Celiac Disease Clinical Trials - Global Review, H1, 2015

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Riassunto Takeda presenta una richiesta di nuovo farmaco per ixazomib, per il trattamento dei pazienti con mieloma multiplo recidivato/refrattario

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Myeloproliferative Disorders Pipeline Insights

. Wellbutrin XL (Bupropion) with no prescription DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/md9zj4/myeloproliferative) has announced the addition of the "Myeloproliferative Disorders-Pipeline Insights" report to their offering. Myeloproliferative Disorders Pipeline Insights provides the in-depth analysis of the pipeline assets across the Myeloproliferative Disorders. Buy Snacks online Gyne-Lotrimin (Clotrimazole) without Rx The main objective of this report to track competitor pipeline molecules, related research activities, technology, collaborations, in-licensing and out-licensing deals. http://cardiobloodreview.wordpress.com Oxsoralen (Methoxsalen) with free Rx The Myeloproliferative Disorders Report helps to identify emerging players with potentially strong product information and create effective counter-strategies to gain competitive advantage. Myeloproliferative Disorders Pipeline Insights Report covers the Myeloproliferative Disorders pipeline molecules at various stages of development like Pre-registration phase, clinical phases (Phase III, Phase II & Phase I), pre-clinical and discovery phases. Buy Levitra Oral Jelly (Vardenafil) without Rx The Report also provides Myeloproliferative Disorders related therapeutic assessments by molecule type, route of administration, monotherapy and combination products. Desal with free Rx The Report also highlights the discontinued and inactive projects in pipeline for Myeloproliferative Disorders. Scope - The report provides a Myeloproliferative Disorders Landscape across the globe - The report provides drug profiles which includes product description, MOA, licensors & collaborators, technology, development partner and chemical information - Coverage of the Myeloproliferative Disorders pipeline on the basis of target, MOA, route of administration, technology involved and molecule type - The report reviews key players involved in the therapeutics development for Myeloproliferative Disorders and also provide company profiling - Pipeline products coverage based on various stages of development from NDA filings to discovery. - Provides pipeline assessment by monotherapy and combination therapy products, stage of development and molecule type For more information visit .researchandmarkets.com/research/md9zj4/myeloproliferative

Vesey Street Capital Partners Affiliate Acquires Leading Provider of Continuing Medical Education

NEW YORK--(BUSINESS WIRE)--An affiliate of Vesey Street Capital Partners L.L.C. Demadex (Torsemide) (VSCP), a private equity firm dedicated to middle market health care services investments, today announced the acquisition of Imedex, LLC (“Imedex”), a provider of accredited, independent Continuing Medical Education (CME) to industry professionals via in-person conferences and online education forums. About Rulide (Roxithromycin) with free Rx Located in Alpharetta, Georgia, Imedex was previously a subsidiary of AmerisourceBergen, a global pharmaceutical sourcing and distribution service company. “Imedex plays a critical role educating physicians in key specialty areas within the healthcare spectrum, including oncology, hematology, and gastroenterology. Parafon Forte (Chlorzoxazone) with free Rx The Company’s leading industry presence and world class content will provide significant growth over the long-term. Cytotec with no Rx We view this as an excellent platform acquisition and hope to deploy additional capital through industry consolidation opportunities,” said Adam Feinstein, Founder and General Partner of Vesey Street Capital Partners. Andrew “Andy” Schutt, the former General Manager and Vice President of Imedex, was named as the Company’s Chief Executive Officer. Buy Ampicillin (Acillin) with no Rx Mr. Buy Psoriasis online Schutt, said, “We welcome VSCP as a partner and look forward to expanding our market presence through strategic investments. http://allegra-opinion.blogspot.com VSCP’s vast experience operating in the physician, payor and hospital markets will provide valuable insight as we move forward as an independent provider.” Steve Geringer has been named Chairman of Imedex Holdco, LLC. Mr. Geringer is Chairman of AmSurg Corporation (NASDAQ: AMSG), a nationwide provider of ambulatory surgery centers and outsourced physician services; a Director of Addus HomeCare Corp. (NASDAQ: ADUS), a provider of home and community-based services; and a Director of a variety of other companies in the health care industry, successfully building shareholder value throughout his career. “Imedex is a strategic platform with a significant opportunity to grow its accredited physician-oriented CME programs which serve the global pharmaceutical market. We are confident that under Andy’s leadership, the Imedex team will further enhance its leadership position and realize its growth potential,” said Mr. Geringer. ABOUT VESEY STREET CAPITAL PARTNERS L.L.C. Vesey Street Capital Partners (VSCP) is a private equity firm founded in 2014 with a dedicated focus on middle market health care services. VSCP’s focused strategy is centered upon investing primarily in founder owned businesses and corporate carve-outs that create value for hospitals, physicians, payors and post-acute care providers by enhancing operating efficiencies, improving quality of care, reducing costs and increasing revenue. VSCP has significant experience in healthcare services and creates value for portfolio companies by leveraging its vast network of industry relationships and its distinguished investor group consisting of healthcare leaders, health care companies and family offices. The acquisition of Imedex, LLC through its affiliate Imedex Holdco, LLC represents the firm’s second investment following last year’s recapitalization of ScribeAmerica, the nation’s leading provider of medical scribe services, .scribeamerica.com. For more information on Vesey Street Capital Partners, visit .vscpllc.com. ABOUT IMEDEX, LLC Imedex is an established leader in the independent accredited health care education industry. The Company’s programs focus on improving patient care around the world through live events and online courses. CME credits are required for practicing physicians and the conferences provide a forum for physicians to interact and exchange ideas and best practices. Since its inception in 2001, Imedex has organized 50,000 e-learning experiences annually and more than 97,000 live meeting attendees in 29 countries. The Company has a global footprint and operates in the United States, Europe and Asia. The Company recently hosted the ESMO 17th World Congress on Gastrointestinal Cancer in Barcelona, Spain, which was attended by ~3,300 physicians.

