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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 - 2014-03-27 23:00 - 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 - 2014-03-27 23:00 - 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 - 2014-03-26 23:00 - 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 - 2014-03-26 23:00 - 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 - 2014-03-25 23:00 - 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 - 2014-03-25 23:00 - 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 - 2014-03-24 23:00 - 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 - 2014-03-23 23:00 - 0 comments - 0 attachments

Clinic roundup

Synta Pharmaceuticals Corp. , of Lexington, Mass., said interim results from the ENCHANT-1 trial, a single-arm multicenter phase II proof-of-concept study designed to evaluate ganetespib, administered as a monotherapy for the treatment of metastatic ...

BioWorld Today - Staff - 2014-03-20 23:00 - 0 comments - 0 attachments

Pharma: clinic roundup

Abbvie Inc. , of North Chicago, Ill., said a pivotal phase III trial that will evaluate the use of Humira (adalimumab) as a treatment for fingernail psoriasis in patients with moderate to severe chronic plaque psoriasis, has been initiated. ...

BioWorld Today - Staff - 2014-03-20 23:00 - 0 comments - 0 attachments