Trials & Filings
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April 4, 2006
Centocor, Inc.'s sBLA for Remicade for the treatment of pediatric Crohn's disease has been accepted and designated for Priority Review by the FDA. Centocor is seeking approval for the treatment of moderately to severely active pediatric Crohn's disea…
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April 3, 2006
Merck KGaA has been granted marketing authorization by the European Commission to extend the use of Erbitux in combination with radiotherapy, to treat patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Erbitux will b…
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March 31, 2006
Genentech and Biogen Idec have submitted an sBLA to the FDA for the use of Rituxan as first-line treatment of previously-untreated patients with low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with CVP (cyclophosp…
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March 31, 2006
Amgen has completed the BLA submission to the FDA for panitumumab for the treatment of metastatic colorectal cancer in patients who have failed prior chemotherapy, including oxaliplatin and/or irinotecan containing regimens. The rolling BLA submissio…
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March 29, 2006
GenVec, Inc. has begun a Phase II study to evaluate the anticancer activity of TNFerade in patients with metastatic melanoma. The open-label, single-arm, multi-center study will assess tumor response after four weeks of intratumoral injections of TNF…
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March 27, 2006
BioBalance Corp., a wholly owned subsidiary of New York Health Care, has received approval from the FDA to begin U.S. trials of its proprietary biotherapeutic agent, Probactrix, a prescription drug for pouchitis. Pouchitis is a debilitating complica…
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March 27, 2006
Amgen has received approval from the FDA for extended, every-three-week, dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. Aranesp is the only erythropoiesis-stimulating agent approved by th…
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March 9, 2006
Centocor, Inc. and Schering-Plough Corp. have been granted approval from the European Commission for Remicade for the treatment of moderate to severe, active ulcerative colitis (UC) in patients who have had an inadequate response to conventional ther…
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March 6, 2006
Tibotec Pharmaceuticals Ltd.'s NDA for TMC114, an investigational HIV protease inhibitor, has been accepted for priority review by the FDA. The goal date for the NDA will be June 23, 2006.
The NDA is based on the efficacy and safety results of t…
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March 6, 2006
Millennium Pharmaceuticals and co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) have initiated a three-arm, randomized, Phase II study of Velcade and pemetrexed in patients with locally advan…
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March 3, 2006
Celgene Corp.'s sNDA for Revlimid, for the treatment of relapsed or refractory multiple myeloma, has been granted a Priority Review designation by the FDA. The company is seeking approval to market Revlimid in combination with dexamethasone as a prop…
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March 2, 2006
ImClone Systems and Bristol-Myers Squibb received approval from the FDA for Erbitux for use in the treatment of squamous cell carcinoma of the head and neck. Designed to inhibit the function of the epidermal growth factor receptor (EGFR)—a mole…
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March 2, 2006
UCB has submitted a BLA to the FDA for the approval of Cimzia for the treatment of Crohn's disease. If approved, Cimzia would be the first-ever biologic utilizing subcutaneous injection for the treatment of Crohn's disease.
The BLA includes safe…
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March 1, 2006
Genentech and Biogen Idec received approval from the FDA for the therapeutic antibody Rituxan in combination with methotrexate (MTX) to reduce signs and symptoms in adult patients with moderate-to-severe rheumatoid arthritis (RA) who have had an inad…
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February 27, 2006
Peregrine Pharmaceuticals has achieved positive results demonstrating that its first-in-class anti-viral compound Tarvacin Anti-Viral appeared safe and well-tolerated in a Phase I study in chronic hepatitis C virus (HCV) infected patients. The data w…
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