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Type 2 diabetes linked with reduced cognitive function

Researchers have revealed that over just 2 years, the ability of people with type 2 diabetes to regulate their blood flow is reduced, impairing the cognitive and executive skills. The study focused on older adults, assessing participants with an average age of 66. When blood flow is regulated normally, the brain can redistribute blood to areas that become more active during specific tasks. "People with type 2 diabetes have impaired blood flow regulation," explains study author Dr. About Combivir (Lamivudine - Zidovudine) with free Rx Vera Novak, from Harvard Medical School in Boston, MA. Buy Starlix (Nateglinide) without prescription "Our results suggest that diabetes and high blood sugar impose a chronic negative effect on cognitive and decision-making skills." Type 2 diabetes has previously been established as an independent risk for the development of both cognitive impairment and dementia. About Shuddha guggulu () with free prescription In their study, published in Neurology, the researchers wanted to investigate how inflammation, blood flow regulation in the brain and cognitive decline were related in people with the metabolic disorder. The researchers examined a small cohort of 40 people - 19 with type 2 diabetes and 21 without diabetes. About Cyclessa with free prescription The average age of the participants was 66. Asendin (Amoxapine) with no Rx The participants that had type 2 diabetes had all been treated for the disease for more than 5 years, receiving an average of 13 years of treatment. For the study, the researchers conducted an array of tests on the participants. Buy PMS Relief online They assessed their cognitive and memory functions while also taking magnetic resonance imaging (MRI) scans and blood tests to measure brain volume, blood flow and inflammation. http://doctor-answers.blogspot.com/ After 2 years, the researchers repeated the tests. They found that the participants with type 2 diabetes experienced a reduction in their capacity to regulate the blood flow in their brains. These participants also performed worse in the cognitive and memory function tests. Participants whose blood flow regulation was poorest at the start of the study experienced the greatest declines in their ability to perform basic routine tasks such as bathing and cooking, defined as decline in executive function. Additionally, the researchers found that the participants who experienced the highest levels of inflammation also had the greatest decreases in blood flow regulation, regardless of whether their diabetes and blood pressure were well controlled or not. Blood flow regulation monitoring could help predict cognitive changes Over the 2 years of the study, there was a marked difference in the learning and memory skills of the participants with type 2 diabetes compared with those without the disease. Average test scores fell by 12%, from 46 to 41, among those with type 2 diabetes while the scores of those without diabetes remained steady at 55 points. Among the participants with type 2 diabetes, the researchers found that blood flow regulation decreased by around 65% overall. "Early detection and monitoring of blood flow regulation may be an important predictor of accelerated changes in cognitive and decision-making skills," Dr. Novak suggests. Only conducting the tests on the participants twice, at the start of the study and 2 years later, means that the study does not reveal much about how cognitive and executive function in people with type 2 diabetes alters over time. The authors partially acknowledge this limitation, stating another study involving a larger sample size and longer duration is required to shed further light on the time sequence of the relationship between blood flow regulation and the disease. Other limitations of the study are that the researchers did not measure for other factors that could have contributed to cognitive impairment among the participants and that younger participants were not involved in the study. Despite these, the authors believe that their research provides clinical evidence regarding the mechanisms of the long-term effects of type 2 diabetes on the brain, with implications for health care and future treatment for older people with the disease. Recently, Medical News Today reported on a study suggesting that high levels of blood sugar could be a cause of Alzheimer s disease. Written by James McIntosh

