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Mayo Clinic First in US to Test Stem Cells in Pediatric Congenital Heart Disease Patients

Posted: Published on June 11th, 2013

Released: 6/11/2013 2:00 PM EDT Source Newsroom: Mayo Clinic June 11, 2013 MULTIMEDIA ALERT: Animation of the surgical procedure as well as audio and video of Drs. Nelson and Burkhart are available for download from the Mayo Clinic News Network. http://www.mayoclinic.org/news2013-rst/7521.html Newswise ROCHESTER, Minn. -- Mayo Clinic has announced the first U.S. stem cell clinical trial for pediatric congenital heart disease. The trial aims to determine how stem cells from autologous umbilical cord blood can help children with hypoplastic left heart syndrome (HLHS), a rare defect in which the left side of the heart is critically underdeveloped. The trial will test the safety and feasibility of delivering a personalized cell-based therapy into the heart of 10 infants affected by HLHS. Today, treatment for babies born with HLHS involves three heart surgeries to redirect blood flow through the heart, or transplantation. The surgeries -- designed to provide adequate blood flow in and out of the heart, allowing the body to receive the oxygen-rich blood it needs -- are typically performed over the first few years of life. For this study, stem cells from newborns with HLHS will be collected from the umbilical cord following birth. The cord blood will be sent … Continue reading

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SanBio Announces FDA Clearance for the Initiation of a Phase I/2a Clinical Trial Testing Their Cell Therapy Product …

Posted: Published on June 11th, 2013

MOUNTAIN VIEW, Calif., June 10, 2013 /PRNewswire/ -- SanBio Inc., a California-based regenerative medicine company, announced today that the U.S. Food and Drug Administration has approved their Investigational New Drug application (IND) for the use of SB623, a novel allogeneic stem cell therapy product, in patients suffering from traumatic brain injuries (TBI's). This approval allows the company to proceed with a Phase 1/2a clinical trial testing the safety and feasibility of the therapy. The clinical trial is expected to be carried out at several major hospitals in the United States. "This is the second clinical program for SanBio," said Keita Mori, SanBio's Chief Executive Officer, "we see this as a clear validation of our development program and a significant broadening of the therapeutic application of our lead product SB623 for the treatment of unaddressed chronic neurological deficits." "We measure the responses of TBI patients to physical therapy every day. Progress is often painfully slow and incremental," said Dr. Daniel Lu, Principal Investigator, Neuroplasticity and Repair Laboratory and Director, Neuromotor Recovery Research Center, University of California, Los Angeles, "If this new cell therapy approach improves outcomes it could have a dramatic positive effect on many lives." About Traumatic Brain Injury: According … Continue reading

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Pastor Chui Depending on Source, Stem Cells Can Kill or Heal – Video

Posted: Published on June 11th, 2013

Pastor Chui Depending on Source, Stem Cells Can Kill or Heal This is a 13-minute sermon from science. It describes why adult stem cells heal and embryonic stem cells destroy life in them. Adult stem cells have more pro... By: Christopher Chui … Continue reading

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DGAP-News: Apricus Biosciences Receives European Approval for Vitaros(R) for the Treatment of Erectile Dysfunction

Posted: Published on June 11th, 2013

SAN DIEGO, 2013-06-10 13:00 CEST (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI) (http://www.apricusbio.com), today announced that its marketing application for Vitaros(r), indicated for the treatment of patients with erectile dysfunction ('ED'), has been approved through the European Decentralized Procedure ('DCP'). 'The approval of Vitaros(r) in Europe marks a significant milestone for Apricus Bio as we continue to execute on our core strategy of developing, seeking regulatory approval, and partnering our sexual health products,' said Richard Pascoe, Chief Executive Officer of Apricus Bio. 'Vitaros(r) has a unique product profile that meets the needs of a large number of patients suffering from erectile dysfunction and who are intolerant to or do not respond to current treatment options. With its rapid onset of action and unique topical delivery, we believe that Vitaros(r) will capture a significant share of the approximately $1 billion PDE-5 inhibitor market in Europe once it is launched by our commercial partners.' 'Moreover, partnering interest in Vitaros(r) remains strong and we are actively seeking to secure additional partnerships in the remaining European and global markets,' continued Pascoe. 'With the completion of a $17.1 million financing, the divestiture of multiple non-core assets, and streamlining of our … Continue reading

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Apricus Biosciences Receives European Approval for Vitaros(R) for the Treatment of Erectile Dysfunction

Posted: Published on June 11th, 2013

SAN DIEGO, June 10, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (APRI) (http://www.apricusbio.com), today announced that its marketing application for Vitaros(R), indicated for the treatment of patients with erectile dysfunction ("ED"), has been approved through the European Decentralized Procedure ("DCP"). "The approval of Vitaros(R) in Europe marks a significant milestone for Apricus Bio as we continue to execute on our core strategy of developing, seeking regulatory approval, and partnering our sexual health products," said Richard Pascoe, Chief Executive Officer of Apricus Bio. "Vitaros(R) has a unique product profile that meets the needs of a large number of patients suffering from erectile dysfunction and who are intolerant to or do not respond to current treatment options. With its rapid onset of action and unique topical delivery, we believe that Vitaros(R) will capture a significant share of the approximately $1 billion PDE-5 inhibitor market in Europe once it is launched by our commercial partners." "Moreover, partnering interest in Vitaros(R) remains strong and we are actively seeking to secure additional partnerships in the remaining European and global markets," continued Pascoe. "With the completion of a $17.1 million financing, the divestiture of multiple non-core assets, and streamlining of our … Continue reading

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Will a testosterone-boosting supplement work for you?

