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ViroPharma Initiates Phase II Study – Analyst Blog

Posted: Published on June 6th, 2012

Referenced Stocks: VPHM, WPI ViroPharma Inc. ( VPHM ) recently announced the initiation of a phase II program. The phase II program will evaluate maribavir for the treatment of cytomegalovirus (CMV) infections in transplant recipients. Two independent phase II studies will be conducted under the program. The first independent clinical study will include subjects who have asymptomatic CMV. ViroPharma intends to enroll 160 subjects who have CMV viremia but do not have CMV organ disease. In this study, subjects cannot have CMV infection that is resistant to other anti-CMV agents. Patients in this study will be randomized to receive either oral maribavir (400mg, 800mg or 1200mg) or valganciclovir for up to 12 weeks. The study will monitor blood levels of CMV DNA. The second study will include treatment-failed patients. ViroPharma is planning to enroll 120 subjects who have demonstrated CMV viremia with or without CMV organ disease. In the study, subjects will be randomized to receive one of the three dosages of oral maribavir for up to 24 weeks. This study will monitor blood levels of CMV DNA. Maribavir has been granted orphan drug status in the US for the treatment of clinically significant CMV and disease in at-risk patients. … Continue reading

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ViroPharma Initiates Phase II Study

Posted: Published on June 6th, 2012

ViroPharma Inc. (VPHM) recently announced the initiation of a phase II program. The phase II program will evaluate maribavir for the treatment of cytomegalovirus (:CMV) infections in transplant recipients. Two independent phase II studies will be conducted under the program. The first independent clinical study will include subjects who have asymptomatic CMV. ViroPharma intends to enroll 160 subjects who have CMV viremia but do not have CMV organ disease. In this study, subjects cannot have CMV infection that is resistant to other anti-CMV agents. Patients in this study will be randomized to receive either oral maribavir (400mg, 800mg or 1200mg) or valganciclovir for up to 12 weeks. The study will monitor blood levels of CMV DNA. The second study will include treatment-failed patients. ViroPharma is planning to enroll 120 subjects who have demonstrated CMV viremia with or without CMV organ disease. In the study, subjects will be randomized to receive one of the three dosages of oral maribavir for up to 24 weeks. This study will monitor blood levels of CMV DNA. Maribavir has been granted orphan drug status in the US for the treatment of clinically significant CMV and disease in at-risk patients. Apart from maribavir, ViroPharma is working … Continue reading

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Genetic Risk Scores And Obesity Later In Life Among Children

Posted: Published on June 6th, 2012

Editor's Choice Academic Journal Main Category: Genetics Also Included In: Pediatrics / Children's Health;Obesity / Weight Loss / Fitness Article Date: 05 Jun 2012 - 14:00 PDT Current ratings for: 'Genetic Risk Scores And Obesity Later In Life Among Children' The researchers explain that obesity can be inherited and GWASs (genome-wide association studies) have started to reveal the molecular roots of heritability by identifying SNPs (single-nucleotide polymorphisms) which are associated with higher BMIs (body mass indexes). Daniel W. Belsky, Ph.D., and team wrote: The researchers gathered data on 1,037 New Zealanders who were members of the Dunedin Multidisciplinary Health and Development Study. 52% of them were males. They were all born between April 1972 and March 1973. They were assessed every few years up to the age of 38 years. Participants with higher GRSs (genetic risk scores) had greater BMIs between ages 3 to 38 for every age assessed. Children identified with a high genetic risk were found to have a 1.61 to 2.41 times higher chance of becoming obese during their teens to late thirties , and 1.90 times more likely to become chronically obese across over three assessments compared to the other kids. Children at higher genetic risk … Continue reading

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The 7 Greatest Viral Andy Samberg Videos

