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ViroPharma Receives FDA Approval of Cinryze® (C1 Esterase Inhibitor [Human]) Industrial Scale Manufacturing

Posted: Published on August 6th, 2012

EXTON, Pa., Aug. 6, 2012 /PRNewswire/ --ViroPharma Incorporated (VPHM) today announced the U.S. Food and Drug Administration (FDA) has approved the supplement to the Cinryze Biologics License Application (BLA) for industrial scale manufacturing changes. As previously announced, the company expects completion of labeling for previously produced vials to take approximately six weeks before entering into the trade. The company also announced that it expects to release its financial results for the second quarter of 2012 on Thursday, August 9, 2012 before the open of the U.S. financial markets. The company will host a conference call and live audio webcast at 9:00 a.m. Eastern Time on the same day. During the conference call, ViroPharma management will discuss the 2012 second quarter financial results and other business. The press release and the live webcast of the conference call will be accessible via ViroPharma's corporate website at http://www.viropharma.com. An audio archive will be available at the same address until August 20, 2012. To participate in the conference call, please dial (800) 874-4559 (domestic) and (302) 607-2019 (international). After placing the call, please tell the operator you wish to join the ViroPharma investor conference call. "We believe the approval of our supplement for industrial … Continue reading

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New Study Defines the Genetic Map of the Jewish Diasporas

Posted: Published on August 6th, 2012

Newswise August 6, 2012 (Bronx, NY) A new genetic analysis focusing on Jews from North Africa has provided an overall genetic map of the Jewish Diasporas. The findings support the historical record of Middle Eastern Jews settling in North Africa during Classical Antiquity, proselytizing and marrying local populations, and, in the process, forming distinct populations that stayed largely intact for more than 2,000 years. The study, led by researchers at Albert Einstein College of Medicine of Yeshiva University, was published online today in the Proceedings of the National Academy of Sciences. Our new findings define North African Jews, complete the overall population structure for the various groups of the Jewish Diaspora, and enhance the case for a biological basis for Jewishness, said study leader Harry Ostrer, M.D., professor of pathology, of genetics and of pediatrics at Einstein and director of genetic and genomic testing for the division of clinical pathology at Montefiore Medical Center. Dr. Ostrer noted that obtaining a comprehensive genetic fingerprint of various Jewish subpopulations can help reveal genetic links to heart disease, cancer, diabetes and other common diseases. In a previous genetic analysis, the researchers showed that modern-day Sephardic (Greek and Turkish), Ashkenazi (Eastern European) and Mizrahi … Continue reading

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Cytomedix Announces Medicare Coverage for Autologous PRP Gel in Chronic Wound Care

Posted: Published on August 6th, 2012

GAITHERSBURG, MD--(Marketwire -08/06/12)- Cytomedix, Inc. (CMXI) (CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Centers for Medicare & Medicaid Services ("CMS") has issued a final National Coverage Determination ("NCD") for autologous blood-derived products for chronic non-healing wounds. As previously reported, on May 9, 2012 CMS posted its proposed NCD, which was followed by a 30-day public comment period that ended on June 8th. In the final decision memo released August 2nd, CMS responded to these comments, refined its decision and confirmed coverage for autologous platelet rich plasma ("PRP") in patients with diabetic, pressure and/or venous wounds via its Coverage with Evidence Development ("CED") program. CED is a process through which CMS provides reimbursement coverage for items and services while generating additional clinical data to demonstrate their impact on health outcomes. In the final decision memo, CMS noted that it " ...has reviewed the medical literature on autologous PRP in patients with chronic wounds and believes that CED is appropriate for PRP treatment," and concluded that, "when reviewed as a body of evidence, it does indicate that PRP shows promise in the populations … Continue reading

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Pluristem stem cell therapy saves woman with bone marrow failure

