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News From The American Journal Of Pathology, June 2009
Stromal Caveolin-1 Predicts Breast Cancer Prognosis
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Innovative Medicines Initiative: 246 Million Euros To Support Public-private Research Cooperation For A Fast Development Of Better Medicines
Today, 15 new research projects aimed at bringing innovative medicines more quickly to the market have been selected to receive 246 million euros from the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The projects will foster understanding of health issues such as diabetes, pain, severe asthma and psychiatric disorders while increasing drug safety. They will also help improve the training of researchers and clinicians involved in medicines development. The projects were chosen following the first call for proposals launched within the Innovative Medicines Initiative (IMI), a public-private partnership - so called Joint Technology Initiative- between the European Commission and the pharmaceutical industry. With this selection, IMI has reached a key milestone. This initiative marks the first time that pharmaceutical competitors are pooling their res, together with research organisations, patient groups and other stakeholders in large consortia, in order to develop generic, pre-competitive knowledge. The Commission"s contribution of €110 million is backed up with €136 million provided in-kind from the pharmaceutical industry. The successful projects will now enter into the final negotiation phase.
News of the day
Government-Run Screening Programs Might Lead To Overtreatment Of Breast Cancer, Danish Study Says
One in three breast cancer patients identified in certain nations" public screening programs might have undergone unnecessary treatment, according to a study published Friday in BMJ, the AP/Google.com reports. For the study, Karsten Jorgensen and Peter Gotzsche of Copenhagen"s Nordic Cochrane Centre examined breast cancer trends at least seven years before and after the launch of government-run screening programs in parts of Australia, Canada, Great Britain, Norway and Sweden. The programs usually test women ages 50 to 69.According to the AP/Google.com, effective screening programs should detect more cases and result in a decline in advanced cancer cases detected in older women, whose cancers would have been caught in earlier screenings. However, the study found that the national screening systems simply detected thousands more cases than previously identified.Experts say that overtreatment of cancer occurs wherever there are widespread screening programs, including in the U.S. Some cancers develop too slowly to ever cause symptoms or death, the AP/Google.com reports. However, it is impossible to determine which cancers will be deadly, so all detected cases are treated. Jorgensen said that there is "significant harm in making women cancer patients without good reason" and that the "information needs to get to women so they can make an informed choice."Gilbert Welch of the VA Outcomes Group and the Dartmouth Institute for Health Policy and Research wrote in an accompanying editorial that although mammography "undoubtedly helps some women," it "hurts others." Welch wrote that it is "one of medicine"s "close calls," ... where different people in the same situation might reasonably make different choices."Britain"s National Health Service recently stopped distributing breast cancer screening pamphlets in response to criticism that they included too little information on cancer overtreatment. Laura Bell of Cancer Research UK said that although the organization still urges women to be screened, it is important that they be made aware of potential benefits and harms (Cheng, AP/Google.com, 7/9).
Mental Health

FDA Approves Cambia™ For Migraine

Kowa Pharmaceuticals America, Inc. (KPA), a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. Food and Drug Administration (FDA) has approved Cambia™, a diclofenac-based non-steroidal anti-inflammatory drug ("NSAID") combined with potassium bicarbonate, for the treatment of acute migraine with or without aura in adults. Cambia™, formulated with KPA"s patented Dynamic Buffering Technology (DBT), was specifically developed to address widespread unmet needs among patients by offering fast and effective relief of migraine pain. In randomized clinical trials, Cambia™ was shown to be effective not only in migraine pain, but also in treating photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea commonly associated with migraine attacks. Cambia™ was also shown to provide statistically significant onset of relief of migraine pain within 15 to 30 minutes. "The approval is the culmination of over three years of effort from our partners at Applied Pharma Research and the internal team at Kowa," said William Maichle, Chief Operating Officer of Kowa Pharmaceuticals America, Inc. "Patients and physicians consistently mention rapid pain relief as most important when asked about primary attributes of a migraine medication. We believe Cambia™ addresses these needs and will be a valuable addition to physicians" migraine armamentarium." KPA obtained exclusive U.S. and Canadian marketing rights for Cambia™ from Applied Pharma Research (APR), a Swiss drug delivery and drug development company, in 2005. The product is currently marketed by Novartis Pharma AG, via a license from APR, under the trademarks Voltfast or Catafast in several European countries. KPA and APR have been granted patents that cover Cambia™ through 2026. KPA and APR are currently in the final stages of negotiations with a marketing partner and expect Cambia™ to launch in 4th quarter 2009. About Migraine Migraine headaches affect an estimated 30 million people in the United States and disproportionately affect women 3 to 1. According to a recent peer reviewed publication authored by leading migraine researchers, more than 70 percent of patients indicated that they were less than completely satisfied with their current treatment. Over 85 percent complained that pain relief took too long and 25 percent decided to stop seeking treatment altogether. Kowa Company Ltd. Kowa Pharmaceuticals America, Inc.


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