Trials & Filings
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February 26, 2007
Gilead Sciences, Inc. completed a Phase II trial of GS 9137, a novel oral HIV integrase inhibitor. The study met its primary endpoint of non-inferiority in viral load reduction in HIV-positive patients receiving 50 mg or 125 mg of GS 9137 once daily…
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February 15, 2007
Halozyme Therapeutics, Inc. and Baxter Healthcare achieved positive results from a Phase IIIB trial showing that subcutaneous administration of morphine with Hylenex recombinant (hyaluronidase human injection) accelerated the time to maximal blood le…
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February 13, 2007
Pfizer will receive accelerated review in both the U.S. and Europe for its marketing authorization applications for maraviroc. Accelerated reviews are granted to medicines that would potentially represent significant improvements over current therapi…
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February 9, 2007
Gilead Sciences and Achillion Pharmaceuticals have discontinued the development of GS 9132, also known as ACH-806, for the treatment of hepatitis C viral (HCV) infection. Preliminary data from the Phase Ib/II trial indicated that the compound demonst…
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February 7, 2007
Biogen Idec has initiated a randomized, controlled, registration trial of an investigational anti-CD23 monoclonal antibody, lumiliximab, for patients with chronic lymphocytic leukemia (CLL). The trial will compare treatment with lumiliximab in combin…
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January 29, 2007
GlaxoSmithKline's new generation H5N1 split antigen pre-pandemic flu vaccine has been accepted for review by the Committee for Medicinal Products for Human Use (CHMP) in Europe. This vaccine utilizes GSK's proprietary adjuvant system technology, whic…
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January 17, 2007
Shire received approval from the FDA for Lialda (mesalamine) with MMX technology, indicated for patients with active mild-to-moderate ulcerative colitis. Lialda is the only FDA-approved once-daily oral formulation of mesalamine. Shire will launch the…
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January 15, 2007
Ipsen's NDA for Somatuline Autogel (60, 90, 120 mg), a 28-day sustained-release formulation to treat patients with acromegaly, has been accepted by the FDA. This acceptance initiates the start of the review process of the NDA with a "prescriptio…
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January 5, 2007
Enzon Pharmaceuticals, Inc. has submitted an IND to the FDA for its HIF-1alpha (hypoxia-inducible factor 1alpha) antagonist, a highly visible, validated target in many cancer types, including solid tumors.
"2006 was a very exciting year for…
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January 2, 2007
Daiichi Sankyo, Inc. has filed an sNDA with the FDA for WelChol to improve glycemic control in patients with type 2 diabetes mellitus. If approved, WelChol would be the first LDL cholesterol-lowering drug that also improves glycemic control.
Wel…
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January 2, 2007
Ranbaxy Laboratories has received approval from the FDA to manufacture and market Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg. The Office of Generic Drugs, U.S. FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same the…
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December 27, 2006
Merck and Vertex Pharmaceuticals, Inc. began an international Phase II trial of MK-0457 (also known as VX-680), a small molecule inhibitor of Aurora, FLT-3, JAK-2 and BCR-ABL kinases. The study will be conducted in patients with treatment-resistant c…
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December 12, 2006
Millennium Pharmaceuticals reported overall response rates (ORR) as high as 75% from Phase II trials of Velcade for Injection combination therapy across four subtypes of non-Hodgkin's lymphoma (NHL): follicular, marginal zone, mantle cell lymphoma (M…
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November 29, 2006
Millennium Pharmaceuticals, Inc. initiated a randomized, double-blind, placebo-controlled Phase II study of MLN3897 in patients with rheumatoid arthritis (RA). MLN3897, an oral, small molecule designed to block CCR1, is a chemokine receptor believed…
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November 27, 2006
Genzyme Corp. has begun treating patients in a Phase II trial examining the safety and effectiveness of Clolar in previously untreated, older adult patients with acute myelogenous leukemia (AML) who are unlikely to benefit from standard induction the…
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