Clinical Trials
Bausch + Lomb and Nicox Announce FDA Acceptance of New Drug Application for Novel Glaucoma Candidate VESNEO
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...
Clinical Trials
CTI BioPharma To Submit NDA For Pacritinib In Q4 Based Primarily On Data From Single Pivotal Persist-1 Trial
CTI BioPharma Corp. Â 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...
Clinical Trials
Pivotal Phase 3 Studies of Bezlotoxumab, Merck’s Investigational Antitoxin to Prevent Clostridium Difficile Infection Recurrence, Met Primary Endpoint
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:...
Clinical Trials
Enox Biopharma, LTD. Announces First Enrollments of A Phase 1a/lb Clinical Trial
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...
Clinical Trials
Otsuka and GW Pharmaceutical’s multiple sclerosis drug Sativex has failed to meet the primary endpoint in its first Phase III trials in cancer pain.
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...
Clinical Trials
TxCell announces start of phase IIb clinical trial with Ovasave(R) for refractory Crohn’s disease
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,...
Clinical Trials
Sanofi and Regeneron report positive Phase IIb trial results of dupilumab in asthma patients
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. Dupilumab is directed against the...
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