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InSite Vision Inc.
Began pivotal trials 7/04 pivotal Phase III trial in 746 patients showed clinical resolution equivalent to tobramycin, the primary efficacy endpoint 11/05; submitted NDA 6/06; FDA accepted NDA for review 8/06; filed a new drug submission with Health Canada 12/07BioWorld Phase III Report | Friday, July 31, 2009 -
Inhibitex Inc.
Phase III trial in 2,017 infants failed to meet its primary endpoint of reducing infections 4/06BioWorld Phase III Report | Friday, July 31, 2009 -
Indevus Pharmaceuticals Inc.
A data monitoring committee recommended the low-dose arm continue and the high-dose arm be stopped in a trial 2/08; completed enrollment of its Phase III trial 8/08BioWorld Phase III Report | Friday, July 31, 2009 -
Indevus Pharmaceuticals Inc.
Preliminary data indicate an ongoing Phase III will achieve its primary endpoint 3/07; Phase III data showed that 94% of patients receiving 1,000 mg of Nebido and 86% of those receiving 750 mg achieved a normal testosterone level 6/07; filed with the FDA seeking approval 08/07BioWorld Phase III Report | Friday, July 31, 2009 -
Idenix Pharmaceuticals Inc.
Began a Phase III 1/03; Phase III Globe trial met primary endpoint 7/05BioWorld Phase III Report | Friday, July 31, 2009 -
ID Biomedical Corp.
FDA said product is eligible for accelerated approval and priority review 3/05; FDA granted fast-track status 7/05BioWorld Phase III Report | Friday, July 31, 2009 -
Human Genome Sciences Inc.
Started dosing in ACHIEVE 1, one of two Phase III trials of Albuferon in combination with ribavirin 12/06; began dosing in a Phase III trial of Albuferon in combination with ribavirin in treatment-naive patients 2/07; completed enrollment in a Phase III trial 8/07; an independent data monitoring committee found a higher rate of serious pulmonary adverse events in the higher dose group, prompting HGS to reduce dosing in the two Phase III trials 1/08; data showed Albuferon in combination withBioWorld Phase III Report | Friday, July 31, 2009 -
Gilead Sciences Inc.
FDA wants an additional clinical study before it considers approving the product; it did not raise any significant safety concerns in a complete response letter 9/08BioWorld Phase III Report | Friday, July 31, 2009 -
Gilead Sciences Inc.
Started the first of two Phase III trials 7/08BioWorld Phase III Report | Friday, July 31, 2009 -
Gilead Sciences Inc.
Phase III data showed 71% of Truvada/Sustiva patients compared to 58% of Combivir/Sustiva patients achieved and maintained viral load less than 400 copies/mL 7/07; patients taking Sustiva who switched from Combivir to Truvada maintained virologic suppression and decreased certain side effects 10/07BioWorld Phase III Report | Friday, July 31, 2009 -
Gilead Sciences Inc.
Phase III data showed it met the primary endpoint of non-inferiority to once-daily Hepsera; a second Phase III also met the primary endpoint 6/07; filed for approval in the U.S. and Europe 10/07; Phase III data showed superior efficacy results in Viread-treated patients compared to those receiving Hepsera 11/07; two Phase III trials demonstrated that the majority of patients who had received Viread had virologic response below 400 copies/ml through week 72; European Commission granted marketingBioWorld Phase III Report | Friday, July 31, 2009 -
Gilead Sciences Inc. and F. Hoffmann-LaRoche Ltd.
Roche filed an sNDA to market 30-mg and 45-mg pediatric doses of Tamiflu 03/07BioWorld Phase III Report | Friday, July 31, 2009 -
Genzyme Corp.
Began Phase III trial vs. vancomycin 4/05; product failed to beat the standard prescribed oral dose of vancomycin in the first of two Phase III trials 7/07BioWorld Phase III Report | Friday, July 31, 2009 -
Forest Laboratories Inc.
Phase III data showed it met its primary endpoint 06/08BioWorld Phase III Report | Friday, July 31, 2009 -
Dynavax Technologies Inc.
Began pivotal Phase III trial in Canada 12/06; completed enrollment in Phase III trial in Canada and Germany 7/07; Phase III data showed drug provided seroprotection to all subjects vs. 68.6% for those treated with Engerix-B 9/07; FDA put a clinical hold on Heplisav after a possible case of vasculitis in a Phase III trial 3/08; Phase III data showed it met its primary endpoint of inducing a non-inferior antibody response 08/08BioWorld Phase III Report | Friday, July 31, 2009 -
CSL Biotherapies
Submitted BLA for an influenza vaccine 4/07; Phase III data showed that two formulations elicited immune response 9/08BioWorld Phase III Report | Friday, July 31, 2009 -
Corus Pharma Inc.
Began AIR-CF2 Phase III trial in cystic fibrosis patients 4/05BioWorld Phase III Report | Friday, July 31, 2009 -
Cellegy Pharmaceuticals Inc.
Phase III data were positive; another Phase III began 9/02; trial showed efficacy 1/04; filed NDA on new data 6/04; approved in UK as Rectogesic 9/04; FDA accepted NDA 9/04; FDA issued not-approvable letter 12/04; submitted another NDA 6/05; remains under FDA review 11/05; FDA issued an approvable letter that calls for an additional trial 7/06BioWorld Phase III Report | Friday, July 31, 2009 -
Cell Therapeutics Inc.
Began a Phase III trial 7/02; began trial in patients in remission 3/05BioWorld Phase III Report | Friday, July 31, 2009 -
Cell Therapeutics Inc.
Phase III EXTEND trial to continue after positive response data 8/06; filed SPA with the FDA for design of Phase III PIX303 trial 3/07; interim data indicated complete or partial responses 7/07; launched a Phase III trial 9/07; Phase II/III data showed patients experienced less severe toxicities than those treated with standard doxorubicin-based therapy 12/07; completed enrollment in its Phase III study 3/08; met its primary endpoint in a pivotal trial 11/08; data showed a statisticallyBioWorld Phase III Report | Friday, July 31, 2009
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