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New Safety Regulations Drive Greater Need For Res And Expertise At Every Stage Of Clinical Development
According to a report issued, drug safety leaders in pharmaceutical and biotechnology companies recognise the need to increase res, either internally or through partnerships, to comply with the safety regulations recently issued by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA). The report - Safety First: The Impact of New Regulations on Clinical Development - is based on a survey of 140 industry safety specialists, including heads of medical, drug safety, pharmacovigilance, and regulatory departments within large and mid-sized pharmaceutical companies and biotech firms. The survey found that more than three-quarters (77%) of respondents believe that new safety regulations have had a considerable impact on the industry as companies implement drug safety regulations throughout the clinical development process.

Cardium Presents Gene Activated Matrix Technology And Update On Excellarate Clinical Development Program At ASGT Annual Meeting
Cardium Therapeutics (NYSE Amex: CXM) and its subsidiary Tissue Repair Company (TRC) announced a presentation entitled "Phase 2b Study of GAM501 (Ad5PDGF-B/Collagen) in the Treatment of Diabetic Ulcers" at the Late Stage Industry Clinical Trials Symposium at the American Society of Gene Therapy (ASGT) Annual meeting in San Diego, California, on May 27, 2009. Dr. Barbara K. Sosnowski, Cardium"s Vice President of Biologics Development and the Chief Operating Officer of Cardium"s Tissue Repair Company Operating Unit, provided an update on TRC"s Phase 2b MATRIX clinical trial and the new formulation of the Excellarate(TM) product candidate, as well as an overview of the prior clinical study of Excellarate.
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APhA Publishes Reference On Drugs And Substances Of Abuse
The American Pharmacists Association (APhA) will publish in mid-July the second edition of Pagliaros" Comprehensive Guide to Drugs and Substances of Abuse. Written by veteran authors Louis A. Pagliaro and Ann Marie Pagliaro, the reference includes more than 100 monographs-11 of them new-dealing with each of the major drugs and substances of abuse used in North America, from acetone to zopiclone.
Cardiovascular

Washington D.C., Makes Improvements On HIV/AIDS Efforts, But More Work To Be Done, Report Finds; District Expands STD Testing Program For Students

The fifth annual report card from the Washington, D.C.,-based Appleseed Center for Law and Justice examining the district"s response to HIV gives the city "high marks for rapid testing, interagency coordination, surveillance and fighting the disease in the D.C. Jail," but finds that the city falls short in other areas, the Washington Examiner reports (Neibauer, 8/5). "The government also received above-average grades for leadership, managing grants to groups that help people with the illness, and monitoring the effectiveness of those programs," the Washington Post reports. However, "While Mayor Fenty and his administration deserve recognition for the continued support of ò€¦ numerous [HIV/AIDS Administration] initiatives, his public appearances and statements about the epidemic have fallen short of his enthusiasm for action inside the government," the report said. The report added that the district could do more to address HIV and recommended that HAA assess whether the improvements they have made are reducing the spread of the virus, according to the Post (Fears, 8/5). In related news, district officials are expanding a pilot program to all high schools in the coming year that offers tests for sexually transmitted diseases to students, the Post reports. The program began last year at eight local high schools and "found that 13 percent of about 3,000 students tested positive for an STD, mostly gonorrhea or chlamydia, according to the D.C. Department of Health," the article states. Walter Smith, executive director of the D.C. Appleseed Center for Law and Justice, said, "If 13 percent of these students are testing positive for STDs, those same kids could get HIV. A lot needs to be done to get the message out to the schools." The program was praised in D.C. Appleseed"s report released today on the district"s HIV/AIDS response (Fears/Hernandez, 8/5). This information was reprinted from dailyreports.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily U.S. HIV/AIDS Report, search the archives and sign up for email delivery at dailyreports.kff.org. © Henry J. Kaiser Family Foundation. All rights reserved.


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