Scientists isolate unwanted marijuana side effects

Scientists have successfully isolated the medical benefits of cannabis from its unwanted side effects. Augmentin (Amoxicillin And Clavulanate) without prescription Scientists have successfully isolated the unwanted side effects of cannabis from its medical benefits. Researchers from both the University of East Anglia (UEA), in the UK and University of Pompeu Fabra in Barcelona, Spain, carried out their research on mice and discovered how the main psychoactive ingredient in cannabis, tetrahydrocannabinol, or delta-9-tetrahydrocannabino (THC), is triggered by a pathway that is separate from its other effects. Buy Viagra Sublingual (Sildenafil Citrate) with no Rx The latest findings, published in PLOS Biology, come from a team who previously found that THC reduced tumor growth in cancer patients. Buy Singulair (Montelukast) with no prescription It is hoped the new findings can aid the development of cannabis for medical use, without the risk of its unwanted side effects. Scientists discovered the pathway used for THC involves both a cannabinoid and serotonin receptor. About Colchicine without prescription When blocked, it was discovered THC still exerted several beneficial effects, including pain relief, while also avoiding the impairment of memory, which is a common side effect of cannabis use. Celexa (Citalopram) Researchers undertook behavioral studies in mice and investigating how their brain pathways operate under the effect of THC. Buy Natural Menopause Relief online They found that one serotonin receptor, 5HT2AR, reduced some of the effects of THC - such as its amnesiac effect - but still retained medical benefits, such as pain relief. http://doctoranswers.wordpress.com A study published this year warned of the dangers of a chronic use of cannabis during adolescence with memory problems. The latest study will add further weight to an already highly contested topic. The potential beneficial medical effects and dangers of cannabis use has rarely strayed from the public s eye. Twenty-three US States and the District of Columbia have already passed legislation allowing the use of cannabis for medical use. Furthermore, Oregon has recently become the fourth US State, after Alaska, Colorado and Washington, to legalize the drug for recreational use, and studies are increasingly delving further into the full effects of the drug. Dr. Peter McCormick from UEA s School of Pharmacy, stated this research is important for future development of treatment as it identifies THC s unwanted side effects while maintaining pain reduction. However, Dr. McCormick was quick to warn of the dangers of individuals self-medicating, but stated he hopes the research would lead to a "safe synthetic equivalent being available in the future." Written by Peter Lam

Epilepsy 'increases risk of death' among pregnant women

Pregnant women may have greater risk of adverse complications and death during delivery if they have epilepsy, according to a new study published in JAMA Neurology. Researchers found pregnant women with epilepsy are at greater risk of maternal death and delivery complications than those without the disorder. Epilepsy is brain disorder characterized by abnormal nerve cell activity that causes seizures. Amaryl (Glimepiride) with no prescription It is estimated that around 3 million adults and children in the US have the condition, with around 150,000 new cases diagnosed each year. According to the study researchers, including Sarah MacDonald of the Harvard T.H. Buy Xenical (Orlistat) with free Rx Chan School of Public Health in Boston, MA, around 0.3-0.5% of all pregnancies occur among women with epilepsy. While it is understood that epilepsy can raise the risk of pregnancy- and delivery-related complications, such as fetal injury and preterm birth, MacDonald and colleagues note that there is inadequate data quantifying these risks. "With approximately half a million women with epilepsy of reproductive age in the US, and 25,000 offspring born to these women annually, there is considerable need to understand the risks of pregnancy in this population," they note. The researchers set out to address this data gap, analyzing the hospital records of almost 4.2 million women in the US who gave birth between 2007 and 2011. About DDAVP (Desmopressin) without prescription Of these women, 14,151 had epilepsy. Applying these figures nationwide, the researchers say their study represents 69,385 women with epilepsy and 20,449,532 women without the condition. Incidence of delivery complications was recorded, including Cesarean delivery, preterm birth, preeclampsia, stillbirth and maternal death, and length of hospital stay was also assessed. 10-fold greater risk of maternal death for women with epilepsy The researchers found that the rate of maternal death was much higher among women with epilepsy than those without. There was a rate of 6 deaths per 100,000 pregnancies among women without the brain disorder, while there were 80 deaths per 100,000 pregnancies for women with epilepsy - representing more than a 10-fold greater risk of maternal death. In addition, the team found women with epilepsy were at greater risk of other complications, including preterm labor, preeclampsia and stillbirth. Buy Clomipramine without prescription These women were also more likely to need Cesarean delivery and have longer hospital stays than those without epilepsy. While the researchers are unsure exactly why women with epilepsy are at higher risk of delivery complications and maternal death, they say their findings are of concern: "Regardless of the specific cause, the point that women recorded as having epilepsy have an increased risk of mortality remains a clinically relevant message suggesting that increased attention should be paid. The disproportionate burden of maternal morbidity and mortality among women with epilepsy suggests that these are high-risk patients who may best be cared for in medical centers with subspecialty expertise in neurology, maternal-fetal medicine and critical care." They add that further research is needed to determine the mechanisms underlying their findings and to identify interventions that might improve pregnancy outcomes for women with epilepsy. In an editorial linked to the study, Dr. About Cialis Strong Pack-30 () without Rx Jacqueline A. Buy Mixed Tocopherols online French, of the NYU Langone School of Medicine in New York, NY, and Dr. http://future-pharmaceuticals.blogspot.com Kimford Meador, of the Stanford University School of Medicine, CA, say the findings from MacDonald and colleagues "provide important new information" about pregnancy risks for women with epilepsy. They note, however, that the study raises more questions than it provides answers. "Most WWE [women with epilepsy] have uncomplicated pregnancies," they add. "We need to understand the mechanisms underlying these risks, including death, so that we can identify the specific population at risk and devise interventions to reduce these risks. Future studies need to confirm and build on the present findings to improve the care of WWE during pregnancy." In January, a study published in the journal Neurology claimed people with epilepsy who sleep on their stomach may be at greater risk of sudden unexpected death than those who sleep in other positions. Written by Honor Whiteman

