Trials & Filings
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November 17, 2006
Genentech received approval from the FDA for Herceptin, a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel, for the adjuvant treatment of HER2-positive node-positive breast cancer. Adjuvant therapy is given to women with ear…
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November 14, 2006
Abbott received approval for an expanded indication for Humira that includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis (PsA). Humira is also approved in the U.S. for use in moderate to sev…
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November 14, 2006
CuraGen Corp. and TopoTarget have initiated patient dosing in a Phase II trial evaluating the antitumor activity of intravenous PXD101, a small molecule histone deacetylase (HDAC) inhibitor, for the treatment of ovarian cancer. The National Cancer In…
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November 13, 2006
Neurogen Corp. has begun a Phase I trial for its leading drug candidate for treatment of obesity. The compound, NGD-4715, works as an antagonist at the melanin concentrating hormone receptor-1 (MCH1).
William H. Koster, president and chief executiv…
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November 13, 2006
Cangene Corp.’s Varicella zoster immune globulin (VariZIG) has received orphan drug designation from the FDA for passive immunization for the treatment of exposed, susceptible individuals who are at risk of complications from varicella. This de…
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October 30, 2006
Albany Molecular Research, Inc. (AMRI) has selected a compound from its proprietary oncology research program for advanced preclinical testing, with the goal of submitting an Investigational New Drug Application (IND) to the FDA in 2007.
AMRI's dr…
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October 30, 2006
Emisphere Technologies has produced results from its 90-day, Phase II study of oral insulin product utilizing its eligen oral delivery technology. The four-arm study evaluated the safety and efficacy of low and high fixed doses of oral insulin tablet…
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October 23, 2006
AstraZeneca received approval from the FDA for Seroquel for the treatment of patients with depressive episodes associated with bipolar disorder. Seroquel was previously approved for the treatment of acute manic episodes associated with bipolar I diso…
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October 18, 2006
Merck received approval from the FDA for Januvia for the treatment of type 2 diabetes. Januvia has been approved as monotherapy and as add-on therapy to either metformin or thiazolidinediones (TZDs), to improve blood sugar control in patients with ty…
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October 16, 2006
Eisai and Pfizer received FDA approval for an sNDA for Aricept for the treatment of severe Alzheimer's disease (AD). With this approval, Aricept becomes the only prescription medication to treat mild, moderate and severe AD. Aricept, which is co-prom…
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October 13, 2006
Roche has initiated the first Phase II study to evaluate R1626, an investigational polymerase inhibitor, for the treatment of chronic hepatitis C. The drug has also been granted Fast Track designation by the FDA.
R1626 uses a different mechanism…
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October 12, 2006
Genentech received approval from the FDA for Avastin to be used in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small…
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October 11, 2006
The FDA has approved Merck's Zolinza capsules for the treatment of cutaneous T-cell lymphoma (CTCL), a type of skin cancer, to be used when the disease persists, gets worse, or comes back during or after treatment with other medicines. Zolinza is man…
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October 6, 2006
Wyeth Pharmaceuticals has submitted an NDA to the FDA and a marketing authorization application (MAA) to the EMEA for Torisel for the treatment of patients with advanced renal cell carcinoma (RCC).
The registration dossier contains interim data…
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October 5, 2006
Curis, Inc. and Genentech have filed an IND application with the FDA to initiate Phase I testing of a systemically administered small molecule Hedgehog antagonist for the treatment of cancer.
Under the terms of the June 2003 collaboration agreeme…
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