Posted: Published on June 6th, 2012

While we have the utmost faith in the young comedians future, we'd prefer, for the moment, to look back on the fantastic bits of comedy he's given us in the past. Which is why we've compiled his seven (in honor of the seven seasons he spent on the show) best SNL clips to have ever spread across the Internet faster than Paula Deen could polish off a stick of butter. 1. Dick in a Box If you celebrated Halloween in 2007, chances are you encountered some dude walking around with a box duct taped to his junk. Or maybe you were that guy. Whatever the case, we're sure the moment was enjoyable. And we're also sure the moment never would have occurred had Andy Samberg not teamed up with Justin Timberlake to deliver this Emmy-winning (really, that happened) short. 3. I'm on a Boat A year after "Jizz in My Pants" added new slang to your grandmother's vocabulary, Samberg created the greatest rap parody since Weird Al Yankovich's "Amish Paradise." With auto tune aficionado T-Pain on board for the ride, Samberg solidified his place as one of America's most consistently funny comedians. The hilarious, profanity laced clip garnered the guy … Continue reading

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Biodesix’ Paul Beresford Joins 2012 BIO Panel for Personalized Medicine Commercialization

Posted: Published on June 6th, 2012

BOULDER, Colo.--(BUSINESS WIRE)-- Biodesix, Inc., a fully integrated molecular diagnostics company dedicated to personalizing medicine, today announced that Paul Beresford, Ph.D., Vice President of Business Development and Strategic Marketing, will join industry veterans on a panel discussing the recipe for the successful commercialization of personalized medicine at the 2012 BIO International Conference being held in Boston, Mass. June 18-21, 2012. The panel, Commercialization of Personalized Medicine: Stakeholders' Recipe For Success, will take place on Tuesday, June 19th from 3:45-5:00 p.m. EDT. Beresford joins Mara Aspinall, president and CEO of Ventana Medical Systems, a Roche Group; Glenn Miller, Vice President and Head of Personalized Medicine at AstraZeneca; and Ron Andrews, President, Medical Sciences at Life Technologies on the panel. With help from the panelists, who are successfully pioneering diagnostic products for personalized medicine, this session will gauge the power of collaboration to fuel personalized medicine and novel diagnostics, detail early successes, identify major challenges and debate the most attractive models for commercialization. As personalized therapies continue to see rapid growth from the research side, this is the ideal time to create new business models that optimize the delivery of personalized medicine to patients by providing appropriate incentives to the businesses developing … Continue reading

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Merck Receives Complete Response Letter from U.S. Food and Drug Administration for Investigational Medicine …

Posted: Published on June 6th, 2012

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for ridaforolimus. Ridaforolimus is an investigational oral mTOR inhibitor under development for maintenance therapy for patients with metastatic soft tissue or bone sarcoma who have stable disease or better after four or more cycles of chemotherapy. The complete response letter states that FDA cannot approve the application in its present form, and that additional clinical trial(s) would need to be conducted to further assess safety and efficacy. Merck also is in ongoing discussions with health authorities in Europeandother countries as part of their application procedures for ridaforolimus for the treatment of metastatic soft-tissue or bone sarcomas in patients who had a favorable response to chemotherapy. Additionally, Merck is studying ridaforolimus in combination with other mechanisms in several tumor types. Merck remains confident in the potential of ridaforolimus, said Eric Rubin, M.D., vice president, Clinical Research Oncology, Merck. We will continue to work closely with the FDA to define potential paths forward for this investigational therapy. Sarcomas are a group of cancers of connective … Continue reading

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The potential impact of olfactory stem cells as therapy reported in Cell Transplantation

Posted: Published on June 6th, 2012

Public release date: 5-Jun-2012 [ | E-mail | Share ] Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair Tampa, Fla. (June 5 , 2012) A study characterizing the multipotency and transplantation value of olfactory stem cells, as well as the ease in obtaining them, has been published in a recent issue of Cell Transplantation (20:11/12), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/. "There is worldwide enthusiasm for cell transplantation therapy to repair failing organs," said study lead author Dr. Andrew Wetzig of the King Faisal Specialist Hospital and Research Centre in Riyadh, Saudi Arabia. "The olfactory mucosa of a patient's nose can provide cells that are potentially significant candidates for human tissue repair." According to the study authors, olfactory neural stem cells can be derived from a patient's own cells, they are readily available by a minimally invasive biopsy technique, and they can be expanded in vitro. The cells are plentiful because the olfactory epithelium undergoes neurogenesis and continual replacement of sensory neurons throughout adult life. "Using the rat as our animal model source, we examined the basic aspects of olfactory neural stem cell biology and its potential for self-renewal and phenotypic expression in various … Continue reading