Molecule found that helps BRCA gene resist cancer treatment

. http://doctorconsult.wordpress.com n a new study they report in the journal Molecular Cell, scientists describe how they identified a small molecule that helps the BRCA2 gene do its job. Levitra Soft (Vardenafil) BRCA2 is a tumor suppressor gene that in some mutated forms can cause breast and ovarian cancer in as many as 60% of women. The researchers say understanding how cancer cells repair DNA breaks will help develop new ways to counter resistance to chemotherapy. Like normal cells, cancer cells need to repair DNA to survive. Buy Apcalis Oral Jelly (Tadalafil) with no Rx This is somewhat of a paradox - in their case, they are concerned with maintaining the integrity of "faulty" DNA. DNA repair in cells - both healthy and cancerous - is controlled by genes, including BRCA genes. Decades ago, scientists discovered that variants of BRCA1 and BRCA2 genes are markers for increased risk of breast cancer. Buy Dulcolax (Bisacodyl) without prescription According to the National Cancer Institute, together, BRCA1 and BRCA2 mutations account for about 20-25% of hereditary breast cancers and about 5-10% all breast cancers. About Ciclohale with no prescription In addition, mutations in these genes account for around 15% of all ovarian cancers. Breast and ovarian cancers involving BRCA1 and BRCA2 mutations tend to develop earlier in life than their non-hereditary counterparts. BRCA mutations are also known to play a role in ovarian, prostate and pancreatic cancers. While chemotherapy drugs can be effective for fighting cancer in people with BRCA mutations, there is a tendency for the cancer to develop resistance to the drugs. Buy Dramamine (Dimenhydrinate) with free Rx The BRCA proteins develop secondary mutations that continue to promote cancer growth. Findings point to a way to counter drug resistance in BRCA cancers Now, scientists at Yale School of Medicine in New Haven, CT, have pinpointed a key molecule called co-factor DSS1 that helps the BRCA2 gene to repair DNA. They note how "DSS1 acts as a DNA mimic," and without it, BRCA2 mutations cannot do their job of repairing DNA - which is key to the survival of cancer cells. The team says the findings point to a possible way to decrease drug resistance in cancers involving BRCA genes. Senior author Patrick Sung, a professor of molecular biophysics and biochemistry, suggests drugs that interfere with DSS1 function could be developed and used with existing drugs to overcome this resistance, and explains: "We can design specific targets for drug development only if we fully understand the key players and how they work in the pathway for repairing DNA breaks." Grants from the National Institutes of Health helped fund the study. Meanwhile, Medical News Today recently learned about new research that suggests daily aspirin may prevent breast cancer development and recurrence. Buy Liquid Cold & Flu online Researchers writing in the journal Laboratory Investigation describe how daily low-dose aspirin almost halved tumor growth in mice with breast cancer. Written by Catharine Paddock PhD

Preclinical trial data brings new hope for HIV vaccine

Publishing data from preclinical trials in nonhuman primates in the journal Science, Crucell Holland B.V, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, reveal encouraging results for their HIV vaccine. "Our ultimate goal is to develop a vaccine that prevents HIV in the first place," says Dr. Zyvox (Linezolid) with free prescription Paul Stoffels of Johnson & Johnson. "Despite great progress in HIV treatments," says Dr. Avelox (Moxifloxacin) with no prescription Paul Stoffels, chief scientific officer and worldwide chairman of pharmaceuticals at Johnson & Johnson, "HIV remains one of the greatest global health threats of our time with millions continuing to be infected each year." "Our ultimate goal is to develop a vaccine that prevents HIV in the first place," Dr. Buy Revia (Naltrexone) without prescription Stoffels continues. About Cerazette without Rx "By Janssen collaborating with multiple stakeholders on new tools, we hope one day to help eradicate HIV." Repeated attempts to develop an effective HIV vaccine over the past 30 years have so far been unsuccessful. Buy Epivir (Lamivudine) with free prescription Previously, Medical News Today has looked at studies examining the reasons why experimental HIV vaccines are famously prone to "backfiring." However, last month, Science and the journal Cell published the results from studies investigating an immunogen that may be effective as the first in a series of immunizations against HIV. Buy Kidney Problems online This immunogen, called eOD-GT8 60mer, was designed by a team at The Scripps Research Institute s International AIDS Vaccine Initiative. Risk of infection per exposure estimated to be 100-fold lower Speaking to NBC News about the new vaccine, Hanneke Schuitemaker, vice president in charge of developing viral vaccines at drug company Janssen, said that "based on epidemiological data, we estimate that the risk of a person to become infected per exposure is about 100-fold lower." According to the results of the preclinical trial, the vaccine provided "complete protection" to the 12 nonhuman primate trial subjects from becoming infected with simian immunodeficiency virus (SIV) - the nonhuman primate equivalent of HIV. http://webmd-board.blogspot.com The primates were each exposed to the virus six times. The study results suggest there is also a strong link between the vaccine s protective ability and the number of antibody functions to fight the virus. The vaccine developers cite this "polyfunctionality" as evidence that the vaccine may be effective in human subjects. "We are very encouraged by the results of this preclinical HIV vaccine study, and the findings lead to a clear path forward for evaluating this HIV vaccine candidate in humans," says lead author Dr. Dan H. Barouch, PhD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and professor of medicine at Harvard Medical School, both in Boston, MA. Currently, 400 volunteers are being recruited in the US and Rwanda for a phase 1 trial of the vaccine in humans. Different components of the vaccine are also currently being evaluated in ongoing phase 1 clinical studies. However, this has not been the only big piece of HIV vaccine news this week. HIV vaccine researcher jailed for falsifying data On Wednesday, The Washington Post reported that a former Iowa State University researcher, Dong Pyou Han, had been jailed for falsifying HIV vaccine research. Han spiked rabbit blood with human antibodies, which gave a false impression that the rabbits in his team s studies were mounting an immune response that was neutralizing the HIV virus they were infected with. Han began spiking the rabbit blood in 2008, reportedly to cover up the accidental contamination of blood samples. However, it was not until 2013 - when Harvard researchers attempted to validate the team s results - that human antibodies were discovered in the samples, which unraveled the deception. Sentenced to 4 and a half years in prison, Han has also been ordered to repay the $7.2 million in federal government grant funds that his team received using the falsified results. He has also been banned for pursuing federal research grants for 3 years. Written by David McNamee

