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Critics: Obama shares outbreak blame

Posted: Published on October 11th, 2012

Under the Obama administration, the FDA has opted not to crack down on compounding pharmacies that are mass-producing cheaper drugs under less scrutiny than heavily regulated pharmaceuticals as part of a push to reduce health costs, a former top Bush-era FDA official told the Herald. The administration made the decision that having access to cheap drugs is more important than the assurances of safety and efficacy from the FDA, said Sheldon Bradshaw, the FDAs senior legal counsel in the George W. Bush administration who now works as a Washington lawyer representing corporations regulated by the FDA. The practices of one compounding pharmacy, Framingham-based New England Compounding Center, are now under federal and state investigation after the companys steroid injections for back pain were linked to the nationwide fungal meningitis outbreak that reportedly has sickened 119 and killed 11 people. Bradshaw said the administrations demand for cheap drugs was reflected in the FDAs decision in 2011 not to go after cheaper compounded versions of the premature birth prevention drug Makena, manufactured by KV Pharmaceuticals, which subsequently sued the FDA and lost. That act has emboldened pharmacy compounders and as a direct result, pharmacy compounders for the last year and a half … Continue reading →

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Pharmaceutical company helping in fight against prescription drug abuse

Posted: Published on October 11th, 2012

A pharmaceutical company has ventured into law enforcement. Purdue Pharma LP, the manufacturer of OxyContin and other prescription medications, has joined the fight against prescription drug abuse. Unique tablet markings, monitoring of drug counterfeiting and Internet distribution, analyses of pharmacy robbery and thefts in a database and tracking the supply chain are all part of the companys effort to combat abuse and diversion of prescription drugs. Experts from Purdue, based in Stamford, Conn., and the FBI Law Enforcement Executive Development Associations were in Bucks County Wednesday to train more than 25 officers from all over the state on preventing and responding to prescription drug abuse and diversion. The event, hosted by Warminster Police Chief Michael Murphy, was held at the Middle Atlantic-Great Lakes Organized Crime Law Enforcement Network office in Newtown Township. Our goal is to keep prescription drugs out of the hands of criminals and people who abuse and traffic them and we try to make sure that legitimate patients have access to them, said Landon Gibbs, director of law enforcement liaison and education at Purdue. Providing law enforcement with information helps them do their job successfully and spread awareness throughout the area about growing problem of abuse and … Continue reading →

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Nobel Prize for Physiology or Medicine Goes to Stem Cell Researchers

Posted: Published on October 11th, 2012

The Nobel Prize for Physiology or Medicine was announced on Monday. The award this year went to Sir John B. Gurdon and Dr. Shinya Yamanaka. The two men were awarded the Nobel Prize jointly, for their individual work in cloning and stem cell research. Monday's recognition marked the awarding of the first Nobel Prize for 2012. The rest of the Nobel Prize recipients will be announced throughout the next two weeks. Here is some of the key information regarding Gurdon and Yamanaka's work and Monday's Nobel Prize announcement. * Yamanaka and Gurdon did not work together or present shared research, even though they both concentrate their studies on a similar area of research. * Gurdon is actually being honored for work he did back in 1962. According to a New York Times report, he was the first person to clone an animal, a frog, opening the door to further research into stem cells and cloning. * Gurdon was able to produce live tadpoles from the adult cells of a frog, by removing the nucleus of a frog's egg and putting the adult cells in its place. * This "reprogramming" by Gurdon laid the groundwork for Yamanaka's work four decades later. … Continue reading →

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Immunovative, Inc. Announces Issuance of U.S. Patent on Key Scientific Breakthrough

