Trials & Filings
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301 - 315 of 604 results
September 9, 2008
Pfizer will globally withdraw all dalbavancin marketing applications for the treatment of complicated skin and skin structure infections in adults, including the U.S. NDA and the European MAA.
Following feedback from regulatory…
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August 29, 2008
Novartis has discontinued development of Aurograb, an add-on therapy to antibiotics that was being assessed for use in treating deep-seated staphylococcal infections, following a review of recent Phase II results showing a lack of efficacy.
&n…
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August 28, 2008
Genentech, Inc. will initiate a Phase II trial of GDC-0449, an orally administered small molecule Hedgehog antagonist, as a maintenance therapy for ovarian cancer patients in second or third complete remission. Genentech is developing the drug in col…
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August 27, 2008
Bristol-Myers Squibb and Pfizer reported that an interim analysis of results from a Phase III study of apixaban for the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement indicate that the primary endpoint of this stud…
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August 26, 2008
Morphotek, Inc., a subsidiary of Eisai Corp. of North America, has opened clinical sites in the EU as part of its Phase II study of MORAb-009. A monoclonal antibody to mesothelin, MORAb-009 is being studied as a first-line treatment for patients with…
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August 25, 2008
The FDA has approved Amgen's Nplate, the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA…
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August 22, 2008
Biogen Idec initiated a Phase III trial of intravenous (IV) Adentri (BG9928), an adenosine A1 receptor antagonist for acute decompensated heart failure (ADHF) patients with renal insufficiency. The trial will evaluate Adentri — developed under…
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August 21, 2008
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals began enrolling patients in the STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) trial. The randomized, double-blind, placebo-controlled Phas…
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August 18, 2008
AMRI initiated a Phase I study of ALB109564(a), a tubulin inhibitor designed to kill cancer cells by preventing cell mitosis. The study will be conducted at four trial sites for a period of nine to 12 months and will include as many as 40 subjects. T…
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August 11, 2008
Merck is reevaluating the design of its Phase IIb trial for I-vation TA that it's conducting with SurModics, Inc. and therefore suspending enrollment of new patients in the trial. The decision follows recent study results comparing laser treatment an…
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August 8, 2008
Centocor's BLA for ustekinumab for the treatment of plaque psoriasis has been delayed by three months to December 2008. Centocor filed the BLA late in 2007.
The FDA extended the review period in order to review amendments to the…
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July 30, 2008
Johnson & Johnson has submitted an NDA for rivaroxaban to the FDA. The drug, an investigational, oral, once-daily anticoagulant for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replac…
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July 28, 2008
Millennium, a division of Takeda, has begun two Phase I trials of MLN4924, a first-in-class, small molecule inhibitor of the Nedd 8 Activating Enzyme (NAE), a target discovered by the company. MLN4924 advanced to the clinic with the first patient dos…
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July 25, 2008
Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., itself a division of Johnson & Johnson, received approval from the FDA for pediatric exclusivity for Topamax for use in patients aged 1 to 24 months with partial…
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July 23, 2008
Bristol-Myers Squibb and AstraZeneca have submitted an NDA to the FDA and a MAA to the EMEA for Onglyza (saxagliptin) for the treatment of type 2 diabetes.
The submissions are based on data from a clinical program conduct…
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