Gilead reicht bei US-amerikanischer Food and Drug Administration Zulassungsantrag f"ur Einzeltabletten-HIV-Therapie mit Rilpivirin, Emtricitabin und Tenofovir Alafenamid (R/F/TAF) als neues Arzneimittel ein

FOSTER CITY, Kalifornien--(BUSINESS WIRE)--Das Unternehmen Gilead Sciences, Inc. Buy Truvada (Tenofovir Emtricitabine) without Rx (NASDAQ: GILD) hat heute bekanntgegeben, dass es bei der US-amerikanischen Food and Drug Administration (FDA) einen Zulassungsantrag (New Drug Application, NDA) f"ur ein Einzeltablettenprogramm mit einmal t"aglicher Verabreichung eingereicht hat. About Clomid (Clomiphene) without prescription Emtricitabin 200 mg und Tenofovir Alafenamid (TAF) 25 mg von Gilead werden dabei mit Rilpivirin 25 mg (R/F/TAF) von Janssen Sciences Ireland UC, einem der Janssen Pharmaceutica Unternehmen von Johnson & Johnson, kombiniert. About Acai berry () with free Rx Damit sollen Infektionen mit HIV-1 bei erwachsenen Patienten und Jugendlichen ab zw"olf Jahren behandelt werden. Buy Carbamazepine with no Rx Die mit der NDA eingereichten Daten unterst"utzen die Gabe von R/F/TAF bei Patienten, die HIV-behandlungsunerfahren oder virologisch unterdr"uckt sind und ihr aktuelles antiretrovirales Behandlungsprogramm wechseln wollen. Eine von Knight Therapeutics im November 2014 erhaltene Zusage f"ur ein Vorrangverfahren wurde zusammen mit der NDA f"ur R/F/TAF bei der FDA eingereicht. Buy Herbal Max Gun Power () Gem"ass dem Prescription Drug User Fee Act (PDUFA) liegt das erwartete Zieldatum f"ur die NDA f"ur R/F/TAF sechs Monate nach der Annahme der Einreichung durch die FDA. „R/F/TAF ist die dritte TAF-basierte Einreichung von Gilead in weniger als einem Jahr, und wir freuen uns darauf, Menschen, die mit HIV leben, eine weitere effektive Behandlungsoption mit g"unstigem Sicherheitsprofil anbieten zu k"onnen”, sagte Dr. Buy Hair Vitamins online Norbert Bischofberger, Executive Vice President Forschung und Entwicklung und Chief Scientific Officer bei Gilead Sciences. http://webmdhelp.wordpress.com „Die R/F/TAF-Einreichung stellt ausserdem die n"achste Kooperation von Gilead mit Janssen im Rahmen unserer gemeinsamen Bestrebungen dar, die HIV-Behandlung f"ur bestimmte Patienten zu verst"arken und eventuell zu verbessern.” TAF ist ein neuartiger, in der Erprobungsphase befindlicher NRTI (nukleosidischer reverser Transkriptasehemmer), der in klinischen Studien eine hohe antivirale Wirksamkeit bei einer zehnmal geringeren Dosis als Viread® (Tenofovirdisoproxilfumarat, TDF) von Gilead, sowie verbesserte Nieren- und Knochenwerte im Labor gegen"uber TDF in Kombination mit anderen antiretroviralen Wirkstoffen ergeben hat. Ausser R/F/TAF befinden sich auch zwei weitere HIV-Therapien auf TAF-Basis im Pr"ufverfahren bei der FDA. Im November 2014 reichte Gilead eine NDA f"ur ein Einzeltablettenprogramm mit einmal t"aglicher Verabreichung bestehend aus Elvitegravir 150 mg, Cobicistat 150 mg, Emtricitabin 200 mg und TAF 10 mg (E/C/F/TAF) ein. Im April 2015 reichte Gilead eine weitere NDA f"ur zwei Dosen eines Pr"ufpr"aparats mit einer festen Dosis einer Kombination aus Emtricitabin und Tenofovir Alafenamid (200/10 mg und 200/25 mg) (F/TAF) f"ur die Gabe in Kombination mit anderen antiretroviralen Wirkstoffen gegen HIV ein. Gem"ass dem PDUFA hat die FDA als erwartetes Zieldatum f"ur E/C/F/TAF den 5. November 2015 und f"ur F/TAF den 7. April 2016 gesetzt. Die Antr"age auf Marktzulassung in der Europ"aischen Union wurden f"ur E/C/F/TAF am 23. Dezember 2014 und f"ur F/TAF am 28. Mai 2015 vollst"andig validiert. Gilead plant, im dritten Quartal 2015 einen Zulassungsantrag f"ur R/F/TAF in der Europ"aischen Union einzureichen. Der aktuelle NDA wird durch eine Bio"aquivalenzstudie unterst"utzt, mit der bewiesen wurde, dass mit R/F/TAF die gleichen Emtricitabin- und TAF-Wirkstoffspiegel im Blut erzielt werden, wie mit E/C/F/TAF (TAF-Dosierung von 10 mg), und die gleichen Rilpivirin-Wirkstoffspiegel, wie nur mit einer 25 mg Dosis Rilpivirin (Edurant®). Die Sicherheit und Wirksamkeit von TAF wird durch eine Reihe klinischer Studien bei verschiedenen HIV-Patienten unterst"utzt, darunter behandlungsunerfahrenen Erwachsenen und Heranwachsenden, virologisch unterdr"uckten Erwachsenen, die die Therapie gewechselt haben, sowie Erwachsenen mit leichten bis mittelschweren Nierenfunktionsst"orungen. Im Rahmen von Studien f"uhrte eine TAF-basierte Behandlung (als E/C/F/TAF gegeben) zu keiner geringeren Wirksamkeit und zu verbesserten Nieren- und Knochenwerten gegen"uber einer