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Northern California Cancer Center's First-of-Its-Kind Research Reveals Low Socioeconomic Status Often Equals Poor Chance Of Lymphoma Survival
The Northern California Cancer Center (NCCC) recently found that lower socioeconomic status is "significantly associated with substantially poorer survival" of follicular lymphoma in California.
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Sleep Difficulties May Occur With Parental Presence At Bedtime
Parental presence at bedtimes appears to have a greater negative impact on infant sleep than actual co-sleeping, according to a research abstract that will be presented on Wednesday, June 10, at SLEEP 2009, the 23rd Annual Meeting of the Associated Professional Sleep Societies.
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House, Senate Committees Release Draft Health Care Reform Proposals
Democratic leaders in the House and Senate on Tuesday released draft versions of health care reform legislation in their respective chambers that outline several initiatives, including a public health insurance option that has been the focus of debate between Democratic leaders who favor it and Republicans and moderate Democrats who oppose the provision, The Hill reports (Soraghan, The Hill, 6/9). According to the New York Times, the draft bills represent an emerging consensus between the Senate and House on how to move forward with health reform (Pear, New York Times, 6/10).The Senate Health, Education, Labor and Pensions Committee"s 615-page draft health care bill would expand eligibility for Medicaid and allow families with incomes up to 500% of the federal poverty level to qualify for subsidies to purchase insurance. In addition, the bill includes an individual mandate requiring U.S. residents to purchase insurance, reforms for the insurance market, suspension of coverage denials based on pre-existing conditions and the establishment of a health insurance exchange where U.S. residents can compare and buy coverage (Budoff Brown, Politico, 6/9). Sen. Christopher Dodd (D-Conn.), the second-ranking Democrat on the HELP Committee, will lead mark-up sessions scheduled to begin June 16 while Committee Chair Edward Kennedy (D-Mass.) undergoes treatment for brain cancer (The Hill, 6/9). At a meeting of the House Democratic Caucus, the leaders of the three House committees charged with crafting health reform legislation outlined a bill with similar provisions to the one being written in the Senate (New York Times, 6/10). The bill -- which is being drafted by the chairs of the House Ways and Means, Energy and Commerce, and Education and Labor committees -- calls for a public plan, an individual mandate, a mandate for employers to help pay for coverage and the creation of a health insurance exchange. Under the House bill, families with incomes up to 400% of the federal poverty level would qualify for subsidies for insurance. The House bill also would expand Medicaid by determining eligibility entirely on income, according to a House aide. Currently, many Medicaid applicants must meet other criteria, such as being a parent, in addition to having a low income, to qualify. The House is expected to release a formal version of the bill next week.Both draft bills released on Tuesday did not include details on how the proposals would be financed. According to the Wall Street Journal the omission gives lawmakers time to better assess the costs involved and promote health reform to the public (Bendavid/Adamy, Wall Street Journal, 6/10).
Endocrinology

Shire Receives Fast Track Designation For Velaglucerase Alfa For Gaucher Disease

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type I Gaucher disease. Shire is working with the FDA to determine subsequent steps and timing for the filing of its NDA. Fast Track designation is an FDA approved process that facilitates the development and expedites the review of drugs to treat serious diseases and fill an unmet medical need with the goal of getting important new treatments to patients earlier. This process allows a company to file the sections of the NDA as they become available instead of filing all the sections at once. It also enables the agency to commence its review and proceed on a rolling basis as the additional sections are completed and submitted for review. Shire is completing a phase III clinical program that includes three phase III controlled studies involving over 100 patients at 24 sites in 10 countries around the world. On July 6th, Shire announced that it filed a treatment protocol for velaglucerase alfa at the request of the FDA, which if accepted would allow physicians to treat Gaucher disease patients with velaglucerase alfa on an early access basis, ahead of commercial availability in the US. Under the conditions of the treatment protocol, Shire would provide velaglucerase alfa free of charge initially, in order to provide access to patients as quickly as possible. Velaglucerase alfa is made with Shire"s proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and carries a human glycosylation pattern. Background on Gaucher disease Gaucher disease is an autosomal recessive disease and the most prevalent Lysosomal Storage Disorder (LSD), with an incidence of about 1 in 20,000 live births. Despite the fact that Gaucher Disease consists of a phenotype, with varying degrees of severity, it has been sub-divided in three subtypes according to the presence or absence of neurological involvement. It is also the most common genetic disease affecting Ashkenazi Jewish people (Eastern, Central and Northern European ancestry), with a carrier frequency of 1 in 10 (Dr. John Barranger and Dr. Ed Ginns 1989). This panethnic disease involves many organ systems, such as liver, spleen, lungs, brain, metabolism and bone marrow. Gaucher Disease results from a specific enzyme deficiency in the body, caused by a genetic mutation received from both parents. The disease course is quite variable, ranging from no outward symptoms to severe disability and death. Carrier status can be detected through blood or saliva to identify potential carriers of the Gaucher gene. Gaucher Disease can be diagnosed early through a blood test. Worldwide the diagnosed population of Gaucher Disease patients is approximately 7,000. Based on incidence, the estimated total world population is likely to be between 10,000 and 15,000 patients. SHIRE PLC Shire"s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire"s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results. "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company"s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company"s Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company"s products; the Company"s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company"s products; the Company"s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company"s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company"s filings with the Securities and Exchange Commission. Shire Plc


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