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Yale And Tsinghua University To Develop Healthcare Leadership In China
As part of its continuing engagement in global health issues, Yale University"s Global Health Leadership Institute is partnering with Tsinghua University to launch a four-year leadership development program in healthcare management for women in China. The effort is part of the 10,000 Women initiative, a program launched by Goldman Sachs to provide business and management education to women around the world. The program is based on research from Goldman Sachs, the World Bank, and others which found that investments in women can lead to significant economic and social returns.
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Charities Launch Groundbreaking Research Cancer Centre In Newcastle, England
The opening of a unique centre will put Newcastle at the forefront of cancer research and bring benefits to patients in the North East.
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Ohio Supreme Court Restricts Mifepristone Use In State To Scope Of FDA's Approval Letter
In answering two certified questions from the U.S. Court of Appeals for the 6th Circuit, the Ohio State Supreme Court on July 1 declared that a state law regulating the use of mifepristone -- which is used in medication abortion -- bars physicians from prescribing it for off-label use, BNA reports. The court confirmed that doctors who use the drug to induce abortion must do so in compliance with the 49-day gestational limit included in FDA"s 2000 drug approval letter. Doctors also must prescribe the drug in accordance with the protocols and dosage indications included in its FDA-approved labeling.Interpretation of State Law in ContentionThe Ohio General Assembly in 2004 passed a law (Section 2919.123 (A)) that required any health care professional prescribing or dispensing mifepristone to comply with "all provisions of federal law that govern the use" of the drug. The law defines "federal law" as "any law, rule or regulation of the United States or any drug approval letter" from FDA "that governs or regulates the use of" mifepristone for inducing abortion. FDA"s approval letter states that the drug "is indicated for use in the termination of pregnancy (through 49 days" pregnancy) and has no other approved indication for use during pregnancy." In addition, the drug"s label states the recommended dosage and that its use requires three office visits by the patient. Planned Parenthood Southwest Ohio Region challenged the law in district court, arguing that neither FDA"s approval letter nor any other federal provision bans the off-label use of mifespristone to induce abortion beyond 49 days" gestation. The group also argued that the state law was unconstitutionally vague because it did not notify abortion providers in advance regarding which FDA documents were included in the state"s criminal law. In addition, Planned Parenthood said that prohibiting the evidence-based use of the drug would infringe on the rights of women, requiring them to take higher-than-necessary dosages of the drug or to undergo surgical abortions when a noninvasive alternative is available. The district court ruled in favor of Planned Parenthood, saying that the law was void because of vagueness. The state appealed the decision to the 6th Circuit, which then submitted two questions to the state Supreme Court seeking its interpretation of the law.The state Supreme Court ruled that FDA"s drug approval letter is included in the definition of "federal law" and that the state law is not ambiguous, according to BNA. The court said that because the drug approval letter incorporated FDA"s labeling text, Ohio physicians cannot prescribe or provide mifepristone to induce abortion outside of the stipulations of the drug approval letter and approved label. According to BNA, product liability law experts say the ruling will not have an impact outside of mifepristone or the state of Ohio.Case Returns to Appeals CourtRoger Evans of Planned Parenthood Federation of America said that he is not sure if the court"s decision helps or hurts the group"s case. Evans said that the district court declared the law unconstitutional based on an interpretation that the statute operates in the same way the state Supreme Court ruled it does. He noted that there are other possible interpretations of the law that would have solved the constitutional issues at the center of the litigation. However, because those issues were not resolved, the case now returns to the 6th Circuit, which will decide if the statute is constitutional based on the state Supreme Court"s interpretation. If the circuit court agrees with the district court that the statute is unconstitutionally vague, the state of Ohio could seek a U.S. Supreme Court review. If the circuit court finds that the statute is constitutional, the case likely will be sent back to the district court for resolution of some other issues in the case, according to BNA (BNA, 7/6).
