Search Results for:
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Teva Pharmaceutical Industries Ltd.
Completed a study showing it can slow disease progression 6/08BioWorld Phase III Report | Friday, July 31, 2009 -
Teva Pharmaceutical Industries Ltd.
Data showed that early treatment of Copaxone reduced the risk for developing definite multiple sclerosis by 45% vs. placebo 4/08BioWorld Phase III Report | Friday, July 31, 2009 -
Talecris Biotherapeutics Inc.
Phase III data suggested the therapy with Gamunex may improve physical and social functioning compared to placebo; FDA approved Gamunex 9/08BioWorld Phase III Report | Friday, July 31, 2009 -
Symbollon Pharmaceuticals Inc.
Completed its IoGen Phase III pivotal trial 2/08; Phase III data showed it failed to reach statistical significance 4/08BioWorld Phase III Report | Friday, July 31, 2009 -
Somaxon Pharmaceuticals Inc.
Missed primary endpoint in a Phase II/III trial 12/06BioWorld Phase III Report | Friday, July 31, 2009 -
Somaxon Pharmaceuticals Inc.
Data from third Phase III trial showed statistically significant improvement in subjective total sleep time 11/06; Phase III data demonstrated a statistically significant improvement 12/06; FDA wants results from a 26-week transgenic mouse carcino-genicity study included as part of the initial NDA submission 5/07; submitted an NDA 1/08; FDA accepted for filing the NDA 4/08; data demonstrated statistically significant differences relative to placebo for their primary endpoints and multipleBioWorld Phase III Report | Friday, July 31, 2009 -
SkyePharma plc and GlaxoSmithKline plc
Began Phase III trials 7/03; French officials approved Requip; FDA accepted for filing the marketing application 4/07; received FDA approval 6/08BioWorld Phase III Report | Friday, July 31, 2009 -
Sirion Therapeutics Inc.
Began enrolling patients in two Phase III trials 1/07; started a Phase III program 5/07BioWorld Phase III Report | Friday, July 31, 2009 -
Shire plc
Pivotal data showed significant efficacy in reducing ADHD symptoms compared to placebo 5/08BioWorld Phase III Report | Friday, July 31, 2009 -
Shire plc
Phase III data showed that 95% of children taking Vyvanse daily for 12 months had overall improvement 5/07; submitted an sNDA 7/07; FDA granted marketing approval for use in adults 4/08; Phase III data showed significant improvements in adult symptoms; it met all safety and efficacy endpoints 5/08BioWorld Phase III Report | Friday, July 31, 2009 -
Sepracor Inc.
Phase III data demonstrated that the drug, in combination with other anti-epileptic agents, significantly reduced the frequency of partial seizures in patients with refractory partial epilepsy 9/08BioWorld Phase III Report | Friday, July 31, 2009 -
Sciele Pharma Inc. and Addrenex Pharmaceuticals Inc.
Phase III data showed statistically significant improvement over placebo 9/08BioWorld Phase III Report | Friday, July 31, 2009 -
Santhera Pharmaceuticals AG
Began a Phase III program in the U.S. 9/07BioWorld Phase III Report | Friday, July 31, 2009 -
QRxPharma Pty. Ltd.
Treated patients in the first of several studies in an ongoing Phase III program 11/07; began its second Phase III trial 12/07; Phase III data showed that 50% of patients reported good to excellent global improvement and demonstrated a strong dose-response effect 5/08BioWorld Phase III Report | Friday, July 31, 2009 -
Prestwick Pharmaceuticals Inc.
Filed NDA with FDA 4/05; pivotal Phase III trial demonstrated significantly improved clinical outcomes and reduced symptoms 2/06; FDA issued an approvable letter that said certain undisclosed conditions must be met before it could be approved 3/06; clinical data showed it maintained reduction of chorea up to 80 weeks in patients who completed treatment in a 13-week trial 5/07; FDA approved Xenazine 8/08BioWorld Phase III Report | Friday, July 31, 2009 -
ProEthic Pharmaceuticals Inc.
Plans to file NDA based on positive Phase III data showing it reached all of its primary endpoints 1/07; Phase III data showed the drug relieved migraine pain within 30 minutes 6/07; submitted an NDA 7/07BioWorld Phase III Report | Friday, July 31, 2009 -
Predix Pharmaceuticals Inc.
Began pivotal Phase III 8/05; reached agreement with FDA on SPA for 310-patient pivotal Phase III trial that began in August 11/05BioWorld Phase III Report | Friday, July 31, 2009 -
Pipex Pharmaceuticals Inc.
Started a Phase II/III trial 6/07; started dosing in a Phase II/III trial for women with relapsing-remitting MS 7/07BioWorld Phase III Report | Friday, July 31, 2009 -
Pain Therapeutics Inc.
Achieved its primary endpoint in a second Phase III trial 12/07; submitted NDA to the FDA 6/08; Phase III data showed the drug provides effective around-the-clock analgesia in a formulation designed to resist common methods of misuse and abuse 8/08; in an unofficial vote, more than half of 19 federal advisers said the data were sufficient in showing that Remoxy would be less susceptible to abuse and misuse than other currently marketed therapies 11/08; FDA issued complete response letter 12/08BioWorld Phase III Report | Friday, July 31, 2009 -
Pain Therapeutics Inc.
Began another Phase III trial 12/06BioWorld Phase III Report | Friday, July 31, 2009
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