program in Bronchiolitis Obliterans Munich, Frankfurt, Boston - Breath Therapeutics B.V. (Breath), a company developing advanced drug-aerosol therapeutics in pulmonary…
– LEIDEN, The Netherlands (GLOBE NEWSWIRE) -- ProQR Therapeutics N.V. (Nasdaq:PRQR), a biopharmaceutical company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, today announced the pricing of its previously…
– Key Updates The first patient has received the first dose of QR-110 in the Phase 1/2 safety & efficacy clinical trial (PQ-110-001: NCT03140969) in children and adults with Leber’s congenital amaurosis 10 (LCA 10). LCA 10 is one of the most prevalent forms of gene-related blindness…
– Irvine, CA – Axonics Modulation Technologies, Inc., developer of the first rechargeable sacral neuromodulation (r-SNM™) system for the treatment of overactive bladder (OAB) and bowel dysfunction, today announced the U.S. Food & Drug Administration (FDA) has granted an Investigational…
– Leading Care Pathway Management Platform to Dynamically Personalize and Streamline Surgery Experience for Patients BOSTON – Lumeon, the leader in Care Pathway Management, today announced its participation in the Cedars-Sinai Accelerator Powered by Techstars. Through the Accelerator,…
– Issued Patent in the U.S. Covers Use of FIX-Padua in Gene Therapy Divisional patent applications filed to further strengthen Padua intellectual property position LEXINGTON, Mass. and AMSTERDAM, the Netherlands (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy…
– AMT-060 with the FIX-Padua Modification (AMT-061) Demonstrates Substantial Increase in FIX Activity in Non-human Primates Plans to Initiate Pivotal Study with Enhanced AMT-061 in 2018 Achieves Alignment with FDA on Streamlined Clinical and Regulatory Strategy for AMT-061, Which…
– NightBalance announced the publication of a study comparing its innovative "Sleep Position Trainer" (SPT) to the historic standard of care oral appliance therapy (OAT) in mild to moderate positional obstructive sleep apnea (POSA) over a 12-month period.
– ProQR Therapeutics today announced positive preliminary top-line results from a Phase 1b safety and tolerability clinical trial of QR-010, a novel investigational RNA therapeutic in subjects with cystic fibrosis (CF).
– Sandwich, UK -- Levicept Ltd., an asset-centric biotechnology company focused on the development of LEVI-04, a first-in-class treatment for chronic pain indications, today announces that it has commenced its Phase I trial of LEVI-04 in healthy volunteers and osteoarthritis patients…
– Irvine, CA and Florence, Italy – Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction, today announced the presentation of positive results from its prospective, multicenter…
– Data show clinically meaningful improvement in overall survival in a biomarker-defined patient population with late-stage metastatic colorectal cancer COPENHAGEN, Denmark - Symphogen, an advanced clinical-stage antibody company focused on oncology, today announced detailed results…
– IRVINE, Calif. - Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM(tm)) system for the treatment of urinary and bowel dysfunction, today announced the appointment of Karen L. Noblett, M.D., M.A.S., a urogynecologist and prolific…
– Key Updates Last patient received their final dose in the PQ-010-001 Phase 1b clinical trial of QR-010 in CF patients with the F508del mutation. Top-line trial data are expected to be issued in a press release post-market close on Monday, September 25, 2017, followed by a conference…
– UTRECHT, THE NETHERLANDS – Gilde Healthcare, the European specialist investor, today announces it has sold its majority share in Viroclinics Biosciences (Viroclinics), the contract research organization (CRO), to Parcom Capital. Gilde Healthcare invested in 2013 out of its Gilde…
– Utrecht, the Netherlands — Gilde Healthcare, the European specialist investor in healthcare, together with Dutch pension service provider PGGM, as co-investor, have invested in Mercachem and Syncom, two of the leading European drug discovery Contract Research Organizations (CRO).…
– 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…
– Utrecht, the Netherlands — Gilde Healthcare today announces its investment in Axonics (Paris, France and Irvine, US), developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction. Gilde Healthcare participated in a EUR…
– LONDON AND NEW YORK – Lumeon, a leading digital health company, has won the MedTech Breakthrough Award for Best Overall Health Administration Software. The awards recognize the top companies, people, platforms and products in the global health and medical technology market today. Lumeon’s…
– 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…
– LONDON AND NEW YORK – Today at HIMSS, Lumeon, a leading digital health company, and Digital Noema Telehealth (DN Telehealth), a provider of telemedicine and remote patient monitoring, announce they are partnering to optimize care pathways for telemedicine reimbursements. DN Telehealth…
– 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…
– RAD-x closes its first transaction: IRD SA, a leading Swiss Diagnostic Imaging Centre RAD-x announced that it has acquired Geneva-based IRD SA, a leading diagnostic imaging provider. The sellers of IRD SA will reinvest part of the proceeds in the RAD-x holding and join the Gilde…