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Dr. David B. Samadi Introduces New Prostate Cancer Care Center For Robotic Surgery Patients At Mount Sinai Medical Center
The Mount Sinai Medical Center has a new re center for prostate cancer treatment. Led by David B. Samadi, M.D., Chief of the Division of Robotics and Minimally Invasive Surgery in the Department of Urology, the new state-of-the-art facility at 625 Madison Avenue in New York City specializes in pre- and post-surgery care for patients who undergo a robotic prostatectomy at Mount Sinai"s main campus. It also provides expertise in the treatment of other urologic cancers, including bladder and kidney. A multilingual staff offers assistance with patient travel arrangements, accommodations, and translation services when required.
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Sixteen States, DOJ Join Whistle-Blower Lawsuits Alleging Wyeth Defrauded Medicaid Programs
The U.S. Department of Justice and 16 states have joined two whistle-blower lawsuits filed in federal District Court in Massachusetts alleging that Wyeth defrauded the government by not offering the same discounts on two medications to Medicaid that it offered to hospitals, the Wall Street Journal reports. The lawsuits were initiated following a grand-jury investigation by the U.S. Attorney"s Office in Massachusetts (Johnson, Wall Street Journal, 5/19). The other states included in the lawsuits are California, Delaware, Florida, Illinois, Indiana, Louisiana, New York, Michigan, Nevada, New Hampshire, Tennessee, Texas, Virginia, Wisconsin and the District of Columbia (Barrett, AP/Austin American-Statesman, 5/18).According to the lawsuits, Wyeth from 2000 to 2006 sold hospitals a bundled package called the Protonix Performance Agreement, which included its acid-reflux drugs Protonix Oral and Protonix IV. The suits allege that Wyeth gave hospitals up to a 94% discount for the oral version under the deal, with the understanding that when patients were released from hospitals they would be switched from the intravenous version of the drug to the oral version. According to the complaint, Wyeth hoped to gain an edge in a competitive market for acid-reflux pills by taking advantage of its standing as the only company offering an IV acid-reflux drug. The Journal reports that Wyeth charged hospitals $20 per vial for the IV version of Protonix and $3 for the oral version.Medicaid rules stipulate that the program is entitled to the lowest price on prescription drugs, and drugmakers are required to pay states rebates if they offer discounts to any other entities. The lawsuits state that Wyeth avoided paying hundreds of millions of dollars to state Medicaid programs because it did not offer the programs the same discounts or provide rebates (Wall Street Journal, 5/19).The lawsuits are seeking financial penalties against Wyeth of up to three times the amount lost by Medicaid. Assistant Attorney General Tony West said, "By offering massive discounts to hospitals, but then hiding that information from the Medicaid program, we believe Wyeth caused Medicaid programs throughout the country to pay much more for these drugs than they should have." Wyeth spokesperson Doug Petkus said that Wyeth "believes that its pricing calculations were correct and intends to defend itself vigorously in these actions" (AP/Austin American-Statesman, 5/18).
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Pneumonia Caused By Community-Acquired MRSA: An Emerging And Deadly Threat, Usually Preceded By Flu
As community-acquired infections due to meticillin-resistant Staphylococcus aureus (CA-MRSA) increase, so lethal cases of CA-MRSA pneumonia are also on the rise. A paper in the June edition of looks at the emerging and deadly threat of community-acquired necrotising pneumonia due to CA-MRSA. CA-MRSA pneumonia appears to occur most commonly following an influenza-like illness and may have special relevance given the emergence of H1N1 influenza.
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Journal Of Clinical Oncology Publishes Study Demonstrating Improvement In Overall Response And Progression-Free Survival-Chronic Lymphocytic Leukemia

Cephalon, Inc. (Nasdaq: CEPH) announced yesterday that the Journal of Clinical Oncology has published data from a pivotal phase 3 study demonstrating that TREANDA® (bendamustine HCl) for Injection improved clinical outcomes when compared to chlorambucil in patients with chronic lymphocytic leukemia (CLL). Results of this study were the basis of the March 2008 U.S. Food and Drug Administration (FDA) approval of TREANDA for CLL, the first agent approved by the FDA for this disease since 2001. According to the American Cancer Society, there will be more than 15,000 new cases of CLL diagnosed in 2009 alone. The study results were published online today and will also appear in the print edition later this year. This Phase 3, randomized, international, multicenter, open-label study evaluated the efficacy and safety of TREANDA compared to chlorambucil in previously untreated patients with advanced (Binet stage B-C) CLL. Patients received TREANDA (100 mg per square meter on days 1 and 2) (n=162) or chlorambucil (0.8 mg/kg on days 1 and 15) (n=157) for up to six treatment cycles. In this study, TREANDA demonstrated significantly better outcomes for both primary endpoints compared to chlorambucil: overall response rate and progression-free survival (PFS).The overall response rate was significantly higher in patients receiving TREANDA than chlorambucil (68% vs. 31%; pAbout TREANDA TREANDA, a novel chemotherapy, was approved by the FDA for the treatment of CLL in March 2008. Efficacy relative to other first line therapies other than chlorambucil has not been established. TREANDA received its second approval in October 2008 for the treatment of patients with indolent B-cell non-Hodgkin"s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The following serious adverse reactions have been associated with TREANDA in clinical trials: myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, skin reactions, and other malignancies. TREANDA has a unique chemical structure that is synthesized to combine an alkylating group and a purine-like benzimidazole component. Though the exact mechanism of action of TREANDA remains unknown, TREANDA may act in two distinct ways to kill cancer cells. Preclinical studies suggest that TREANDA may lead to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death pathway which disrupts normal cell division known as mitotic catastrophe (a non-apoptotic pathway). Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Deutschland GmbH. Bendamustine HCl, the active ingredient in TREANDA, is marketed in Germany by Astellas" licensee, Mundipharma International Corporation Limited. In Germany, bendamustine is indicated as a single-agent or in combination with other anti-cancer agents for indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to develop and market bendamustine HCl in Japan and select Asia Pacific Rim countries. Cephalon, Inc.


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