Popular Articles

Harvard Researchers Say Insurers Put Profits Over Health
More than a decade after Harvard researchers first revealed that life and health insurance companies were major investors in tobacco stocks - prompting calls upon them to divest - the insurance industry has yet to kick the habit, they say.
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Bike Paths, Other 'Healthy' Infrastructure Projects Proving Controversial
"Attempts to set billions aside for infrastructure projects like bike paths face an uphill battle on Capitol Hill," The Chicago Tribune reports, adding "GOP legislators see no health savings in parks and similar projects," while advocates say preventive efforts will bring down costs. "A draft Senate bill would provide up to $10 billion annually for a "prevention and public health investment fund" -- a portion of which could be used for projects such as bike paths, sidewalks, farmers markets and other community interventions meant to curb chronic and costly conditions like obesity."
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Lobbyists Swarm Around Health Reform Activity
NPR began a series of reports on the health care lobbyists who attend Congressional sessions as part of their campaign. Richard Miller, a "longtime lobbyist for the American Chiropractic Association, says it"s important that the chiropractors keep on top of the health care overhaul legislation - and also take pains to make sure that senators and staff see them doing that, because the chiropractors are small dogs in a big fight." President Barack Obama "certainly sees Washington"s lobbyists as an obstacle to change. He"s tried limiting their access to the executive branch, but that runs into the constitutional question." Lobbying is on the rise: "Between 1998 and 2008, the number of registered lobbyists on health care more than doubled, to 3,627, according to the Center for Responsive Politics." Spending also increased: "Organizations lobbying on health care spent $484.4 million in 2008, more than two and a half times the spending in 1998." The project includes an interactive panoramic photo of lobbyists in the Senate HELP Committee hearing room and asks readers to help identify the players (Overby and Seabrook, 6/25).
Diagnostics

FDA Accepts For Review Spectrum's Response On ZEVALIN As A Class 1 Submission, And Establishes September 7, 2009 As Decision Date

Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial stage biotechnology company with a focus on oncology, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the resubmission to the Company"s supplement to the biologics license application for ZEVALIN (ibritumomab tiuxetan) in the first line consolidation setting on July 8, 2009. The FDA considers the review as a Class 1 submission to their complete response letter of July 2, 2009. Therefore, the user fee goal date is September 7, 2009. ZEVALIN is currently FDA approved and marketed by Spectrum Pharmaceuticals for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin"s Lymphoma, including patients who have rituximab-refractory follicular non-Hodgkin"s Lymphoma. About ZEVALIN® ZEVALIN® (ibritumomab tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the ZEVALIN therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell NHL, including patients with rituximab-refractory follicular NHL. ZEVALIN is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naç¯ve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL. Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan®) infusions. Yttrium-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the ZEVALIN therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to ZEVALIN therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). ZEVALIN should only be used by health care professionals qualified by training and experience in the safe use of radionuclides. For more information on ZEVALIN, patients and healthcare professionals can visit http://www.ZEVALIN.com. Spectrum Pharmaceuticals


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