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Docs Say 'Wait' on Weight Loss Drugs

Posted: Published on July 21st, 2012

After a 13-year dry spell, the U.S. Food and Drug Administration has approved two new drugs promising weight loss in a pill. But will you be able to get a prescription for them? The answer may depend on which doctor you see. "I'll probably take a wait-and-see attitude myself," said Greg Anderson, an assistant professor of family medicine at the Mayo Clinic. "The track record has not been particularly good for diet medications." By contrast, Dr. Albert Levy, assistant professor of medicine at the Mount Sinai School of Medicine, said he has already been prescribing the same combination of drugs in the newest offering off-label for two years, a decision based on data from previous clinical trials. He said almost all of his patients lost weight when they were given the medications. "Once the patient has learned how to control the appetite and has lost a good amount of weight, she or he is stimulated to continue to lose weight without the medications," Levy said. The two medications in question are Belviq and Qsymia. Belviq, which contains a new medication called lorcaserin, was approved June 27. Qsymia, approved earlier this week, is a combination of two medications which had already … Continue reading

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NABP Stresses Need for International Collaboration to Combat Online Counterfeit Drug Distribution

Posted: Published on July 21st, 2012

MOUNT PROSPECT, Ill., July 20, 2012 /PRNewswire-USNewswire/ -- The National Association of Boards of Pharmacy(NABP) today issued a report about the continually increasing online counterfeit drug supply and the urgent need for international collaboration among regulators and other public agencies as well as private sector entities. As described in the Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: July 2012, counterfeit drugs sold online often make their way to unwary consumers through a complex chain of international transactions by multiple parties, and international, public-private collaborative efforts are needed to combat this illegal activity. NABP continues to review and monitor Web sites selling prescription drugs and its findings are also presented in the report released today of more than 10,000 Web sites analyzed, 97% operate out of compliance with pharmacy laws and practice standards established in the United States, and many other developed countries, to protect public health. Such sites provide an outlet for counterfeit medicines to enter the US drug supply, endangering the health and safety of Americans. The report provides an overview of collaborative strategies from pharmacy experts to stop online counterfeit drug distribution. Public and private sector experts on international health law and global … Continue reading

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Wellpartner Expands Executive Staff

Posted: Published on July 21st, 2012

PORTLAND, Ore.--(BUSINESS WIRE)-- Wellpartner, a nationally recognized provider of pharmacy distribution and contract pharmacy services, today announced the addition of Anthony Zappa, PharmD, and Michael Majerik to its senior staff. As the new Vice President of Contract Pharmacy Services Operations, Dr. Zappa will oversee all aspects of contract pharmacy program implementation and service delivery to Wellpartners growing roster of safety net hospital clients. Mr. Majerik joins Wellpartner as Vice President of Sales & Marketing and will lead the companys sales growth and expansion into new markets. Prior to joining Wellpartner, Dr. Zappa served in an operational executive capacity at Fairview Pharmacy Services, BioScrip, Diversified Pharmaceutical Services and SmthKlineBeecham. In addition, he was a founder of Interpharm, the first PBM in South Africa. Dr. Zappas clinical experience includes several years of hospital and retail pharmacy practice. Michael Majerik provides Wellpartner with more than twenty years of healthcare sales, marketing, business development and operations experience. Over his career, Mr. Majerik served in executive positions at Alere, Magellan Health Services, and CorSolutions among others. Most recently, he founded a strategic healthcare consulting group working with start-up organizations on strategic vision execution and go-to-market strategies. Given the prospects for future growth, the time is … Continue reading

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Seattle Genetics Announces ADCETRIS® Receives Positive CHMP Opinion for Conditional Approval in European Union

Posted: Published on July 20th, 2012

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) today announced that its collaborator, Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the conditional marketing authorization of ADCETRIS (brentuximab vedotin) for two indications: (1) the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. The positive opinion from CHMP and broad label recommendation is a key step in the European regulatory process for ADCETRIS and brings us closer to our goal of making this important new therapy globally available to patients with relapsed Hodgkin lymphoma or systemic ALCL, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. If approved in the European Union, ADCETRIS will represent the first new therapeutic advance for relapsed Hodgkin lymphoma patients in … Continue reading

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Takeda and Millennium Announce Positive CHMP Opinion for Conditional Approval of ADCETRIS® (brentuximab vedotin) in …

Posted: Published on July 20th, 2012

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESSWIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502, Takeda) and Millennium: The Takeda Oncology Company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for conditional approval of brentuximab vedotin for two indications: (1) the treatment of adult patients with relapsed or refractory CD30 positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and sALCL. The CHMP opinion is based on data from clinical trials and other supportive data in relapsed or refractory HL and relapsed or refractory sALCL. We are very pleased with the CHMP positive recommendation for brentuximab vedotin, said Trevor Smith, Head of Commercial Operations, Europe & Canada, Takeda Pharmaceuticals. Takeda is dedicated to developing innovative and novel therapeutics that make a real difference to patients lives. If approved, brentuximab vedotin will be the third product in the Takeda … Continue reading

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Millennium and Takeda Announce Positive CHMP Opinion for Conditional Approval of ADCETRIS® (brentuximab vedotin) in …

