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2009 NOV 30 ... well tolerated in the study and no patients on XR-NTX discontinued the study due to adverse events. The most common adverse events experienced by patients receiving XR-NTX during ... on the positive results of this phase 3 study, Alkermes plans to file a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) in the first half of ... with active liver disease must be carefully considered in light of its hepatotoxic effects. The margin of separation between the apparently safe dose of naltrexone and the dose ...
2009 NOV 30 ... of the patients assigned to get 20 mg/day had to discontinue or change their dose due to adverseeffects, compared to only 2 percent in the low-dose group and 7 percent in the ... Tailoring the dose of a heart failure drug to a patient's response is better than the one-size-fits-all approach, according to ...
2009 NOV 30 ... beta-1 receptors, which the Company believes is important because this potentially adverse signaling state is more prevalent in the Arg 389 beta-1 receptor variant. ... in response to the May 29, 2009 Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for ARCA's New Drug Application (NDA) seeking approval for ... molecules that would otherwise activate the receptor. Because of its mild vasodilator effects, the Company believes Gencaro is well-tolerated in patients with advanced HF. ...
2009 NOV 30 ... versus placebo, which were secondary endpoints. The most commonly reported adverse events (AEs) with flibanserin 100mg were mild to moderate and emerged during the first ... Regulatory Actions, Self-Esteem, Sexual Dysfunction, Therapy, Treatment, U.S. Food and Drug Administration, Women's Health This article was prepared by Biotech ... for the patient, may put a strain on relationships with partners, and is not due to the effects of a substance, including medications, or another medical condition. To ...
Subject: Boehringer Ingelheim Pharmaceuticals, Inc.
2009 NOV 30 ... G. Masi and colleagues. The researchers concluded: "She reported no severe adverseeffects." Masi and colleagues published their study in Nature Reviews ... Carcinoid Tumor, Chemotherapy, Cisplatin, Clinical Oncology, Doxorubicin Hydrochloride, Drug Therapy, Drugs, Etoposide, Neuroendocrine Tumors, Octreotide, Octreotide Therapy, ...
2009 NOV 30 ... the potential safety concern for an increased risk of stroke (11 yes to 1 no) or adverse cardiovascular events (11 yes with 1 abstention). This is consistent with the current ... The U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee voted 11 to 1 that ... include constipation and trouble passing urine. For a complete list of reported side effects, ask your doctor or pharmacist. Do not get SPIRIVA powder in your eyes. ...
2009 NOV 30 ... after using the benefit. Researchers also found that there were 12% fewer claims for adverse maternal birth complications since the benefit was implemented. The ... Disease, Quit Smoking, Regulatory Actions, Smoking Cessation, Tobacco Use, U.S. Food and Drug Administration, Partnership for Prevention. This article was prepared by ... and in the United States. More than 8,000 Massachusetts residents die annually from the effects of smoking, and tobacco use is associated with $4.3 billion in excess health care costs ...
2009 NOV 30 ... (muscle breakdown) associated with ZETIA; however myopathy and rhabdomyolysis are known adverse reactions to statins and other lipid-lowering drugs. There are no adequate and ... Schering-Plough Corporation, Simvastatin, Stroke, Therapy, Treatment, U.S. Food and Drug Administration, Vytorin, Zetia, Merck & Co. Inc. This article was prepared ... their appropriate patients." Both niacin and ezetimibe have established effects on lipids, as noted in the prescribing information for these medicines. We look forward ...
2009 NOV 30 ... vital signs, laboratory evaluations, electrocardiograms, blood pressure measurements and adverse event (AE) assessments. In the reversal phase of the study, eight weeks ... or atorvastatin 20 mg for an additional eight weeks. The effect of withdrawal of the drug on lipid efficacy (LDL-C, HDL-C, total cholesterol, non-HDL-C, apo B, apo A-1), CETP ... as monotherapy or co-administered with atorvastatin, there were persistent lipid effects in the higher dose arms in both the monotherapy and co-administration treatment groups ...