Posted: Published on October 11th, 2012

NEW YORK, NY--(Marketwire - Oct 11, 2012) - Immunovative, Inc. ("IMUN" or the "Company") ( OTCBB : IMUN ) has today announced that Immunovative Therapies, Ltd. ("ITL") has been granted a U.S. Patent entitled "METHOD FOR ALLOGENEIC CELL THERAPY," which was issued September 25, 2012, under Patent No. 8,273,377. Foreign versions of this patent are pending around the world. This patent covers the proprietary method that utilizes immune cells from a normal donor to elicit an anti-tumor mechanism that mimics the Graft vs. Tumor (GVT) effect of non-myeloablative allogeneic stem cell transplants ("Mini-Transplant") without the toxicity of Graft vs. Host Disease (GVHD). Harnessing the power of the immune system to treat cancer and infectious disease has long been the goal of physicians and scientists. Unfortunately, cancer vaccines and cell immunotherapy methods have had difficulties in translating the promise of immune control into effect treatments. The most effective anti-cancer mechanism ever discovered is the GVT immune response that occurs after Mini-Transplant procedures. This mechanism can completely destroy chemotherapy-resistant metastatic cancers. Unfortunately, the clinical use of the GVT effect is severely limited due to extreme toxicity of an intimately related GVHD effect. Mini-Transplants are thus only widely used in advanced cases of … Continue reading →

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StemGenex™ on Adult Stem Cell-Based Therapy for Multiple Sclerosis

Posted: Published on October 11th, 2012

LA JOLLA, Calif., Oct. 10, 2012 /PRNewswire/ --New research directions are being explored to find therapies for hard to treat diseases. One exciting new approach is the use of autologous Adult Stem Cells. Multiple Sclerosis (MS) is one of the many notable diseasesadult stem cell therapycould potentially impact. Multiple Sclerosis (MS) is a disorder in which an individual's own immune system attacks the 'myelin sheath'. The myelin sheath serves to protect the nerve cells within the body's central nervous system (CNS). The damage caused by MS may result in many types of symptoms including: (Photo: http://photos.prnewswire.com/prnh/20121010/LA89802-INFO) Currently there is no cure for MS, but MS stem cell therapiesattempt to slow the disease's progression and limit symptoms. Since adult stem cells have the ability to differentiate into many different types of cells, such as those required for proper functioning and protection of nerve cells, the use of adult stem cells for MS therapy could be of substantial value. Adult stem cells can be isolated with relative ease from an individual's own 'adipose' (fat) tissue. As a result, adult stem cell therapy is not subject to the ethical or religious issues troubling embryonic methods. Encouragingly for MS treatment potential, scientific researchers have … Continue reading →

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First Patient Treated in Cytori’s U.S. Cell Therapy Heart Failure Trial

Posted: Published on October 11th, 2012

SAN DIEGO & MINNEAPOLIS--(BUSINESS WIRE)-- Cytori Therapeutics (CYTX) announced the initiation of the FDA approved ATHENA clinical trial to investigate Cytoris cell therapy in patients who suffer from a severe form of refractory (untreatable) heart failure due to chronic myocardial ischemia. Cytoris cell therapy is based on a patients own adipose-derived stem and regenerative cells (ADRCs) processed by the Companys proprietary Celution System technology, making this the first FDA approved trial in the U.S. to evaluate ADRCs for cardiovascular disease. This first patient was treated by co-principal investigator Timothy Henry, M.D., Director of Research, at the Minneapolis Heart Institute Foundation in September and has undergone a seven day follow-up assessment. More details on the ATHENA trial may be found at http://www.theathenatrial.com. Patients with refractory heart failure have no options except for heart transplant, for which there are few hearts available, said Dr. Henry. Cell therapy such as Cytoris has the potential to delay, halt, or even reverse this progression. We believe this is accomplished by the cells ability to promote angiogenesis and regulate the immune response to help revive damaged tissue that is alive yet not necessarily contributing to its fullest capacity toward the pumping ability of the heart. ATHENA … Continue reading →

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Work just beginning as drugmakers put Nobel discoveries to test