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Costco pays $3.6 million for unsafe handling of drugs

Posted: Published on June 6th, 2012

Sacramento County District Attorney Jan Scully announced Monday that Costco Wholesale Corp. will pay $3.6 million in civil penalties and costs to settle a civil law enforcement action brought against the company by 30 California counties. The civil action was filed in Alameda Superior Court. The settlement resolves allegations that Costco violated California laws for the safe storage, handling and disposal of pharmaceutical and pharmacy waste, as well as other hazardous waste, according to a news release from Scully's office. The Alameda County District Attorney's Office and its counterparts in other counties conducted a joint investigation and prosecution to address statewide violations of law after San Joaquin County inspectors found evidence of improper storage, handling and disposal of hazardous waste and pharmaceutical waste products at Costco stores. Upon notification of the investigation, Costco officials cooperated with prosecutors and quickly brought their operations into compliance with hazardous waste management regulations, according to the news release. The violations occurred over a five-year period at numerous Costco stores and distribution centers statewide, including five stores in Sacramento County, Scully's office reported. "Improper handling and disposal of hazardous waste creates a health and safety risk to the citizens of Sacramento County and our environment," … Continue reading

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The potential impact of olfactory stem cells as therapy reported in Cell Transplantation

Posted: Published on June 6th, 2012

Public release date: 5-Jun-2012 [ | E-mail | Share ] Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair Tampa, Fla. (June 5 , 2012) A study characterizing the multipotency and transplantation value of olfactory stem cells, as well as the ease in obtaining them, has been published in a recent issue of Cell Transplantation (20:11/12), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/. "There is worldwide enthusiasm for cell transplantation therapy to repair failing organs," said study lead author Dr. Andrew Wetzig of the King Faisal Specialist Hospital and Research Centre in Riyadh, Saudi Arabia. "The olfactory mucosa of a patient's nose can provide cells that are potentially significant candidates for human tissue repair." According to the study authors, olfactory neural stem cells can be derived from a patient's own cells, they are readily available by a minimally invasive biopsy technique, and they can be expanded in vitro. The cells are plentiful because the olfactory epithelium undergoes neurogenesis and continual replacement of sensory neurons throughout adult life. "Using the rat as our animal model source, we examined the basic aspects of olfactory neural stem cell biology and its potential for self-renewal and phenotypic expression in various … Continue reading

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Cell transplantation of lung stem cells has beneficial impact for emphysema

Posted: Published on June 5th, 2012

Public release date: 4-Jun-2012 [ | E-mail | Share ] Contact: David Eve Celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair Tampa, Fla. (June 4, 2012) When autologous (self-donated) lung-derived mensenchymal stem cells (LMSCs) were transplanted endoscopically into 13 adult female sheep modeled with emphysema, post-transplant evaluation showed evidence of tissue regeneration with increased blood perfusion and extra cellular matrix content. Researchers concluded that their approach could represent a practical alternative to conventional stem cell-based therapy for treating emphysema. The study is published in Cell Transplantation (21:1), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/. "Mensenchymal stem cells are considered for transplantation because they are readily available, highly proliferative and display multi-lineage potential," said study corresponding author Dr. Edward P. Ingenito of the Brigham and Women's Hospital Division of Pulmonary and Critical Care Medicine. "Although MSCs have been isolated from various adult tissues - including fat, liver and lung tissues - cells derived from bone marrow (BM) have therapeutic utility and may be useful in treating advanced lung diseases, such as emphysema." However, according to the authors, previous transplantation studies, many of which used an intravenous delivery method, have shown that BM-MSCs have been only marginally successful in treating … Continue reading

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