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Ligand Pharmaceuticals Inc.
Enrollment exceeded in first pivotal Phase III trial 8/03; enrollment exceeded in second pivotal Phase III trial 9/03; Phase III SPIRIT trials failed to improve survival 3/05BioWorld Phase III Report | Friday, July 31, 2009 -
Kosan Biosciences Inc.
Started a Phase II/III study 8/07; opened enrollment in Phase III 1/08BioWorld Phase III Report | Friday, July 31, 2009 -
Javelin Pharmaceuticals Inc.
Began a Phase III trial 07/07BioWorld Phase III Report | Friday, July 31, 2009 -
Janssen-Cilag and Ortho Biotech (subsidiaries of Johnson & Johnson)
Received European Commission approval as a first-line treatment for patients not eligible for high-dose chemotherapy 09/08BioWorld Phase III Report | Friday, July 31, 2009 -
Introgen Therapeutics Inc.
Met its primary and secondary endpoints in a Phase III trial 5/08; submitted its BLA 6/08; data showed patients with p53 tumor profiles positive for Advexin efficacy demonstrated statistically significant increased survival benefit at both six months and overall 7/08; EMEA accepted for review the MAA 8/08; FDA refused to accept the BLA 9/08BioWorld Phase III Report | Friday, July 31, 2009 -
Introgen Therapeutics Inc.
Began efficacy analysis of its Advexin Phase III study 4/07; Phase III data showed it significantly increased the survival of patients 4/08BioWorld Phase III Report | Friday, July 31, 2009 -
Intracel Corp.
FDA granted SPA for confirmatory pivotal Phase III trial that will include 560 patients 7/06BioWorld Phase III Report | Friday, July 31, 2009 -
Inovio Biomedical Corp.
Company halted two Phase III trials after a data monitoring committee had concerns of efficacy and higher mortality rates 6/07BioWorld Phase III Report | Friday, July 31, 2009 -
Indevus Pharmaceuticals Inc.
Submitted an sNDA seeking to reintroduce Valstar; FDA issued an approvable letter 8/07; received a non-approvable letter, related to the chemistry, manufacturing and controls supplement to the NDA in May 12/07BioWorld Phase III Report | Friday, July 31, 2009 -
ImClone Systems Inc. and BristolMyers Squibb Co.
Phase III data of Erbitux plus platinum-based chemotherapy showed a statistically significant improvement in the primary endpoint of overall survival, as well as secondary endpoints of progression-free survival and overall response rate; submitted an sBLA to broaden use in first-line patients with recurrent and/or metastatic disease 9/08BioWorld Phase III Report | Friday, July 31, 2009 -
ImClone Systems Inc.
Plans to enroll patients in a pivotal trial after reaching an agreement for an SPA with the FDA 4/08; first patient was treated in a Phase III trial 8/08BioWorld Phase III Report | Friday, July 31, 2009 -
ImClone Systems Inc. and Merck KGaA
Phase III trial missed its primary endpoint, but secondary endpoints were achieved 7/07; drug met the primary endpoint when combined with chemotherapy 9/07; Phase III data of Erbitux with taxane and carboplatin showed it did not meet its primary endpoint of progression-free survival 8/08; submitted an application to include first-line treatment of patients in combination with platinum-based chemotherapy 12/08BioWorld Phase III Report | Friday, July 31, 2009 -
ImClone Systems Inc.
Missed primary endpoint, failing to improve overall survival to a statistically significant degree in a Phase III trial 4/07BioWorld Phase III Report | Friday, July 31, 2009 -
IDM Pharma Inc.
Submitted marketing authorization application in Europe for its use in newly diagnosed resectable high-grade osteosarcoma following surgical resection in combination with post-operative multiagent chemotherapy 11/06BioWorld Phase III Report | Friday, July 31, 2009 -
IDM Pharma Inc.
Began Phase III in U.S. 3Q:94; enrollment completed 4Q:97; BLA filing expected 2Q:00; orphan drug status granted 6/01; data showed significant survival increase 6/05; filed NDA with FDA seeking approval for treating newly diagnosed resectable high-grade osteosarcoma patients following surgical resection, in combination with chemotherapy 10/06; FDA issued a not-approvable letter, asking for more clinical trial data 8/07; a long-term follow-up study showed improved overall survival of 78% comparedBioWorld Phase III Report | Friday, July 31, 2009 -
Hy BioPharma Inc.
Starting Phase III development 5/08BioWorld Phase III Report | Friday, July 31, 2009 -
GPC Biotech AG/ Pharmion Corp./Spectrum Pharmaceuticals Inc.
Pivotal SPARC trial demonstrated statistical significance vs. placebo on progression-free survival 9/06; data showed drug significantly reduced the risk of disease progression 2/07; GPC completed its submission of the rolling NDA 2/07; data showed that pain response rates for patients treated with satraplatin plus prednisone were statistically superior 3/07; FDA accepted NDA 4/07; data showed a median time to pain progression of 66.1 weeks for the satraplatin arm compared to 22.3 weeks forBioWorld Phase III Report | Friday, July 31, 2009 -
Gloucester Pharmaceuticals Inc.
Began pivotal trial 03/05BioWorld Phase III Report | Friday, July 31, 2009 -
GlaxoSmithKline plc
Submitted an NDA 5/08BioWorld Phase III Report | Friday, July 31, 2009 -
GlaxoSmithKline plc
Phase III data showed it worked better in heavily pre-treated breast cancer patients when paired with Genentech's Herceptin 5/08BioWorld Phase III Report | Friday, July 31, 2009
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