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CHMP Recommends Expanded Use Of ISENTRESS(R) (Raltegravir), From MSD, In Adult Patients With HIV-1 Infection
Merck Sharp & Dohme Limited (MSD) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending expanded marketing authorisation for "Isentress" (raltegravir) in combination with other antiretroviral (ARV) medicinal products for the treatment of HIV-1 infection in all appropriate adult patients, including patients starting HIV therapy for the first time (treatment-naç¯ve), as well as treatment-experienced patients. The positive opinion will be reviewed by the European Commission, which grants marketing authorisation to the 27 countries that are members of the European Union (EU), as well as Iceland and Norway.

Boehringer Ingelheim To Present New Phase II Clinical Data On Two Lead Oncology Compounds At ASCO 2009
Boehringer Ingelheim will present new data on the company"s two lead oncology compounds, BIBW 2992* and BIBF 1120** at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO), the company announced today. Two studies in the LUX-Lung clinical development programme for BIBW 2992 and a Phase II study of BIBF 1120 in ovarian cancer patients will be presented.
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PolyMedix Receives Regulatory Clearance To Initiate Second Phase I Clinical Study Of Novel Systemic Antibiotic Compound
PolyMedix, Inc., an emerging biotechnology company developing acute care products for infectious diseases and acute cardiovascular disorders, has received a notice of no objection from Health Canada for the Company"s Clinical Trial Application ("CTA") for its defensin mimetic antibiotic compound, PMX-30063. This notice of no objection allows for the initiation of the second human clinical study in Canada. PMX-30063 is a defensin mimetic antibiotic compound, the first of an entirely new class of antibiotic drugs that is believed to work in such a way that makes bacterial resistance unlikely to develop.
Oncology

Life-Saving Cardiac Rehabilitation

Coronary heart disease (CHD) is the leading cause of death worldwide and a major driver of medical and economic costs, especially among older adults. It has long been established that cardiac rehabilitation improves survival, at least in middle-aged, low- and moderate-risk white men. Now a large Brandeis University-led study published in the Journal of the American College of Cardiology reports that older cardiac patients benefit as much from cardiac rehab as their younger counterparts. Worldwide, in 2004, 7.2 million people died from CHD, while in the United States alone, more than 13 million people suffered from CHD, and almost half a million died from heart disease in 2003. Moreover, Americans aged 65 and older account for more than 55 percent of heart attacks and 86 percent of CHD deaths. "The good news is that patients who use cardiac rehab live longer than those who do not use it, regardless of their clinical diagnosis, gender, race, or socioeconomic background" said Dr. Jose Suaya, lead author and visiting scholar at the Heller School for Social Policy and Management at Brandeis University. The study showed that "patients with different clinical backgrounds - heart attacks, coronary bypass operations, and even congestive heart failure - all had lower mortality when using cardiac rehab," Dr. Suaya asserted. The study examined mortality in 601,099 Medicare beneficiaries who were hospitalized in 1997 for heart disease or bypass surgery and followed up through 2002. The study used three different statistical techniques to compare mortality between patients who used cardiac rehab and those who didn"t. Overall, within a span of five years, mortality rates were 21 percent to 34 percent lower in older adult patients who used cardiac rehab. Cardiac rehab is a covered benefit under Medicare. "Despite the significant benefits of cardiac rehab, only 12 percent of these patients actually took advantage of it," said Professor Donald Shepard, a health economist at the Heller School for Social Policy and Management at Brandeis. The regimen typically includes aerobic exercise and lifestyle counseling to reduce cholesterol, weight, and stress. The study found that patients who engaged in more than 24 sessions were an additional 19 percent less likely to die over five years than patients who used 24 sessions or fewer. The findings are magnified among the extreme elderly and patients with other diseases, such as diabetes, on top of their heart disease. These types of patients were even less likely than others to participate, but those who did attend obtained especially large gains from cardiac rehab. "This study should be a wake-up call to cardiac patients, their families, and their physicians that cardiac rehab can extend life and improve the quality of life, even in older people," said Dr. William Stason, senior scientist at the Heller School. "The evidence is clear. Cardiac rehab saves lives but it is severely underused," noted Dr. Philip Ades, Professor of Cardiology at the University of Vermont and a coauthor of the study. "The consistency of findings among the study"s methodologies increases the reliability of the findings," observed Prof. Sharon-Lise Normand of Harvard Medical School and Harvard School of Public Health, another co-author of the study. "More coronary patients should use cardiac rehab. Perhaps one way to achieve this would be to require hospitals and physicians to report rates of referrals and use of this service as quality indicators of their performance," Dr. Suaya and coauthors concluded. The study was funded by the Centers for Medicare & Medicaid Services. Laura Gardner Brandeis University


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