FDA does not approve Ofirmev due to manufacturing site issues.
Reuter’s reported, "A pain and fever drug," called Ofirmev (intravenous acetaminophen), "being developed by Cadence Pharmaceuticals was not approved by federal regulators because of manufacturing problems at a facility where the drug is made, the company said Thursday." The FDA said it will not approve the drug until the issues are resolved. "Cadence said the FDA inspected a third party manufacturing facility on Friday," and the company "plans to meet with the FDA to make sure the problems have been addressed." It is stated further that, the FDA did not cite any safety or efficacy issues for the drug or require any additional studies to be conducted prior to approval.
FDA approves heat-stable version of Norvir.
Abbott Laboratories reported that it received Food and Drug Administration approval for a heat-stable version of the HIV treatment Norvir [ritonavir]." The approval is for a new formulation of the drug that "allows it to be stored at room temperature rather than in a refrigerator."
Taspoglutide may reduce sugar levels when compared with or added to other treatments.
Roche Holding AG declared results from five late-stage clinical trials show that its experimental diabetes drug taspoglutide reduced blood sugar levels when compared with or added to widely prescribed treatments." Roche said in a statement that the drug met the main goal of studies comparing it to Lantus (insulin glargine injection), Byetta (exenatide injection) and Januvia (sitagliptin), as well as trials where it was combined with metformin and against placebo. Additionally, taspoglutide was found to be generally well tolerated in all five trials, and the most frequently reported side effects were nausea and vomiting.
Few women taking tamoxifen for breast cancer prevention.
A study, appearing in the February 2010 edition of Cancer Epidemiology, Biomarkers & Prevention,Gardner) reported that, "despite the fact that experts have known since 1998 that tamoxifen can cut the risk of developing breast cancer by almost 50 percent," a recent study found that "only a tiny fraction of women at high risk of developing breast cancer take tamoxifen to prevent the disease." Looking at data on about 10,000 women from 2000 and 2005,. Researchers found that "only about 0.2 percent of US women aged 40 to 79 took tamoxifen to prevent breast cancer" in 2000. "In 2005, the prevalence was even lower -- only 0.08 percent." Researchers "did not say specifically how many of the women taking tamoxifen were at high risk for breast tumors."
Tamoxifen use linked to lower cognitive test scores.
According to a study appearing in the February Journal of Clinical Oncology, tamoxifen appears to affect cognitive abilities, including some types of memory. After a year of taking tamoxifen (Nolvadex), women in the study scored lower on tests of verbal memory functioning and other cognitive skills than did women taking another breast cancer drug, exemestane (Aromasin). Still, researchers "emphasized that it's important to keep the study results in perspective, noting the life-saving benefits of tamoxifen.
Statin users may continue to suffer muscle pains long after stopping the drugs.
According to a study published in the New England Journal of Medicine. Researchers found that patients experiencing muscle pain and weakness as a result of statin treatment may continue to suffer symptoms long after stopping the drugs. Nearly a third of patients who stopped statin treatment because of neuromuscular symptoms still showed myalgia six months later, and creatine kinase levels above 200 units/L persisted in 17%. The researchers suggested that creatine kinase measurements at the start of statin therapy could help identify patients with underlying neuromuscular diseases."
Twice weekly etanercept may provide benefits for skin but not joints.
According to a study published Feb. 2 in the BMJ, "twice weekly treatment with 50 mg of etanercept appears to be superior to once weekly treatment for the clearance of skin lesions in patients with psoriasis and psoriatic arthritis," but "there was no significant difference between the two etanercept regimens in the treatment of joint symptoms." Researchers arrived at those conclusions after studying "752 patients with both psoriasis and psoriatic arthritis who were randomly assigned to receive etanercept 50 mg twice weekly (n=379) or 50 mg once weekly (n=373) for 12 weeks by subcutaneous injection."
Also at http://www.pharm-education.com/2010/02/clinical-research-updates-on-new-drugs.html
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