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Alexza Pharmaceuticals Inc.
Began a Phase III trial 2/08; began a second Phase III study 7/08; completed enrollment of its second trial 10/08; study showed a statistically significant reduction in agitation compared to placebo 12/08BioWorld Phase III Report | Friday, July 31, 2009 -
Acura Pharmaceuticals Inc. and King Pharmaceuticals Inc.
Phase III data showed it met the primary pain relief endpoint compared to placebo 6/08BioWorld Phase III Report | Friday, July 31, 2009 -
Active Biotech AB and Teva Pharmaceutical Industries Ltd.
Began enrolling patients in a Phase III study 11/07BioWorld Phase III Report | Friday, July 31, 2009 -
Acorda Therapeutics Inc.
Completed enrollment in its Phase III trial 11/07; Phase III data showed it does not increase a patient's risk of developing cardiac arrhythmias, or an irregular heart beat 1/08; Phase III data showed it greatly improved walking ability 6/08BioWorld Phase III Report | Friday, July 31, 2009 -
Acadia Pharmaceuticals Inc.
Acadia started the first of two pivotal Phase III trials 6/07; began its second Phase III trial 3/08BioWorld Phase III Report | Friday, July 31, 2009 -
YM BioSciences Inc. and Oncoscience AG
Started a Phase III trial in glioblastoma multiforme and a Phase IIb/IIIa trial in chemotherapy-naive patients with advanced pancreatic cancer 08/07BioWorld Phase III Report | Friday, July 31, 2009 -
YM BioSciences Inc. and Oncoscience AG
Recruited the final patient in a Phase III trial combining product with radiation to treat children and adolescents 08/07BioWorld Phase III Report | Friday, July 31, 2009 -
Xanthus Pharmaceuticals Inc.
FDA accepted for review the NDA 1/08BioWorld Phase III Report | Friday, July 31, 2009 -
Xanthus Pharmaceuticals Inc.
FDA agreed to an SPA for a Phase III trial in combination with ara-C 6/07; started patient dosing in pivotal Phase III trial 10/07BioWorld Phase III Report | Friday, July 31, 2009 -
WEX Pharmaceuticals Inc.
Dosed the first patient in a Phase III trial 4/08BioWorld Phase III Report | Friday, July 31, 2009 -
ViRexx Medical Corp.
Both Phase III trials have reached the 118th relapse event 10/07BioWorld Phase III Report | Friday, July 31, 2009 -
Vion Pharmaceuticals Inc.
Accrued 210 patients in Phase III trial 11/06; Vion suspended enrollment and further patient treatment pending a review of all data based on a recommendation of a data safety monitoring board 5/07; FDA lifted a clinical hold on the Phase III trial originally imposed because the advantage seen appeared to be compromised by the mortality observed in the study 1/08BioWorld Phase III Report | Friday, July 31, 2009 -
Vical Inc.
A pivotal Phase III trial is under way testing it as first-line therapy in chemotherapy-naive patients with recurrent Stage III or IV disease 1/07BioWorld Phase III Report | Friday, July 31, 2009 -
Trion Pharma GmbH and Fresenius Group
Phase II/III data showed it significantly increased time to tumor progression and had a positive influence on overall survival time 7/07BioWorld Phase III Report | Friday, July 31, 2009 -
TopoTarget A/S
FDA approved an SPA for a Phase III trial with 120 patients expected to begin later this year 9/08BioWorld Phase III Report | Friday, July 31, 2009 -
Threshold Pharmaceuticals Inc.
Monitors for pivotal Phase III trial recommended continuing study to completion 6/06; FDA granted orphan designation 9/06; results from Phase III trial delayed because 258th death has not yet occurred 11/06; Phase III data showed drug missed statistical significance on its primary endpoint 2/07BioWorld Phase III Report | Friday, July 31, 2009 -
Therion Biologics Corp.
FDA granted orphan designation in this indication 2/06; Phase III trial did not meet endpoint of improving survival vs. palliative chemotherapy or best supportive care, and a BLA filing was no longer planned 6/06BioWorld Phase III Report | Friday, July 31, 2009 -
Telik Inc.
Drug missed its primary endpoints of overall survival in two Phase III studies 12/06; FDA initiated a clinical hold after Phase III data detailed the failures of the ASSIST-1, -2 and -3 trials; FDA converted full clinical hold to a partial hold, allowing patients to continue receiving treatment 6/07; FDA removed the partial hold on clinical trials 10/07; stopped enrolling patients due to the interruption of a five-month clinical hold that may have caused study to miss its mark 10/08BioWorld Phase III Report | Friday, July 31, 2009 -
Synta Pharmaceuticals Corp.
Began a pivotal Phase III trial 11/07; met its target of 630 patients for a pivotal study, the SYMMETRYSM trial 2/09; company halted development due to a higher than expected death rate 2/09BioWorld Phase III Report | Friday, July 31, 2009 -
SuperGen Inc.
Dacogen failed to show a significant survival advantage compared to best supportive care in a Phase III trial 7/08BioWorld Phase III Report | Friday, July 31, 2009
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