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Bioheart Announces Acceptance Of Marvel-1 Data For Presentation At The Heart Failure Society Of America (HFSA) Meeting
Bioheart, Inc. (OTC Bulletin Board: BHRT) a company committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases announced today acceptance of MARVEL-1 data for presentation at the Heart Failure Society of America (HFSA) Meeting September 13-16th, 2009 in Boston, Massachusetts.
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Opinion Pieces Comment On Obama's Notre Dame Speech, Abortion Debate
Several newspapers recently published opinion pieces regarding President Obama"s commencement address at the University of Notre Dame. Summaries appear below.~ Cal Thomas, Washington Times: "Put aside the question of whether" Notre Dame should have invited President Obama to speak at its commencement ceremony on Sunday and "[f]ocus, instead, on [his] remarks and whether he is serious, or can be made so, about actually reducing the number of abortions in America," syndicated columnist Thomas writes in a Washington Times opinion piece. "Don"t put aside, however, the argument that there is only one reason to even want to reduce the number of abortions and that is that what is being killed, terminated, evacuated (choose your term) is, in fact, human life," Thomas adds. "In speaking of "original sin," the president hit upon why abortion has been so easily tolerated for so long," he writes, adding that Obama "spoke of "self-interest" and "crass materialism" but did so in the context of economics, not abortion." Thomas reports that Obama called for making adoption ""more available"" and providing ""care and support for women who do carry their children to term."" Thomas notes that Obama"s speech also included "an appeal for discussion and respect for people with different views," which was "a good beginning, but the ending is what counts, and the initial actions of this president when it comes to abortion and stem cell research have not been pro-life" (Thomas, Washington Times, 5/19).~ Tim Rutten, Los Angeles Times: After his commencement address at Notre Dame, "it"s now clear that the president is the rhetorical equivalent of a "money player,"" which is the "kind of competitor who steps up and delivers in the big games," Rutten writes in a Los Angeles Times opinion piece. Notre Dame"s invitation for Obama to speak at commencement and receive an honorary degree "bec[a]me an engine of controversy" because of protests from "reductionists," or conservative Catholics "who insist on bringing the broad sweep of Catholic social morality down to a single issue -- abortion," Rutten writes. However, Obama "negotiated the situation with remarkable ease," Rutten continues, adding that Obama was "speaking … to three audiences far from South Bend on Sunday." The first audience was the "crucial bloc of Catholic voters who seem to be looking for ways to remain in the Democratic Party," he writes. In addition, Obama was speaking to "those Catholic Democrats in public office ... who are under intense pressure from the reductionist bishops in their home dioceses" and to the U.S. Senate, which will likely ask Obama"s Supreme Court nominee about his or her views on abortion during confirmation hearings, Rutten continues. He concludes, "Even in Washington"s charged partisan atmosphere, it will be hard to ignore the president"s call for civility at Notre Dame" (Rutten, Los Angeles Times, 5/20).~ Clarence Page, Chicago Tribune: Obama "appropriately promoted" the "ability of adversaries to work together on mutual interests" in his commencement address, Page writes in a Tribune opinion piece. Page adds that the speech was "classic Obama the pragmatist: Look past ideology, try to ignore disagreements and work together on mutual interests." Obama said that "at some level, the views of the two camps are irreconcilable," Page writes, adding that it is "because Americans hold no values more dear than "life" and "choice."" Page adds that "[i]n the abortion debate, those values clash head-on." However, Obama"s "eloquent come-together oratory enabled him to leave the university like a hero, even though he glossed over the thorny specifics that drive wedges between people of goodwill when words are hammered into law," Page continues. "For now, by focusing on civility, the president apparently hopes to defuse the abortion powder keg long enough to address his higher priorities," Page writes, concluding, "The economy, national security and health care are going to be tough fight
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Siemens Mammomat Inspiration Wins Design Awards
Mammomat Inspiration, the digital mammography platform designed by Siemens and designaffairs, has received the iF Product Design Award 2009 and the red dot award: product design 2009. The device for the early detection of breast cancer shows that ease of use, high functionality, and unique design come together beautifully in a single medical engineering product.