Posted: Published on October 11th, 2012

* Hundreds of receptors are targets for drug discovery * Goal is to make better drugs with fewer side effects * Potential to treat a vast array of diseases By Julie Steenhuysen and Ben Hirschler CHICAGO/LONDON, Oct (KOSDAQ: 039200.KQ - news) 10 (Reuters) - For some scientists, winning a Nobel Prize marks the end of a long and successful career. But the work, in a sense, is just beginning for newly minted Nobel laureates in chemistry Dr. Brian Kobilka, 57, of Stanford University in California, and his mentor, Dr. Robert Lefkowitz, 69, of Duke University Medical Center in Durham, North Carolina. "There is still a lot to do," Kobilka said in a telephone interview from his home in Palo Alto, California, where he learned of his prize early on Wednesday morning. "There is a lot to do." In research spanning four decades, the scientists working separately and together have helped to characterize the exact structure of an important class of proteins known as G-protein-coupled receptors or GPCRs, which serve as a main conduit for chemicals to get past a cell's membrane and be taken up by a cell. Roughly 1,000 human genes carry genetic codes for the receptors, which affect … Continue reading →

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Health Canada warns against use of highest dose of anti-nausea IV drug Zofran

Posted: Published on October 11th, 2012

Health officials in Canada are warning about potentially life-threatening side effects associated with an anti-nausea drug. Zofran, a drug thats administered at 32 milligrams intravenously, should be avoided altogether, Health Canada is warning. The agency is warning that the drug administered at this dose can impact a patients QT interval, a measure of a hearts electrical activity. Zofran at this dose can prolong a patients QT interval. This condition can lead to dizziness and cause an irregular heartbeat. A report from Canada Broadcasting Corp. adds that QT interval can also cause fainting and death. QT prolongation could also result in a fatal condition known as Torsades de Pointes. Considering these dangerous side effects, Health Canada has mandated that no higher dose than 16 milligrams of Zofran be administered to patients. This drug, at 32 milligrams, is dispensed to patients who undergo chemotherapy in the treatment of cancer and to post-operative patients to prevent nausea and vomiting. In addition to its brand name form, Zofran is also known asondansetron hydrochloride dihydrate or ondansetron in generic form. Health Canadas warning does not include any dosing instruction changes for lower doses of Zofran, including those who are given the drug orally and for … Continue reading →

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Americans Win Nobel for Figuring Out How the Human Body Talks to Cells

Posted: Published on October 11th, 2012

Dr. Robert J. Lefkowitz and Dr. Brian K. Kobilka are the reason drug makers can and will make drugs with fewer side effects, and after 40 years spent studying the body's protein receptors, they have won the 2012 Nobel Prize in Chemistry. Lefkowitz and Kobilka have been researching "G-protein-coupled receptors," which are the protein receptors and form of communication the body uses to tell cells what's going on. An example The New York Times's Kenneth Chang uses is what we know as "fight-or-flight." Lefkowitz and Kobilka figured out how G-protein-receptors figure into all of that."They serve as the gateway to the cells," Lefkowitz said in report by CNN's Ben Brumfieldthe receptors sense adrenaline, which sets off reactions and triggers within the cell. "Around half of all medications act through these receptors, among them beta blockers, antihistamines, and various kinds of psychiatric medications," explained the academy in Brumfield's report. Experts believe the research will only lead to better medicine. "In particular Kobilka's work in determining the structure of G-protein coupled receptors has revolutionised our understanding of how they work as small 'molecular machines' and will lead to enormous advances in drug design,"one expert told the BBC. Read more from the original … Continue reading →

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Salvation Army celebrates 80 years of helping men overcome addition

Posted: Published on October 11th, 2012

St. Louis (KSDK) - On Wednesday the Salvation Army celebrated 80 years of helping men recover from drug addictions. More than 900,000 men have gone through the Adult Rehabilitation Center's chemical dependency rehabilitation program. On Wednesday some current clients in the program graduated to the next level and listened to a big success story. Five years ago Raven Steele was a drug user and dealer, was shot twice, and even went to jail. Now he works as the program's communications specialist. "The Salvation Army no short of saved my life I was given an opportunity to rehabilitate myself and restore myself through going to work every morning, participating in chapel services and counseling services and the consequence of that was a spiritual awakening where you learn that the way you have been living is a slow suicide and it takes an effort on your part to kind of turn the tide," said Steele. In honor of 80 years the mayor's office declared Wednesday "Salvation Army Arc Day." KSDK Read the rest here: Salvation Army celebrates 80 years of helping men overcome addition … Continue reading →

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