Posted: Published on July 20th, 2012

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESSWIRE)-- Millennium: The Takeda Oncology Company and, Takeda Pharmaceutical Company Limited (TSE:4502, Takeda) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for conditional approval of brentuximab vedotin for two indications: (1) the treatment of adult patients with relapsed or refractory CD30 positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and sALCL. The CHMP opinion is based on data from clinical trials and other supportive data in relapsed or refractory HL and relapsed or refractory sALCL. We are very pleased with the CHMP positive recommendation for brentuximab vedotin, said Trevor Smith, Head of Commercial Operations, Europe & Canada, Takeda Pharmaceuticals. Takeda is dedicated to developing innovative and novel therapeutics that make a real difference to patients lives. If approved, brentuximab vedotin will be the third product in the Takeda … Continue reading

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The yin and yang of stem cell quiescence and proliferation

Posted: Published on July 20th, 2012

ScienceDaily (July 19, 2012) Not all adult stem cells are created equal. Some are busy regenerating worn out or damaged tissues, while their quieter brethren serve as a strategic back-up crew that only steps in when demand shoots up. Now, researchers at the Stowers Institute for Medical Research have identified an important molecular cue that keeps quiescent mouse hematopoietic (or blood-forming) stem cells from proliferating when their services are not needed. Publishing in the July 20, 2012 issue of Cell, the team led by Stowers Investigator Linheng Li, Ph.D., report that Flamingo and Frizzled 8, a tag team best known for its role in establishing cell polarity, are crucial for maintaining a quiescent reserve pool of hematopoietic stem cells in mouse bone marrow. Their finding adds new insight into the mechanism that controls the delicate balance between long-term maintenance of stem cells and the requirements of ongoing tissue maintenance and regeneration. "Hematopoietic stem cells daily produce billions of blood cells via a strict hierarchy of lineage-specific progenitors," says Li. "Identifying the molecular signals that allow hematopoietic stem cell populations to sustain this level of output over a lifetime is fundamental to understanding the development of different cell types, the nature … Continue reading

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Research and Markets: OECD Report: Disease and Therapy Review – Epilepsy

Posted: Published on July 20th, 2012

DUBLIN--(BUSINESS WIRE)-- Research and Markets (http://www.researchandmarkets.com/research/mjblwp/disease_and_therap) has announced the addition of the "Disease and Therapy Review: Epilepsy" report to their offering. The Epilepsy Disease and Therapy Review provides an overview of the disease and related conditions, with incidence and prevalence numbers and percentages for major countries worldwide, information on diagnosis, and an overview of treatment. Dosing and treatment cost information is provided for various treatment types. General information on the epilepsy market, as well as sales of leading drugs and therapies are provided. Disease and Therapy Reviews were developed to provide a basic understanding of the key facts about a disease and market in a quick, easy-to-read format. These reports are prepared by the senior market research team of Timely Data Resources. Each Disease and TherapyReview provides a conciseanalysis of the most important informationabout a particular disease, its treatment, and the market opportunities. Reports begin with an overview of the condition, and also contain tables that summarize the available worldwide incidence and prevalence data for the condition, a review of current diagnosis strategiesand treatment options, general information about the market size, and information about important market trends. Thedata contained in these reportscomes fromkey industry secondary data sources,such asthe Timely Data … Continue reading

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Franklin Hospital is working to prevent strokes

Posted: Published on July 20th, 2012

Franklin Hospital is participating in the American Heart Association/American Stroke Associations Get With The Guidelines Stroke program. Emergency room director Shirley Spangler said the programs goal is to improve the overall quality of care for stroke patients by improving acute stroke treatment and preventing future strokes and cardiovascular events. Lee H. Schwamm, M.D. and chair of the Get With The Guidelines National Steering Committee and director of the TeleStroke and Acute Stroke Services at Massachusetts General Hospital in Boston commends the hospital for its commitment to implementing standards of care and protocols for treating stroke patients. Get With The Guidelines Stroke was developed to help hospitals employ proven science-based treatment guidelines, including those developed by the American Stroke Association, American Heart Association and Brain Attack Coalition, he said. These guidelines address acute stroke management, primary prevention of cardiovascular diseases, secondary prevention of strokes and the establishment of primary stroke centers. Spangler said as a program participant, Franklin Hospital is encouraged to develop a comprehensive system for providing rapid diagnosis and treatment of stroke when patients are admitted to the emergency department. This includes being equipped to provide brain-imaging scans, making neurologists available to conduct patient evaluations and using clot-busting medications … Continue reading

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Better management of traumatic brain injury

Posted: Published on July 20th, 2012

ScienceDaily (July 19, 2012) New treatments to lessen the severity of the more than 21,000 Traumatic Brain Injury (TBI) cases that occur in Australia each year are on the horizon. Published July 19 in the journal, Brain, a study led by researchers from Monash University's Australian Centre for Blood Diseases (ACBD) revealed how inhibiting certain enzymes decreased the severity of TBI, providing a target for future treatments. Caused by a blow to the head, often suffered during falls or road crashes, severe TBI can result in long-term disability or death. Effects can include impairments to cognitive and motor function, vision, hearing and emotional regulation. Additionally, the post-injury disruption to blood flow, oxygen supply and nerve function around the brain has been linked to debilitating diseases including Alzheimer's disease and post-traumatic epilepsy. The study was led by Professor Robert Medcalf and Dr Maithili Sashindranath of the ACBD, who collaborated for five years with scientists at the University of Geneva in Switzerland and the University of Michigan in the United States. Professor Medcalf said the researchers identified two enzymes, known as t-PA and MMP-3, that act together to promote injury severity following TBI. "The enzyme t-PA, well known for its ability to … Continue reading

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