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CTI BioPharma To Submit NDA For Pacritinib In Q4 Based Primarily On Data From Single Pivotal Persist-1 Trial

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...

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:...

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...

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...

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,...

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...

Sarepta doses first patient in eteplirsen trial to treat duchenne muscular dystrophy

US-based Sarepta Therapeutics has started dosing patients in a clinical trial of its lead exon-skipping therapeutic candidate eteplirsen to treat Duchenne muscular dystrophy (DMD). The open-label trial (Study 204) will be carried out in DMD patients...

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