2009 NOV 30 ... as warranted by the return of pain. In clinical trials, the most common adverse reactions were application site redness, pain, itching, and papules. The majority of ... NeurogesX, Inc. (NASDAQ:NGSX) announced that the U.S. Food and Drug Administration (FDA) has approved Qutenza™ (capsaicin) 8% patch, the first and ... patient's quality of life. Despite a variety of medications for pain, undesirable side effects often limit their use and therefore, the treatment of PHN continues to represent a ...
2009 NOV 30 ... used for alcoholism, the clinical utility of which is limited by poor efficacy and adverse side effects. Here, we demonstrate that the therapeutic limitations of naltrexone may ... these data provide insight into the limited actions of the clinically important drug naltrexone and identify a novel target with improved specificity and efficacy for the ...
2009 NOV 30 ... 4 mg (n = 1.04). The successful treatment of pruritus (no or mild pruritus) and other adverseeffects were determined 15 min after study drug administration, and patients were ...
2009 NOV 30 ... serve as key regulators of the nervous system to promote therapeutic effects and limit adverse side effects. Targacept has clinical-stage product candidates in development for major ... an approved treatment for MDD marketed in the United States as Celexa®, is from the drug class known as selective serotonin reuptake inhibitors. At the end of the eight weeks, ...
2009 NOV 30 ... and less severe with FOLPI. Most patients who decided to discontinue FOLFOX because of adverseeffects did so because of a Grade 1-3 neuropathy (7 patients on FOLFOX verses no ... overall survival data to facilitate an end of Phase 2 meeting with the U.S. Food and Drug Administration," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "Based on the ...
2009 NOV 30 ... to the control of disease. Namely the spread of drug resistance, data scarcity and the adverseeffects of failed elimination attempts. Mathematical models of various levels of ...
2009 NOV 30 ... three dropped out the study. More patients in the treatment arm had at least one related adverse event (94.4% versus 45.9%; p< 0.001); no other significant differences in safety ... London EC1Y 1SP, England. Keywords: City:Barcelona, Country:Spain, Adverse Drug Effect, Adverse Drug Event, Adverse Drug Reaction, Antiviral, Clinical Trial Research, ... primary progressive multiple sclerosis and transitional multiple sclerosis. Positive effects of interferon beta on secondary clinical and magnetic resonance imaging outcomes were ...
2009 NOV 30 ... tryptophan is the most susceptible protein residue involved in various photosensitized adverseeffects. Of these processes, the tryptophan photosensitization induced by methylene blue ... 'Role of aromatic amino acid tryptophan UVA-photoproducts in the determination of drug photosensitization mechanism: a comparison between methylene blue and naproxen.' "The ...
2009 NOV 30 ... and catecholamine production was significantly reduced. Except for mild nausea, adverseeffects were virtually absent. Bone marrow function, renal function, and serum ... Country:United States, Blood Pressure, Bone Marrow, Catecholamin, Chemotherapy, Drug Therapy, Drugs, Endocrinology, Gastroenterology, Hormones, Nausea, Neurology, ...
2009 NOV 30 ... were quality of life (Qolie-10) and complaints score. were the occurrence of seizures or adverse events. After 7 months, the relative risk (RR) for improvement in quality of life was ... researchers concluded: "Despite a possible risk of seizure recurrence, adjustment of drug treatment in well-managed patients with epilepsy, who report considerable complaints, ... "Complaints about side-effects of antiepileptic drugs (AEDs) may be overlooked in clinical practice. We assessed the ...
2009 NOV 30 ... at the meeting, showed that TB-403 demonstrated a good safety profile with no serious adverseeffects reported. Dr. Patrik De Haes, CEO of ThromboGenics, commented: "We ... Keywords: Angiogenesis, Biotechnology, Clinical Trial Research, Drug Development, Monoclonal Antibodies, Oncology, Pharmaceuticals, Solid Cancers, Solid ...