Posted: Published on August 6th, 2012

The share price of Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) is soaring on the TASE, after the company announced that its placental stem cell therapy, Placental eXpanded (PLX), saved the life of a 54-year old Israeli woman suffering from terminal bone marrow failure. This was the second successful treatment of a patient with bone marrow failure in three months, under compassionate use protocols. The PLX therapy was administered at Hadassah Medical Center in Jerusalem. The patient, who was diagnosed with lymphoma cancer, failed to respond to chemotherapy and bone marrow transplants. Intermuscular injection of PLX cells improved the woman's clinical condition and blood count, and she was released from the isolation unit and subsequently discharged from the hospital. "This is a real breakthrough - the woman was in isolation due to low white blood cells and high susceptibility to infections and in addition her red blood cells and platelets were low, leading to a very dangerous and life-threatening situation," said Professor Reuven Or, Director of Bone Marrow Transplantation and Cancer Immunology at Hadassah. "Further, autologous bone marrow transplantation that she received engrafted poorly, and as a last resort, we applied for a compassionate treatment using Pluristem's PLX cells based … Continue reading

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San Rafael dog gets arthritis relief from stem cell treatment

Posted: Published on August 6th, 2012

Emma, a snow-white German shepherd, has been plagued with arthritis for two years, limping and sometimes crying out in pain. But an innovative new procedure using her own stem cells has helped, her veterinarian and owner say. "Her joint mobility has improved. I can move her elbows into a flexed position now," said Kristina Hansson, a veterinarian with San Rafael's Northbay Animal Hospital. Hansson injected Emma's own stem cells into 10 of her joints three months ago in a yet-unproven procedure that cost about $2,000, promoted by MediVet America, a Kentucky company. "We're very pleased," said Arthur Latno of San Rafael, owner of the 9-year-old, 80-pound dog. "She doesn't limp any more and she doesn't cry." Latno He is apparently one of the first Marin pet owners to do so. Though there are some practitioners in Marin who use stem cell therapy, it is not yet widespread, according to Andrew Lie, a veterinarian at the East San Rafael Veterinary Clinic and president of the Marin County Veterinary Medical Association. Lie himself doesn't use the therapy. "Personally, I think I would wait to see more research and studies come out. I think it's a little early "This (the stem cell procedure) … Continue reading

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Pluristem stem cells save second patient with bone marrow failure

Posted: Published on August 6th, 2012

Pluristem Therapeutics said another patient suffering from bone marrow failure was saved using its placenta-based stem cell treatment. This is the second time in three months that a patient suffering from bone marrow failure was successfully treated with its PLX cells, the Israeli company said on Monday. The patient, a 54 year-old woman with lymphoma cancer, was treated with chemotherapy but her condition continued to deteriorate, necessitating a bone marrow transplant. The transplant, as well as alternate therapies, were not successful. Pluristem's PLX cells were then administered to the patient at Jerusalem's Hadassah Medical Center under the Israeli government's compassionate use program. Following the injection of the PLX cells intramuscularly, the woman's clinical condition and blood counts improved to the point where the patient was released from the isolation unit and subsequently discharged from the hospital. "This is a real breakthrough - the woman was in isolation due to low white blood cells and high susceptibility to infections and in addition her red blood cells and platelets were low, leading to a very dangerous and life-threatening situation," Reuven Or, director of bone marrow transplantation and cancer immunology at Hadassah, said in a statement. "The treatment with PLX has saved her … Continue reading

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Equity Briefing: Pluristem’s PLX Cell Therapy in Failed Bone Marrow Transplant Proven Successful a Second Time

Posted: Published on August 6th, 2012

Last month we examined emerging biotech Pluristem Therapeutics (PSTI), whose cell therapy treats vascular disease with a novel intramuscular injection that restores patency to damaged arteries. Now, this pioneering technique is showing promise in healing another medical disorder with few alternatives - failed bone marrow transplant (BMT). BMT, a physically demanding ordeal unchanged in procedure since 1968, is performed on 30,000 patients per year at a cost of billions of dollars. Full recover takes up to one year. In the last few months, Pluristem has been making significant progress with a substitute for BMT. In May, a seven-year old girl with aplastic anemia was treated with two intramuscular injections of PLX cells after repeated failed BMTs, and showed rapid recovery in all three blood cell components as Pluristem`s therapy stimulated hematopoietic stem cells. In June, the company`s data at the 2012 Bio International Convention showed positive results of an intramuscular injection of its PLX cells on a range of blood disorders that included primary and secondary bone marrow failure from chemotherapy and radiation therapy in cancer, and acute radiation syndrome (ARS). Now, a second patient with lymphoma has been treated with PLX cells for a failing BMT, in the same … Continue reading

