Valeant Pharmaceuticals International, Inc.’s wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for VESNEO™ (latanoprostene bunod ophthalmic solution 0.024%), an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma or ocular hypertension. If approved, VESNEO will be the first nitric oxide donating prostaglandin receptor agonist available for the above indication.
CTI BioPharma Corp. announced its plan to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) following a productive pre-NDA meeting for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The company expects to submit the NDA in the fourth quarter of 2015 and to request accelerated approval for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter (trials, could potentially reduce time to market by up to 14 months.
Enox Biopharma, Ltd., a leader in nitric oxide delivery technology for the prevention of hospital acquired infections announced today the enrollment of the first subjects in a phase 1a/1b study for the evaluation of the safety and tolerability of Nitric Oxide (NO) impregnated urinary catheters. The study primary aim of this first in man study is to assess the safety and tolerability of NO-charged Foley catheters left in place for 7 to 14 days following surgical removal of the prostate. This two-arm study will also measure and compare the biofilm formation on the surface of NO charged versus non-NO charged Foley catheters as well as measure the presence of bacterium in the urine of subjects managed with the different catheter types.
TxCell undertaking one of largest ever controlled studies for a personalized T cell immunotherapy product .
Top line results of this study are expected end 2016/early 2017.
TxCell SA (FR0010127662 – TXCL), a biotechnology company developing novel and innovative, cost-effective personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces today that it has enrolled the first patient in its phase IIb clinical trial of its lead product Ovasave(R) in refractory Crohn’s disease. TxCell has received approval for this multi-center, multinational trial from the regulatory authorities in all six European countries in which the trial will be performed. Top line results of this study are expected at the end of 2016 to early 2017.
Merck known as MSD outside the United States and Canada, today announced that the two pivotal Phase 3 clinical studies for bezlotoxumab, its investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence, met their primary efficacy endpoint: the reduction in C. difficile recurrence through week 12 compared to placebo, when used in conjunction with standard of care antibiotics for the treatment of C. difficile. Based on these results, the company plans to submit new drug applications seeking regulatory approval of bezlotoxumab in the U.S., EU and Canada in 2015. Currently, there are no therapies approved for the prevention of recurrent disease caused by C. difficile.
Sativex (nabiximols) is derived from cannabis and usually used to treat the symptoms of multiple sclerosis (MS). This trial was testing the drug for the treatment of patients with advanced cancer where opioid therapy does not adequately reduce their pain, but it did not demonstrate a statistically significant difference from placebo.
Sanofi and Regeneron Pharmaceuticals have reported positive results from the interim analysis of a dose-ranging Phase IIb trial of dupilumab, a fully-human monoclonal antibody, in adult patients with uncontrolled moderate-to-severe asthma.