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Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.
Leading the news...
Six Genes May Help Predict Paclitaxel's Effectiveness In Cancer Patients.
According to research published in The Lancet Oncology, "Scientists have developed a gene test which predicts how well chemotherapy will work in cancer patients." In a study of "829 genes in breast cancer cells," researchers "whittled down the possibilities to six genes which had an impact on whether a drug worked." The study "showed that these genes could be used to predict the effectiveness of paclitaxel in patients."
Researchers found that "if any of the six genes are 'faulty,' paclitaxel does not work and the tumor cells continue to divide uncontrollably, just as they would without treatment," The lead researcher Dr Charles Swanton, from the Cancer Research UK charity's London Research Institute, said that the "research shows it is now possible to rapidly pinpoint genes which prevent cancer cells from being destroyed by anti-cancer drugs and use these same genes to predict which patients will benefit from specific types of treatment."
"Painless" Vaccine Delivery Method Introduced In Japan.
Japanese researchers have unveiled a "painless new vaccine delivery system" consisting of "as many as 300 micro needles" that do not need to penetrate the dermis layer of skin. Professor Kanji Takada, of Kyoto Pharmaceutical University, said the "patient feels no discomfort and there is no bleeding”. It is hoped that the use of the microneedles, which dissolve after being pressed into the skin, will help alleviate some patient's fear of getting shots.
Scientists Say TB, Antiretroviral therapy should be administered concurrently to co-infected patients.
Clinicians with patients who have both HIV and tuberculosis infections should not defer antiretroviral therapy until TB treatment has been completed. In fact, the "benefit of concomitant treatment was so striking that a data safety monitoring committee stopped the sequential arm of the study within two months of completion of enrollment," according to researchers in South Africa. The findings published in the New England Journal of Medicine add "weight to World Health Organization guidelines," which favor "integrated therapy."
Genentech Says Avastin Failed To Extend Survival Of Patients With Advanced Stomach Cancer.
Genentech reported that the combination of its blockbuster cancer drug Avastin [bevacizumab] and Xeloda [capecitabine] did not meet a late-stage goal of extending the lives of advanced stomach cancer patients." Genentech "said it will submit the data and hopes to present full results...at the 2010 American Society of Clinical Oncology's annual meeting." But, Genentech pointed out that the study did not reveal any new safety issues with Avastin.
Impax Receives FDA Approval For Generic Flomax.
Drugmaker Impax Laboratories Inc. reported that the Food and Drug Administration gave final approval to its generic version of the enlarged prostate treatment Flomax [tamsulosin hydrochloride]." The company "plans to start shipping the drug immediately." Impax "said it had reached a legal settlement last October with Astellas Pharma Inc. and Boehringer Ingelheim Pharmaceuticals Inc." to launch its generic version.
FDA Rejects Ranbaxy's Generic Flomax.
Daiichi Sankyo Co., which controls 64 percent of Ranbaxy Laboratories Ltd., reported that the " FDA rejected its Indian unit's application for approval to sell the generic version of Flomax. The company was expected to launch its generic version March 2 under a patent settlement.
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