Posted: Published on June 11th, 2013

It is quite natural that men want to be more manly. In fact, hormone-related manliness is part of what makes us males take more risks, stress ourselves to work harder, and in general, do sometimes amazing, yet incredibly dangerous things like this. But for those of us who simply want to reverse the effects of aging, gain lean muscle and burn fat faster, the male hormone testosterone is also incredibly important. Many drug or supplement companies may take advantage of this need, and produce a testosterone "boosting" supplement that will make you into Rambo, Superman and the Incredible Hulk all rolled into one. Here is why it won't work, and some sound habits and actions that will. Why most testosterone boosting supplements fail. 1. They are distributed by big retail chains. Most of these places have HUGE overheads, especially in Singapore. Rental, staffing and storage costs are astronomical. This means a lot of your money goes into these overheads, rather than high product quality. So in general, if it can be bought at a store you find at a shopping mall, it's not the best value for you. 2. Linking on to point 1, is that many of the testosterone-boosting … Continue reading

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Marteka Fleming, Qyneesha Myers try to forge prescriptions, police say

Posted: Published on June 11th, 2013

LOPATCONG TWP., N.J. - Two N.J. women are facing charges after they allegedly tried to forge a Xanax prescription. Lopatcong Twp. police were called to the Phillipsburg Pharmacy at 96 Baltimore St. in Phillipsburg for a report of two women who tried to fill a fraudulent prescription around midnight Saturday. The women were identified as 36-year-old Marteka Fleming of S. 10th Street, and 30-year-old Qyneesha Myers of Washington St., both of Newark, N.J. Both were located later, sitting in a vehicle in front of the Rite Aid pharmacy at 755 Memorial Pkwy., where they were taken into custody. An investigation revealed that Fleming forged the prescription and gave it to Myers to fill at the Phillipsburg Pharmacy, where they were turned away, according to police. They drove to Rite Aid where township police located them. Both women were charged with forgery. Continued here: Marteka Fleming, Qyneesha Myers try to forge prescriptions, police say … Continue reading

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Biosimilars Legislation Introduced To Notify Patients of Changes to Prescriptions

Posted: Published on June 11th, 2013

WASHINGTON--(BUSINESS WIRE)-- The Biotechnology Industry Organization and the Delaware BioScience Association (Delaware Bio) commend the Delaware State Senate for introducing legislation designed to address the regulatory issues related to the interchangeability of biological medicines. The policies outlined in Senate Bill 118 align with BIOs principles on biologic substitution, therefore BIO support passage of this bill. While the U.S. Food and Drug Administration (FDA) oversees approval of biologic medicines, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must notify a consumer is covered by state law. Senate Bill 118 seeks to properly preserve the physician-patient relationship, protect patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies. Biosimilars are not generics. Even slight changes to a biologic drug can change its properties entirely. Unlike conventional generic medicines, biosimilars are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same, hence the name biosimilar. Those suggesting biosimilars and generics are the same are wrong. Patients and physicians managing chronic conditions are generally aware … Continue reading

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The trick, or treat, that is ‘Side Effects’

Posted: Published on June 11th, 2013

by Bert B. Sulat Jr. Posted on 06/11/2013 2:17 PM |Updated 06/11/2013 2:34 PM GOOD GIRLS GONE... Catherine Zeta-Jones (right) and Rooney Mara play shadowy figures in 'Side Effects.' All photos from the Side Effects Movie Facebook page MANILA, Philippines - The interesting Side Effects comes to theaters with some interesting, real-life trivia. For one thing, this will be the last big-screen movie from American director Steven Soderbergh in a long while, if not for good. This is due in part to his difficult experience in getting financing for his newer, biographical Liberace film Behind the Candelabra (which wound up being financed by HBO and is thus a cable TV release). Side Effects also features a fictitious drug for manic depressives or those with bipolar disorder the latter a condition that does afflict one of the films cast members, Catherine Zeta-Jones. And one of the movies lead characters gets mired in a sensational, paparazzi-luring controversy and the character is portrayed by sometime tabloid pet, Jude Law. Yet Soderbergh, who had helmed hits such as his Oceans trilogy, Out of Sight, Erin Brokovich and Magic Mike as well the lesser-known likes of The Limey, Solaris and The Girlfriend Experience, is not … Continue reading

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A path to lower-risk painkillers: Newly-discovered drug target paves way for alternatives to morphine

Posted: Published on June 11th, 2013

June 10, 2013 For patients managing cancer and other chronic health issues, painkillers such as morphine and Vicodin are often essential for pain relief. The body's natural tendency to develop tolerance to these medications, however, often requires patients to take higher doses -- increasing risks of harmful side effects and dependency. Now, new research from the University of Michigan Health System and a major pharmaceutical company has identified a novel approach to moderate and severe pain therapy that paves the way for lower dosage painkillers. The findings appear in Proceedings of the National Academy of Sciences. Drugs such as hydrocodone (the main ingredient of Vicodin) and oxycodone (Oxycontin) are often the best options for the treatment of moderate to severe pain for patients facing medical conditions ranging from a wisdom tooth extraction to cancer. The drugs bind to specific molecules (opioid receptors) on nerve cells in the brain and spinal cord to prevent the feeling of pain. "We have for the first time discovered compounds that bind to an alternative site on the nerve opioid receptors and that have significant potential to enhance the drug's positive impact without increasing negative side effects," says co-author John Traynor, Ph.D., professor of pharmacology … Continue reading

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