TDF-basierten Therapie im Labor (verabreicht als E/C/F/TDF oder Stribild®®). Die R/F/TAF-Einreichung ist der aktuellste Schritt im Rahmen einer erweiterten Entwicklungs- und Vermarktungsvereinbarung zwischen Gilead und Janssen, die 2009 begr"undet wurde. Laut dieser Vereinbarung und vorbehaltlich der Zulassung des Produktes wird Gilead f"ur die Herstellung und Registrierung, den Vertrieb und die Vermarktung des Arzneimittelregimes in den meisten L"andern zust"andig sein. Janssen wird es auf etwa 17 M"arkten vertreiben und Mitinhaber der Herstellungsrechte f"ur einige zentrale M"arkte wie die Vereinigten Staaten sein. Die Vereinbarung wurde erstmals f"ur die Entwicklung und Vermarktung von Complera® geschlossen. Dieses Medikament wird in der Europ"aischen Union unter der Bezeichnung Eviplera® vermarktet. Ein viertes Programm auf TAF-Basis mit TAF, Emtricitabin und Cobicistat von Gilead, sowie Darunavir (D/C/F/TAF) von Janssen, befindet sich unter einer anderen Lizenzvereinbarung ebenfalls in der Entwicklung. Im Rahmen der Vereinbarung "ubertr"agt Gilead die Weiterentwicklung des Arzneiregimes sowie, vorbehaltlich der beh"ordlichen Zulassung, die Herstellung, Registrierung, den Vertrieb und die Vermarktung des Produkts weltweit an Janssen. Medikamente auf TAF-Basis sind Pr"ufpr"aparate, deren Wirksamkeit und Vertr"aglichkeit noch nicht nachgewiesen wurde. "Uber Gilead Sciences Gilead Sciences ist ein Biopharmaunternehmen, das innovative Arzneimittel f"ur medizinische Bereiche erforscht, entwickelt und vermarktet, in denen ungedeckter Bedarf besteht. Das Unternehmen hat es sich zur Aufgabe gemacht, die Versorgung lebensbedrohlich erkrankter Patienten zu verbessern. Gilead ist in "uber 30 L"andern weltweit t"atig und hat seinen Hauptsitz in Foster City im US-Bundesstaat Kalifornien. Zukunftsgerichtete Aussagen Diese Pressemitteilung enth"alt zukunftsgerichtete Aussagen im Sinne des Private Securities Litigation Reform Act von 1995, die Risiken, Ungewissheiten und anderen Faktoren unterliegen, wie etwa dem Risiko, dass es Gilead nicht gelingt, innerhalb des angestrebten Zeitrahmens einen Zulassungsantrag f"ur R/F/TAF bei der Europ"aischen Union einzureichen. Des Weiteren k"onnten die Genehmigungen f"ur F/TAF, E/C/F/TAF, R/F/TAF, D/C/F/TAF und andere auf F/TAF basierende Medikamente seitens der FDA und anderer Aufsichtsbeh"orden nicht innerhalb des derzeit erwarteten Zeitrahmens eingehen oder auch ganz ausbleiben, und Marktzulassungen k"onnten, falls sie gew"ahrt werden, signifikanten Beschr"ankungen in der Verwendung unterliegen. Das Ergebnis k"onnte sein, dass F/TAF, E/C/F/TAF, R/F/TAF, D/C/F/TAF und andere Medikamente auf F/TAF-Basis nie erfolgreich vermarktet werden. Diese Risiken, Unsicherheiten und anderen Faktoren k"onnten dazu f"uhren, dass tats"achliche Ergebnisse wesentlich von den im Rahmen der zukunftsgerichteten Aussagen in Aussicht gestellten Resultaten abweichen. Die Leser werden darauf hingewiesen, sich nicht ungeb"uhrlich auf diese zukunftsgerichteten Aussagen zu verlassen. Einzelheiten zu diesen und weiteren Risiken sind im Jahresbericht von Gilead auf Formblatt 10-Q f"ur das am 31. M"arz 2015 zu Ende gegangene Quartal enthalten, der bei der US-B"orsenaufsichtsbeh"orde SEC (Securities and Exchange Commission) eingereicht worden ist. Alle zukunftsgerichteten Aussagen beruhen auf Informationen, die Gilead gegenw"artig vorliegen, und das Unternehmen "ubernimmt keine Verpflichtung zur Aktualisierung solcher zukunftsgerichteter Aussagen. Die vollst"andigen Verschreibungsinformationen zu Viread, Complera und Stribild f"ur die USA, einschliesslich einer BLACK-BOX-WARNUNG, finden sich unter .gilead.com. Edurant ist ein eingetragenes Warenzeichen von Johnson & Johnson oder verbundenen Unternehmen. Viread, Complera, Stribild und Eviplera sind eingetragene Warenzeichen von Gilead Sciences, Inc., oder verbundenen Unternehmen. Weitere Informationen zu Gilead Sciences erhalten Sie auf der Website des Unternehmens unter .gilead.com. Folgen Sie Gilead auf Twitter (@GileadSciences) oder wenden Sie sich an die Gilead-Abteilung f"ur "offentliche Angelegenheiten unter 1-800-GILEAD-5 oder 1-650-574-3000. Die Ausgangssprache, in der der Originaltext ver"offentlicht wird, ist die offizielle und autorisierte Version. "Ubersetzungen werden zur besseren Verst"andigung mitgeliefert. Nur die Sprachversion, die im Original ver"offentlicht wurde, ist rechtsg"ultig. Gleichen Sie deshalb "Ubersetzungen mit der originalen Sprachversion der Ver"offentlichung ab.

