Categories
Cardiovascular
Diagnostics
Endocrinology
Health Insurance
Medical Devices
Mental Health
Nutrition
Oncology
Public Health
Sexual Health
Popular Articles

Whistleblower Case Against Healthways, Inc. Settled For $40,000,000
A 15-year whistleblower case filed by a former employee against Healthways, Inc. has been settled for approximately $40,000,000 in damages and fees. The case was initiated in June 1994, when A. Scott Pogue, who had recently been fired from his job as a marketing representative for a company called Diabetes Treatment Centers of America, filed a case in Nashville under the United States Civil False Claims Act against his former employer.

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.
News of the day
CHMP Recommends 'Januvia(R)'(sitagliptin), From MSD, For Restricted First Line Use In European Union
Merck & Co., Inc. (Whitehouse Station, N.J., U.S.A.), which operates in many countries as Merck Sharp & Dohme (MSD), has received a positive opinion from the European Medicines Agency"s (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommending restricted first line use of "Januvia" (sitagliptin) for the treatment of type 2 diabetes. With this positive opinion, the CHMP recommends that sitagliptin be indicated to improve glycaemic control when diet and exercise alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. If this opinion is accepted by the European Commission, sitagliptin will be the only diabetes treatment in the DPP-4 inhibitor class to have a restricted first line indication.
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


Add your comment:
Name:
Site address: http://
Your message:
Enter today\\\\'s date, 2 digits
(spam protection):

© Copyright 2009