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Genentech And Biogen Idec Submit Applications To The FDA For Rituxan For Most Common Type Of Adult Leukemia

Genentech, Inc. and Biogen Idec (Nasdaq:BIIB) announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan® (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL). The companies will request a priority review, and if granted, anticipate the FDA will make a decision within six months. CLL is the most common type of adult leukemia, accounting for one-third of all leukemias in the U.S. It is a slow-growing disease that occurs when too many abnormal white blood cells develop in the blood and bone marrow. The abnormal cells outnumber the normal white blood cells, making it difficult for the body to fight infection. The applications are based on positive results from two of the largest global Phase III clinical trials conducted in patients with CLL. The randomized, comparative studies, known as CLL8 and REACH, showed that Rituxan plus standard chemotherapy for CLL extended the time patients lived without the cancer advancing (progression-free survival or PFS) compared to those receiving chemotherapy alone. In CLL8, previously untreated patients who received Rituxan plus chemotherapy had a 69 percent improvement in PFS (41 percent risk reduction, hazard ratio=0.59; pAbout the CLL8 and REACH Studies Sponsored by Roche and conducted by the German CLL Study Group, CLL8 was a global, multi-center, randomized, open-label, Phase III study that enrolled 817 patients with previously untreated (first-line) CD20-positive CLL. REACH was a global, multi-center, randomized, open-label, Phase III study that enrolled 552 patients with relapsed CD20-positive CLL sponsored by Genentech, Biogen Idec and Roche. Both studies evaluated Rituxan plus fludarabine and cyclophosphamide chemotherapy compared with fludarabine and cyclosphosphamide alone. The primary endpoint for both studies was progression-free survival and secondary endpoints were overall survival, event-free survival, duration of response, response rate and complete response. In patients who had not received previous treatment (CLL8), the overall response rate was 93 percent in the Rituxan-treated arm compared to 85 percent in the chemotherapy alone arm. In patients whose cancer had relapsed after previous treatment (REACH), the overall response rate was 70 percent in the Rituxan-treated arm compared to 58 percent in the chemotherapy alone arm. No new safety signals were observed in either of the studies and safety was consistent with previous Rituxan experience. In CLL8, the most common adverse events that occurred more often in the Rituxan plus chemotherapy arm included blood and lymphatic system disorders, infections and neoplasms. Severe (Grade 3 or greater) events that occurred more often in the Rituxan plus chemotherapy arm included hematologic toxicity (56 percent vs. 39 percent), neutropenia (34 percent vs. 21 percent) and leukocytopenia (24 percent vs. 12 percent). In REACH, the most common adverse events that occurred more often in the Rituxan plus chemotherapy arm included blood and lymphatic system disorders, infections and neoplasms. Grade 3 or greater events such as neutropenia (42 percent vs. 40 percent), febrile neutropenia (15 percent vs. 12 percent) and neoplasms (7 percent vs. 3 percent) occurred more often in the Rituxan plus chemotherapy arm. Results from both studies were presented at the 50th Annual Meeting of the American Society of Hematology (ASH) in San Francisco in December 2008. About Chronic Lymphocytic Leukemia More than an estimated 90,000 Americans are living with the disease. It is largely a disease of older adults and the average age of diagnosis is 72. The American Cancer Society estimates that more than 15,000 new cases will be diagnosed and about 4,500 people will die from CLL this year. About Rituxan Rituxan is a therapeutic antibody that binds to a particular protein, the CD20 antigen found on the surface of malignant cells as well as normal B-cells. In non-Hodgkin"s lymphoma and rheumatoid arthritis (RA), Rituxan works with the body"s natural defenses to attack and kill the marked CD20 positive B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing B-cells to regenerate after treatment and return to normal levels in about 12 months for most patients. Rituxan first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin"s lymphoma as a single agent. It was also approved in the European Union under the trade name MabThera® in June 1998. Rituxan is also approved for the treatment of non-Hodgkin"s lymphoma for the following: - Previously untreated follicular, CD20-positive, B-cell non-Hodgkin"s lymphoma in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy. - Non-progressing (including stable disease), low-grade, CD20-positive, B-cell non-Hodgkin"s lymphoma as a single agent, after first-line CVP chemotherapy. - Previously untreated diffuse large B-cell, CD20-positive, non-Hodgkin"s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens. Rituxan received FDA approval for rheumatoid arthritis in February 2006 and is currently indicated in combination with methotrexate (MTX) to reduce signs and symptoms and to slow the progression of structural damage in adult patients with moderately-to severely-active rheumatoid arthritis who have had inadequate response to one or more TNF antagonist therapies. Genentech and Biogen Idec co-market Rituxan in the U.S., and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd. Rituxan Safety Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions and progressive multifocal leukoencephalopathy (PML). Hepatitis B reactivation with fulminant hepatitis, other viral infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation have also been observed. Patients should be closely observed for signs of infection if biologic agents and/or disease-modifying anti-rheumatic drugs (DMARDs) other than MTX are used concomitantly. The most common adverse reactions observed in Rituxan-treated RA patients are hypertension, nausea, upper respiratory tract infection, arthralgia, pruritus and pyrexia. The most common adverse reactions observed in Rituxan-treated NHL patients (incidence greater than or equal to 25 percent) are infusion reactions, fever, chills, infection, asthenia and lymphopenia. For additional safety information, please see the full prescribing information, including Boxed Warnings and Medication Guide, at 1-800-821-8590 or visit http://www.gene.com. Biogen Idec


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