Trials & Filings
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June 9, 2006
Merck received FDA approval for Gardasil, a vaccine designed to prevent cervical cancer by blocking infection from human papillomavirus (HPV), the most common sexually transmitted disease. The vaccine targets four strains of HPV, two of which are res…
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June 9, 2006
Merck/Schering-Plough Pharmaceuticals received FDA approval for Zetia for use, along with diet, in combination with fenofibrate for the reduction of elevated total cholesterol and LDL "bad" cholesterol in patients with mixed hyperlipidemia,…
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June 8, 2006
Merck's NDA for Zolinza for the treatment of advanced cutaneous T-cell-lymphoma (CTCL) has been granted priority review by the FDA. A priority review designation is intended for products that address unmet medical needs. Under the Prescription Drug U…
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June 7, 2006
Abbott received approval from the European Commission to market Humira as a treatment for severe, active ankylosing spondylitis (AS) in Europe. AS is a chronic disease of the axial skeleton and large peripheral joints that causes inflammatory back pa…
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May 31, 2006
Sandoz has been granted approval by the FDA for its recombinant human growth hormone Omnitrope as the first follow-on version of a previously approved recombinant biotechnology drug. Omnitrope is indicated for treatment of growth disorders in childre…
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May 30, 2006
CuraGen Corp. has initiated patient dosing in a Phase II trial evaluating a single dose of velafermin for the prevention of oral mucositis (OM). This is the second Phase II study of velafermin and is designed to assess the safety and efficacy of vela…
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May 26, 2006
The FDA has approved Merck's vaccine Zostavax for prevention of herpes zoster (shingles) in individuals 60 years of age and older. Shingles is a frequently painful disease marked by a blistering rash. Caused by the reactivation of the virus that caus…
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May 24, 2006
Genmab has initiated a Phase III study with HuMax-CD20 to treat patients with refractory B-cell Chronic Lymphocytic Leukemia (CLL). HuMax-CD20 received a Fast Track designation from the FDA in December 2004 for this indication.
The study will in…
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May 22, 2006
Centocor, Inc. has received approval from the FDA for Remicade for reducing signs and symptoms and inducing clinical remission in pediatric patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conven…
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May 19, 2006
An FDA advisory committee voted 13 to 0 to endorse Merck vaccine, Gardasil, which blocks a sexually transmitted virus that causes cervical cancer. U.S. advisers unanimously said it was safe and effective for women and girls as young as 9 years old. T…
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May 19, 2006
Bristol-Myers Squibb has discontinued the development of muraglitazar, a dual alpha/gamma PPAR (peroxisome proliferator-activated receptor) agonist in development for type 2 diabetes and will focus its efforts on other priority portfolio projects.…
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May 18, 2006
DeCODE Genetics initiated patient enrollment in the pivotal Phase III trial for DG031, the company's lead developmental compound for the prevention of heart attack.
The multicenter Phase III trial will be randomized, double-blind, placebo- contro…
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May 16, 2006
Manhattan Pharmaceuticals received Swiss regulatory approval to begin its Phase IIa study with oral Oleoyl-estrone (OE), the company's drug candidate for the treatment of obesity. The single center, Phase IIa study is a randomized, double-blind, plac…
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May 16, 2006
BioMS Medical Corp. has received regulatory approval to initiate a Phase II trial to investigate the efficacy and safety of MBP8298 in patients with relapsing-remitting multiple sclerosis (RRMS) in the first of several European countries. Patient enr…
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May 15, 2006
EntreMed, Inc. has initiated a Phase II trial to evaluate the safety and efficacy of its lead clinical-stage drug candidate, Panzem NCD, in combination with Avastin in patients with locally advanced or metastatic carcinoid tumors. The study will be c…
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