Trials & Filings
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February 22, 2006
Pfizer has received approval from the FDA for Eraxis to treat candidemia, a potentially life-threatening bloodstream infection. Candidemia is the most deadly of the common hospital-acquired bloodstream infections, with a mortality rate of approximate…
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February 22, 2006
Schering-Plough's NDA for Noxafil Oral Suspension (for use in preventing serious invasive fungal infections (IFIs) in high-risk patients) has been granted a six-month priority review by the FDA. Priority review designation is granted to drugs that, i…
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February 21, 2006
Sanofi-Aventis has received an approvable letter from the FDA's Division of Metabolism and Endocrinology Products for rimonabant for weight management, and a non-approvable letter from the Division of Anesthesia, Analgesia and Rheumathology Products,…
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February 17, 2006
Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals, Inc. have initiated a randomized, double-blind, placebo-controlled Phase III trial studying Nexavar tablets administered in combination with the chemotherapeutic agents carboplatin and paclitaxel…
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February 16, 2006
The FDA has removed the hold on clinical trial dosing of Tysabri in multiple sclerosis (MS) in the U.S. Biogen Idec and Elan Corp. expect to begin an open label, multi-center safety extension study of Tysabri monotherapy in the U.S. and international…
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February 15, 2006
Merck's NDA for Januvia has been accepted for review by the FDA. Merck expects FDA action on the NDA by mid-October. The company also is moving forward with filings in countries outside the U.S.
Januvia is an investigational once-daily medicine…
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February 10, 2006
Merck's interim results from a dose-ranging Phase II trial of new integrase inhibitor MK-0518 showed that the oral drug -- at all three doses studied (200 mg, 400 mg, and 600 mg orally twice daily) in combination with optimized background therapy (OB…
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February 10, 2006
Gilead Sciences' results of a Phase I/II dose-escalation study of GS 9137, or JTK-303, a novel oral HIV integrase inhibitor, show significant reductions in viral load among HIV-positive patients receiving GS 9137 as monotherapy or in combination with…
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February 8, 2006
Adolor Corp. and GlaxoSmithKline achieved initial top-line results of the Phase III Study 14CL314 of Entereg for the management of postoperative ileus (POI), by acceleration of the time to recovery of gastrointestinal (GI) function following bowel re…
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February 7, 2006
Merck & Co.'s BLA for Gardasil, the investigational cervical cancer vaccine, has been accepted and granted priority review by the FDA. A priority designation is intended for products that address unmet medical needs. Under the Prescription Drug U…
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February 6, 2006
Merck & Co. has received FDA approval for Rotateq, the only vaccine available in the U.S. to prevent rotavirus gastroenteritis, a leading cause of severe diarrhea in infants and young children. Rotateq is an oral, three-dose vaccine given to infa…
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February 6, 2006
Isis Pharmaceuticals has initiated the development program of ISIS 301012 in patients with familial hypercholesterolemia (FH), a genetic disorder that causes extremely high cholesterol levels and results in the early onset of heart disease. ISIS 3010…
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February 3, 2006
Pfizer has been granted marketing authorization for Macugen for the treatment of neovascular (wet) age- related macular degeneration (AMD) by the European Commission. Macugen is the first treatment to target the underlying disease process and has bee…
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January 30, 2006
Pfizer received approval from the FDA for Exubera Inhalation Powder for the treatment of type 1 and type 2 diabetes in adults. Exubera was found in clinical trials to be as effective as short-acting insulin injections, and to significantly improve bl…
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January 18, 2006
Sanofi-Aventis and Bristol-Myers Squibb's sNDA for Plavix for treatment of patients with acute ST-segment elevation myocardial infarction (STEMI) has been accepted for review by the FDA. STEMI is a heart attack in which an artery is generally blocked…
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