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Journal Of Clinical Oncology Publishes Study Demonstrating Improvement In Overall Response And Progression-Free Survival-Chronic Lymphocytic Leukemia
Cephalon, Inc. (Nasdaq: CEPH) announced yesterday that the Journal of Clinical Oncology has published data from a pivotal phase 3 study demonstrating that TREANDA® (bendamustine HCl) for Injection improved clinical outcomes when compared to chlorambucil in patients with chronic lymphocytic leukemia (CLL). Results of this study were the basis of the March 2008 U.S. Food and Drug Administration (FDA) approval of TREANDA for CLL, the first agent approved by the FDA for this disease since 2001. According to the American Cancer Society, there will be more than 15,000 new cases of CLL diagnosed in 2009 alone. The study results were published online today and will also appear in the print edition later this year.
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U-M Study: Why Dishing Does You Good
A University of Michigan study has identified a likely reason: feeling emotionally close to a friend increases levels of the hormone progesterone, helping to boost well-being and reduce anxiety and stress.
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Studies Examine Morning Sickness Drug, Progesterone Use To Prevent Premature Birth
The following summarizes news coverage on two pregnancy-related studies. ~ Morning sickness: The commonly prescribed heartburn drug metoclopramide -- sold generically and under the brand-names Reglan, Octamide and Maxolon -- can be used to treat morning sickness without harming the health of the fetus, according to a study published on Thursday in the New England Journal of Medicine, Time reports. The drug, which also has anti-nausea properties, is not FDA-approved for use in pregnant women in the U.S., though it is commonly prescribed in European and other countries to treat morning sickness (Park, Time, 6/10). According to the Los Angeles Times, U.S. physicians occasionally prescribe metoclopramide to treat severe morning sickness cases. The new study found that there were no statistically significant differences between infants born to women who took metoclopramide and those who did not. Researchers said that the findings "provide reassurance regarding the safety of metoclopramide for the fetus when the drug is given to women to relieve nausea and vomiting during pregnancy." The study involved 81,703 births among women enrolled in Israel"s largest health HMO, including 33,458 who used the drug (Maugh, Los Angeles Times, 6/11). Jennifer Niebyl, a professor of obstetrics and gynecology at the University of Iowa, said, "There are very few drugs approved for use in the first trimester of pregnancy. But this study could lead to metoclopramide getting approved to treat morning sickness because this is good data with big numbers" (Time, 6/10).~ Progesterone: The hormone progesterone was not effective at preventing premature births among women pregnant with twins, despite evidence suggesting its effectiveness at preventing premature births in single pregnancies, according to a University of Edinburgh study published in the journal Lancet, Reuters reports. Multiple pregnancies have a larger health risk for women and significantly increase the likelihood of miscarriage, premature birth and long-term health problems. The study involved 500 women who took either progesterone or a placebo daily for 10 weeks. Although previous studies have shown that progesterone might prevent premature birth in certain high-risk pregnancies, the new findings show the treatment did not reduce the likelihood of premature delivery or a fetus dying in utero in twin pregnancies. Twenty-five percent of women delivered or had a fetus die before 34 weeks in the progesterone group, compared with 20% in the placebo group (Kahn, Reuters, 6/10).
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Paladin Labs Announces Canadian Launch Of Twinject(R) TwinpackTM For Anaphylaxis

Good news for the 1.3 million Canadian patients at risk for anaphylaxis, as Paladin Labs Inc. (TSX:PLB), a leading Canadian specialty pharmaceutical company, announced the Canadian launch of Twinject® TwinpackTM, making it more convenient for people to manage this potentially life threatening condition. Twinject® TwinpackTM includes two Twinject® epinephrine auto-injectors, allowing patients to store an auto-injector in multiple key locations such as home or work, while carrying another device with them at all times. The TwinpackTM also includes a Twinject® demonstrator that helps patients and family members practice using the auto-injector so they feel more confident in an emergency anaphylactic situation. "It"s vital for individuals at risk for anaphylaxis to be prepared for an emergency", says Laurie Harada, Executive Director, Anaphylaxis Canada. This requires having an auto-injector with them at all times and making sure they and others, such as friends, family members, and caregivers, are comfortable using the device. The demonstrator provides an important hands-on teaching tool." The need for effective anaphylaxis management is clear, with published studies demonstrating that fewer than 30 per cent of patients carry their epinephrine auto-injectors with them at all times(1). In addition, a recent survey shows that 39 per cent to 50 per cent of food-induced anaphylactic reactions in children occurred outside the home(2). "We are excited to launch the Twinject® TwinpackTM as it addresses the needs of anaphylactic patients. As such, the Twinject® TwinpackTM will provide superior protection for patients and ensure that they are adequately trained and prepared in an anaphylactic situation," said Mark Beaudet, Vice President Sales and Marketing of Paladin Labs. Twinject® is a novel epinephrine auto-injector indicated for the emergency treatment of severe allergic reactions (anaphylaxis). Twinject® TwinpackTM is available in two dosages (0.3 mg and 0.15 mg) for self-administration. About Anaphylaxis Anaphylaxis is a severe, life-threatening systemic allergic reaction triggered by exposure to one or more various antigens, including foods, insect stings, drugs, and latex products. Up to eight percent of children have food allergies, with allergies to peanuts and tree nuts among children having doubled in the past five years. The timing, location, pattern (including onset, severity and length) and specific treatment requirements for each future anaphylactic episode cannot be predicted in advance. It is estimated by Anaphylaxis Canada that there are over 1.3 million Canadians at risk for anaphylaxis. About Twinject® Twinject® is a pre-filled, pen size auto-injector with two doses of epinephrine for the emergency treatment of severe allergic reactions (anaphylaxis). The first dose is administered using the auto-injector. The second dose, if needed, is administered via a pre-filled syringe located inside the barrel of the device. Twinject® is available in a compact, crush-resistant carrying case, with instructions for use attached to the device. In addition, a consumer campaign called Twinject® BeReady, is available to provide comprehensive patient training and support. For more information about Twinject®, please visit http://www.twinject.ca. (1) Goldberg A, Confino-Cohen R. J Allergy Clin Immunol 2000;106(6):1184-1189 (2) Jarvinen KM, et al. J Allergy Clin Immunol 2008;122(1):133-138 Paladin Labs Inc.


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