Testosterone therapy the hormone debate rages on

As people age, they often encounter new health problems. Buy Truvada (Tenofovir Emtricitabine) without Rx One of the challenges for men and women growing older is how these changes are dealt with, including navigating the world of treatment options that are often available. Low testosterone can lead to erectile dysfunction, reduced sexual desire and infertility. When men get older, many notice significant differences in their sex drive, weight, emotion and energy levels. About Clomid (Clomiphene) without prescription These changes, often occurring when men reach their late 40s and early 50s, have prompted comparison with the female menopause. Sometimes these changes are attributed to reduced levels of testosterone - the male sex hormone produced predominantly by the testes. About Acai berry () with free Rx Men with reduced testosterone levels can experience benefits with testosterone therapy, with many physicians able to prescribe replacement testosterone in the form of injections, patches, pellets and gels. However, the use of testosterone therapy is fiercely debated - particularly when low testosterone levels are associated with age - with clinicians concerned about when treatment is appropriate and what its risks and benefits are. In this Spotlight feature, we have a look at circumstances that might warrant the use of testosterone therapy and investigate different viewpoints from both sides of the current debate. The male menopause One major aspect of the debate is how the drop in testosterone is discussed. Buy Carbamazepine with no Rx In many news stories, the terms "male menopause" and "andropause" are used on account of the fact that most of the symptoms associated with declining testosterone levels are similar to those caused by the female menopause. Low testosterone can lead to changes in sexual function, including reduced sexual desire, erectile dysfunction and fewer spontaneous erections. Buy Herbal Max Gun Power () Other physical changes that can occur include increased body fat, decreased bone density and hot flashes. Emotional changes can also occur, such as a decrease in motivation and self-confidence, as can sleep disturbances such as insomnia. However, the timeframe over which these changes occur is a major difference between what is experienced by women and many men. Buy Hair Vitamins online Whereas the female hormone levels fall over a short period of time, male testosterone levels typically decline gradually over a period of many years. Dr. http://webmdhelp.wordpress.com Abraham Morgentaler, an associate clinical professor of urology at Harvard Medical School in Boston, MA, told Medical News Today that the terms are problematic in that they set up a parallel with the female menopause that is obviously incorrect. However, he believes the terms do have some use. "On the other hand, what is valuable about these terms is that they convey to the public a condition that has strong similarities to something they already know, making it easier to understand," he explained. Testosterone levels decline in men as they grow old as part of the aging process, typically falling by around 1% each year after men enter their 30s. However, testosterone levels can also fall as part of a disease known as hypogonadism, caused by a problem with the testicles or pituitary gland. Central to the debate over using testosterone therapy to treat perceived symptoms of hypogonadism is whether or not observed biological changes are a result of a decline in hormone concentrations caused by reproductive system pathology or merely the result of aging (aging-related hypogonadism) or other conditions, such as thyroid problems and alcohol use. Testosterone therapy can reverse the effects of hypogonadism. However, the use of testosterone therapy in otherwise healthy men who are experiencing symptoms caused by reduced levels of testosterone is subject to passionate debate. "Unfortunately, passion clouds our ability to assess the evidence on testosterone objectively," warns Dr. Morgentaler in an article published on Medscape. Is testosterone therapy dangerous? Dr. Morgentaler believes that testosterone treatment can benefit patients reporting symptoms associated with reduced levels of testosterone even when there is no documented cause for hypogonadism, such as a pituitary tumor. "Deficiencies of hormones, such as testosterone, produce certain symptoms," he writes. "The