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Abbott And AstraZeneca Submit New Drug Application To The FDA For CERTRIAD(TM), An Investigational Treatment For Mixed Dyslipidemia

Abbott (NYSE: ABT) and AstraZeneca announced that the companies have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational compound for the treatment of mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL- cholesterol (the "bad" cholesterol), high triglycerides and low HDL-cholesterol (the "good" cholesterol). The NDA submission for this investigational compound, containing the active ingredients of CRESTOR(R) (rosuvastatin calcium) and TRILIPIX(R) (fenofibric acid), is supported by data from multiple studies, including efficacy and safety studies with the 5mg, 10mg and 20mg doses of rosuvastatin combined with fenofibric acid. Pending approval of the NDA, the treatment will be marketed as CERTRIAD(TM). "The NDA submission is an important milestone in the development of CERTRIAD and demonstrates our commitment to developing treatments for dyslipidemia," said Howard Hutchinson, chief medical officer, AstraZeneca. "We look forward to continued discussions with the FDA about this potential new medicine." "Patients with mixed dyslipidemia are an underserved segment of the dyslipidemic population," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "If approved, CERTRIAD could become an important treatment option for physicians looking to provide comprehensive management of mixed dyslipidemia to their patients." According to the American Heart Association, more than 100 million adults in the United States have dyslipidemia. Of those, approximately 34 million people are affected by mixed dyslipidemia. Treatment guidelines endorsed by the National Cholesterol Education Program (NCEP), the American College of Cardiology and the American Heart Association have called for more aggressive management of lipids, including a lower LDL goal for many patients, as well as more aggressive management of HDL and triglycerides. About CERTRIAD(TM) CERTRIAD is an investigational compound containing the active ingredients of CRESTOR and TRILIPIX under development by Abbott and AstraZeneca for the treatment of mixed dyslipidemia. Phase III studies, which have been presented at multiple scientific forums, were designed to evaluate the effect of CERTRIAD on HDL and triglycerides compared to rosuvastatin monotherapy and the effect on LDL compared to fenofibric acid monotherapy in patients with mixed dyslipidemia. About CRESTOR CRESTOR is indicated as adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia, and to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. CRESTOR is not approved to reduce cardiovascular morbidity and mortality. For patients with hyperlipidemia and mixed dyslipidemia, the usual recommended starting dose of CRESTOR is 10 mg. The 40-mg dose of CRESTOR is reserved only for those patients who have not achieved their LDL-C goal utilizing the 20-mg dose of CRESTOR once daily. When initiating statin therapy or switching from another statin therapy, the appropriate CRESTOR starting dose should first be utilized, and only then titrated according to the patient"s individualized goal of therapy. Important Safety Information CRESTOR is contraindicated in patients with a known hypersensitivity to any component of this product and in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, in women who are or may become pregnant, and in nursing mothers. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with drugs in this class, including CRESTOR. These risks can occur at any dose level but are increased at the highest dose (40 mg). The risk of myopathy during treatment with CRESTOR may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, or lopinavir/ritonavir. Combination therapy with rosuvastatin and gemfibrozil should be avoided. CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, advanced age, and inadequately treated hypothyroidism. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. It is recommended that liver enzyme tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. The most frequent adverse reactions thought to be related to CRESTOR were headache (3.7%), myalgia (3.1%), abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%).(1,2) About TRILIPIX TRILIPIX (fenofibric acid) delayed-release capsules is a prescription medicine used along with a low-fat and low-cholesterol diet in adults to lower triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol. TRILIPIX can be used alone. It can also be used to lower triglycerides and increase HDL cholesterol in patients with heart disease or who are at risk of heart disease and who are taking a statin medicine to control their LDL cholesterol. TRILIPIX has not been shown to prevent heart disease or heart attacks or stroke more than a statin alone. Important Safety Information About TRILIPIX TRILIPIX should not be taken by people with liver, gallbladder, or severe kidney disease, nursing mothers, or those allergic to any product ingredient. Unexplained muscle pain, tenderness, or weakness, particularly when occurring with tiredness and fever, may be a sign of a serious side effect and should be reported to a healthcare provider right away. Rarely, muscle-related problems can cause kidney damage and can be fatal. The risk of these side effects may be increased when TRILIPIX is used with a statin. Patients should tell their healthcare provider about all the medicines they take to help avoid serious side effects. Blood tests may be performed before and during treatment with TRILIPIX to check for liver or kidney problems. Patients should contact their healthcare provider if they experience abdominal pain, nausea, or vomiting while taking TRILIPIX. These may be signs of inflammation of the gallbladder or pancreas. Women who are pregnant should not take statins and should talk with their healthcare provider about TRILIPIX if they are pregnant or may become pregnant. The most common side effects with TRILIPIX include headache, heartburn, nausea, muscle aches, and increases in muscle or liver enzymes that are measured by blood tests. About AstraZeneca AstraZeneca is engaged in the research, development, manufacturing, and marketing of meaningful prescription medicines and in the supply of health care services. AstraZeneca is one of the world"s leading pharmaceutical companies with global health care sales of $31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology, and infectious disease medicines. In the United States, AstraZeneca is a $13.5 billion dollar health care business. About Abbott Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries. AstraZeneca


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