PRNewswire/ -- Cantrixil (TRX-E-002-1) is Novogen's lead development candidate, and is being developed as an intraperitoneal therapy for patients with ovarian cancer Investigational New Drug (IND) application is the key regulatory filing to initiate clinical trials in the United States First-in-human (FIH) phase I study remains on track for initiation in 4Q 2016, as per previous guidance Australian oncology-focused biotechnology company Novogen Ltd (ASX: NRT; NASDAQ: NVGN) today announced that it had received confirmation from the United States Food and Drug Administration (FDA) that the Investigational New Drug (IND) application for Cantrixil (TRX-E-002-1) had been successfully opened, and the phase I study of Cantrixil in patients with ovarian cancer may therefore proceed as planned
Long-term Analysis of All 695 Patients Enrolled in Novocure’s Phase 3 Pivotal Trial in Newly Diagnosed Glioblastoma Confirms Superior Progression Free and Overall Survival Seen in the Trial’s Interim Analysis
ST. HELIER, JERSEY--(BUSINESS WIRE)--Novocure (NASDAQ:NVCR) announced today that long-term survival analysis of the full 695 patient dataset from the phase 3 pivotal EF-14 trial of Optune in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) will be presented as a late-breaking oral presentation at the 21st Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) in Scottsdale, Arizona, on Friday, Nov. 18, 2016.
Alkermes Launches Competitive Grants Program to Support People Affected by Mental Health and Substance Use Disorders
DUBLIN--(BUSINESS WIRE)--Alkermes plc (NASDAQ: ALKS), a global biopharmaceutical company developing medicines for the treatment of central nervous system (CNS) diseases, such as schizophrenia, major depressive disorder and multiple sclerosis, today announced a new competitive grant program. ALKERMESTM Inspiration Grants are designed to fund high-impact programs that can be replicable through the ecosystem for people affected by mental health and substance use disorders. The application period is now open and will run until Oct. 7, 2016.
Celgene Announces Interim Topline Data from Trial of Investigational Oral GED-0301 in Patients with Active Crohn’s Disease
SUMMIT, N.J.--(EON: Enhanced Online News)--Celgene Corporation (NASDAQ:CELG) today announced interim topline data from a randomized, double-blind, multicenter, exploratory phase 1b study evaluating the effects of oral GED-0301 (mongersen) on both endoscopic and clinical outcomes in patients with active Crohn’s disease. “These data are particularly encouraging for several reasons, including the difficult-to-treat patient population evaluated in the trial.” The trial, CD-001, is an ongoing study evaluating three different treatment regimens of GED-0301 in a 12-week treatment phase, followed by an observation phase up to 52 weeks (off treatment). The primary objective of the study is to explore the effect of GED-0301 on endoscopic outcomes. The trial enrolled a total of 63 patients across multiple countries.
Janssen Submits Marketing Authorisation Application for Darunavir-Based Single Tablet Regimen for Treatment of HIV-1 to European Medicines Agency
BEERSE, Belgium--(BUSINESS WIRE)--Janssen-Cilag International NV (Janssen) today announced the submission of a Marketing Authorisation Application to the European Medicines Agency (EMA), seeking approval for a new once-daily darunavir-based single tablet regimen (STR). If approved, this tablet would be the first protease inhibitor (PI)-based STR option (D/C/F/TAF FDC), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight of at least 40 kg). This new treatment would combine the protease inhibitor, darunavir (DRV, D, 800 mg), with the pharmacokinetic enhancer, cobicistat (COBI, C, 150 mg) and the nucleoside reverse transcriptase inhibitors emtricitabine (FTC, F, 200 mg) and tenofovir alafenamide (TAF 10 mg), in one single tablet.
Darmstadt, Germany, September 12, 2016 – Merck, a leading science and technology company, today announced the recipients of the Grant for Growth Innovation (GGI) for 2016. The awards were announced yesterday evening at an award presentation meeting organized by Merck during the 55th European Society for Pediatric Endocrinology (ESPE) Meeting in Paris, France. Merck is providing grants to pioneers of new research in growth through the Grant for Growth Innovation award. Identifying and supporting forward thinking researchers in the field of growth follows Merck´s scientific strategy of providing a platform that makes innovation possible.