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Pharma: clinic roundup

Forest Laboratories Inc ., of New York, and Gedeon Richter Plc , of Budapest, Hungary, reported positive top-line results from a global, randomized, placebo-controlled, fixed-dose, eight-week phase IIb trial evaluating the efficacy and safety of c ...

BioWorld Today - Staff - 2014-04-01 00:00 - 0 comments - 0 attachments

Clinic roundup

Cytokinetics Inc. , of South San Francisco, said it began enrolling the expansion phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure). The double-blind, randomized, placebo-controlled, multicente ...

BioWorld Today - Staff - 2014-03-31 00:00 - 0 comments - 0 attachments

Clinic roundup

Bluebird Bio Inc. , of Cambridge, Mass., said the first subject with beta-thalassemia major was enrolled in its phase I/II Northstar Study (HGB-204) and has undergone infusion with the company’s Lentiglobin drug product in an autologous hematopoietic ...

BioWorld Today - Staff - 2014-03-28 00:00 - 0 comments - 0 attachments

Pharma: clinic roundup

Pfizer Inc. , of New York, and Bristol-Myers Squibb Co. , also of New York, said results of a pre-specified subanalysis of the phase III ARISTOTLE trial assessing the effect of blood pressure control on outcomes as well as the treatment effect of ...

BioWorld Today - Staff - 2014-03-28 00:00 - 0 comments - 0 attachments

Pharma: clinic roundup

Pfizer Inc ., of New York, reported top-line results from a phase IIIB study evaluating the 24-month efficacy of Genotropin (somatropin) on the height in small-for-gestational-age children 24-30 months old. (BioWorld-Today-2014-03-27) ...

BioWorld Today - Staff - 2014-03-27 00:00 - 0 comments - 0 attachments

Clinic roundup

E-Therapeutics plc , of Oxford, UK, said the Medicines and Healthcare products Regulatory Agency has allowed it to resume recruiting patients for its phase Ia trial of ETS2101 in solid tumors after a drug storage issue forced the company to halt recr ...

BioWorld Today - Staff - 2014-03-27 00:00 - 0 comments - 0 attachments

Clinic roundup

Catalyst Pharmaceutical Partners Inc. , of Coral Gables, Fla., said the independent data monitoring committee recommended that the ongoing pivotal phase III trial of Firdapse for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) continue as p ...

BioWorld Today - Staff - 2014-03-26 00:00 - 0 comments - 0 attachments

Pharma: clinic roundup

Pfizer Inc. , of New York, reported that PROFILE 1014, a phase III study testing anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib) met its primary objective of significantly prolonging progression-free survival in previously untreated p ...

BioWorld Today - Staff - 2014-03-26 00:00 - 0 comments - 0 attachments

Clinic roundup

Ariad Pharmaceuticals Inc. , of Cambridge, Mass., said it started a pivotal phase II study of AP26113 in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) who previously were treated with Xalkori (crizotinib, Pfizer Inc. ...

BioWorld Today - Staff - 2014-03-25 00:00 - 0 comments - 0 attachments

Clinic roundup

Cellceutix Corp. , of Beverly, Mass., said the FDA’s 30-day waiting period pertaining to the investigational new drug application for Prurisol has passed, and the company is moving toward starting clinical trials of the small-molecule drug in psorias ...

BioWorld Today - Staff - 2014-03-24 00:00 - 0 comments - 0 attachments