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Shire Selects SAS(R) Drug Development To Handle Clinical Trials Data
SAS, the leader in business analytics, announced that Shire, the global specialty biopharmaceutical company, has selected SAS® Drug Development as the platform for its clinical trials data.

UK Charity Tackles Health Risk For Children - Engaging Website Launches To Educate Children At A Crucial Age In Bone Development
Research from the National Osteoporosis Society has revealed that almost half (49%)* of young people do not know that there are steps they can take to keep their bones healthy. This knowledge gap puts them at risk of osteoporosis and fractures in later life.
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New Democrat Coalition Proposes Independent Panel To Oversee Comparative Effectiveness Research
Members of the moderate New Democrat Coalition on Tuesday proposed legislation (HR 2502) that would establish a non-governmental, independent office to oversee research efforts to compare the effectiveness of medical treatments, CQ HealthBeat reports. The bill would create the Health Care Comparative Effectiveness Research Institute, which would use money remaining from the $1.1 billion included in the economic stimulus package for comparative effectiveness research and additional funding from fees on Medicare and private insurers. HCCERI would be overseen by a 21-member board -- appointed by the U.S. Comptroller General -- that would include HHS officials, patients, physicians, private insurers and others (Norman, CQ HealthBeat, 5/19). In contrast, a panel to oversee comparative effectiveness research established by a provision in the stimulus bill would be made up of government health experts (Mundy, "Washington Wire," Wall Street Journal, 5/19). According to CQ HealthBeat, some people have raised concerns that comparative effectiveness research funded by the stimulus bill would result in research that could be used to deny coverage for certain treatments and that cost would factor disproportionately in such decisions. Rep. Kurt Schrader (D-Ore.), who introduced the bill, said HCCERI"s goal would be to ensure that medical decisions remain between physicians and patients and that both doctors and patients have the most understandable information possible to make such decisions. HCCERI also would make public its methods for deciding which research projects to approve, as well as any links the institute has to industry, its research protocols and the names of researchers. HCCERI would accept public comment before creating new research guidelines, and all research would be subject to peer review. In addition, HCCERI in commissioning studies would take steps to account for differences in patients" gender, race, age and ethnicity (CQ HealthBeat, 5/19).Schrader said that the bill "will bring patients, along with health care providers, physicians and industry, to the decision-making process," adding, "By having a seat at the table, the American people will help drive the direction of research based on what is most important to them" ("Washington Wire," Wall Street Journal, 5/19). Rep. Allyson Schwartz (D-Pa.) said that New Democrats seek to lower costs and improve quality of care, so "the most important thing we can do is to incentivize innovation and to provide that information on the best practices and best interventions and get that information out to providers." Industry Reaction
Diagnostics

A.P. Pharma Announces FDA Acceptance Of APF530 New Drug Application For Chemotherapy-Induced Nausea And Vomiting

A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for APF530 for the potential treatment of chemotherapy-induced nausea and vomiting (CINV). APF530 is a long-acting formulation of granisetron that utilizes the Company"s proprietary Biochronomer™ drug delivery system. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has issued an action date of March 18, 2010. "The acceptance of the APF530 NDA represents another important step towards providing physicians and patients with a potential new long-acting therapeutic agent to combat chemotherapy-induced nausea and vomiting," said Ronald J. Prentki, A.P. Pharma"s President and Chief Executive Officer. "Our team recognizes the important role APF530 could play in cancer care, and we are dedicated to working with the FDA as it reviews our NDA submission." The NDA was submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the Company can rely upon the FDA"s prior safety and efficacy findings for APF530"s active ingredient, granisetron. About APF530 A.P. Pharma"s lead product candidate, APF530, is being developed for the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting (CINV). APF530 contains the 5-HT3 antagonist, granisetron, formulated in our proprietary Biochronomer™ drug delivery system, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. Injections and oral tablets containing granisetron are approved for the prevention of acute onset CINV, but not for delayed onset CINV. Granisetron was selected because it is widely prescribed by physicians based on a well-established record of safety and efficacy. In September 2008, A.P. Pharma reported positive top-line results from its pivotal Phase 3 study. In this multi-center, randomized trial that enrolled 1,395 cancer patients, APF530 was shown to be equally as effective as (statistically non-inferior to) palonosetron (Aloxi®) in the prevention of both acute onset and delayed onset CINV. The NDA for APF530 was submitted in May 2009 and the FDA set a Prescription Drug User Fee Act (PDUFA) date of March 18, 2010. Palonosetron is the only injectable 5-HT3 antagonist FDA-approved for the prevention of delayed onset CINV. APF530 was also generally well-tolerated in this study. About CINV Prevention and control of nausea and vomiting, or emesis, are very important in the treatment of cancer patients. The majority of patients receiving chemotherapy will experience some degree of emesis if not prevented with an anti-emetic, typically administered just prior to chemotherapy. Chemotherapy treatments can be classified as moderately emetogenic, meaning that 30% to 90% of patients experience CINV, or highly emetogenic, meaning that more than 90% of patients experience CINV, if they do not receive an anti-emetic. Acute onset CINV occurs within the first 24 hours following chemotherapy treatment. Delayed onset CINV occurs more than 24 hours after treatment and may persist for several days. Prevention of CINV is important because the distress caused by CINV can severely disrupt patient quality of life and can lead some patients to delay or discontinue chemotherapy. A.P. Pharma


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