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Equity Briefing: Pluristem's PLX Cell Therapy in Failed Bone Marrow Transplant Proven Successful a Second Time

Posted: Published on August 6th, 2012

Last month we examined emerging biotech Pluristem Therapeutics (PSTI), whose cell therapy treats vascular disease with a novel intramuscular injection that restores patency to damaged arteries. Now, this pioneering technique is showing promise in healing another medical disorder with few alternatives - failed bone marrow transplant (BMT). BMT, a physically demanding ordeal unchanged in procedure since 1968, is performed on 30,000 patients per year at a cost of billions of dollars. Full recover takes up to one year. In the last few months, Pluristem has been making significant progress with a substitute for BMT. In May, a seven-year old girl with aplastic anemia was treated with two intramuscular injections of PLX cells after repeated failed BMTs, and showed rapid recovery in all three blood cell components as Pluristem`s therapy stimulated hematopoietic stem cells. In June, the company`s data at the 2012 Bio International Convention showed positive results of an intramuscular injection of its PLX cells on a range of blood disorders that included primary and secondary bone marrow failure from chemotherapy and radiation therapy in cancer, and acute radiation syndrome (ARS). Now, a second patient with lymphoma has been treated with PLX cells for a failing BMT, in the same … Continue reading

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YPSILANTI: Dawn Farm Jamboree to be held Sept. 9

Posted: Published on August 6th, 2012

The annual Dawn Farm Jamboree celebrates recovery from chemical dependency with a free event that includes entertainment for the entire family, from 1 to 6 p.m. Sept. 9 at Dawn Farm, 6633 Stony Creek Road, Ypsilanti. The celebration features live music by NoteWorthy, hayrides, a live and silent auction, children's tent and midway, food and beverages and a chance to interact with farm animals. September is designated National Alcohol and Drug Addiction Recovery Month for individuals, families and communities around the country to celebrate recovery. Admission to the jamboree and all activities are free. The jamboree also provides an opportunity to support the community services provided by Dawn Farm, the only nonprofit program of its kind in Washtenaw County and one of the few in the state that provides care for young people with drug and alcohol problems. All donations made during the celebration will support the organization's mission of providing professional care for people with alcohol and other drug addictions who lack resources and need help. The celebration features live music by NoteWorthy, hayrides, a live and silent auction, children's tent and midway, food and beverages and a chance to interact with farm animals. September is designated National Alcohol … Continue reading

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King County facility to direct people with mental illness and drug dependency into treatment

Posted: Published on August 6th, 2012

A unique coalition of government officials, law enforcement agencies, and social service providers announce the opening of an innovative new facility designed to divert people with a mental illness or drug dependency crisis from our local jails and hospital emergency rooms and into King Countys Crisis Solutions Center (CSC). The Crisis Solutions Center is a unique 16 bed facility located in the Jackson Place neighborhood of Seattle. The Center, combined with a longer term respite facility and mobile crisis team, is one of 37 strategies funded by the King County Mental Illness and Drug Dependency Sales Tax, a fund created by the King County Council to support new or expanded mental health and chemical dependency programs throughout King County . The CSC is designed to provide immediate mental health and chemical dependency services to individuals who are in crisis. Individuals can be diverted to the CSC by either police officers in the field, hospital ER staff or first responders in order to avoid involvement in more costly systems such as jails and hospitals. The CSC includes a crisis diversion program where an individual can stay for up to three days (16 beds), and an adjoining program where individuals who need … Continue reading

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