effect is the same whether an underlying cause is identified or not. Imagine limiting antihypertensive therapy to the minority of men with known causes. This makes no sense." An argument for limiting testosterone therapy is a perceived risk of cardiovascular events among men receiving testosterone. Earlier this year, the US Food and Drug Administration (FDA) updated testosterone product labels to detail a possible increased risk of heart attacks and stroke. Supporters state that testosterone therapy is a proven effective treatment and that cardiovascular risks are overstated. The FDA recommend that physicians should only prescribe testosterone therapy for men with low testosterone levels caused by disorders of the testicles, pituitary gland or brain that cause hypogonadism. Prior to this announcement, however, Dr. Morgentaler and colleagues conducted a systematic review of available literature on testosterone and cardiovascular risks. They found only four studies reported negative concerns while many others suggested several positives, including reduced mortality, increased exercise capacity and improvement in cardiovascular risk factors such as fat mass. In summary, the researchers concluded that there is no convincing evidence of increased cardiovascular risks with testosterone therapy and, on the contrary, there could be a beneficial relationship between cardiovascular health and normal testosterone levels. "Although no large, long-term controlled studies have definitively determined risk, the weight of evidence right now strongly favors the [cardiovascular] benefits of having a normal serum testosterone concentration, whether achieved naturally or with testosterone therapy," Dr. Morgentaler writes. Overall, there is evidence demonstrating that testosterone therapy can improve symptoms - both sexual and nonsexual - in most men, and Dr. Morgentaler holds that general health may also be improved in symptomatic users. "Testosterone therapy is good medicine for the appropriate patient," he writes. "There is value in identifying men who are testosterone-deficient, and offering them a trial of treatment. For the good of men, it is high time to restore the primacy of science to the field of testosterone deficiency." This form of treatment is increasingly seen as valuable, by patients and clinicians alike. An estimated 2 million men in the US are currently being treated with testosterone, with the number of prescriptions rising steeply over the past decade. In an article originally published in the Journal of the American Geriatrics Society, Dr. Thomas Perls and David J. Handelsman, PhD, describe the increases in prescriptions in detail: "US pharmaceutical sales of testosterone increased from $324 million in 2002 to $2 billion in 2012, and the number of testosterone doses prescribed climbed from 100 million in 2007 to half a billion in 2012, not including the additional contributions from compounding pharmacies, Internet, and direct-to-patient clinic sales." Accusations of disease mongering Dr. Morgentaler states that the reasons for this rise are an increased awareness of testosterone deficiency among health care providers and assuaged fears around an early association between testosterone therapy and prostate cancer. Critics of testosterone therapy, however, believe that other forces are at work. In their paper, Dr. Perls and Prof. Handelsman state that 10- and 40-fold increases reported in the US and Canada are partly attributable to direct-to-consumer product advertising and lax consensus guidelines. "We join others who characterize the mass marketing of testosterone coupled with the permissive prescribing of testosterone for common, nonspecific, aging-related symptoms as disease mongering of declines in testosterone with advancing age," they write. Critics believe that guidelines incorporating nonspecific symptoms such as increased weariness have been drawn up to increase the scope of testosterone therapy. Dr. Perls, based in the Department of Medicine at Boston Medical Center, MA, told MNT that the evidence suggests that pharmaceutical marketing is the predominant reason that testosterone therapy has become as prevalent as it has, stating that aging-related hypogonadism did not exist as a condition to be diagnosed before 2000. "It emerged once the pharmaceutical companies and other doctor and Internet-based entrepreneurs sensed a big profit opportunity by greatly expanding the market for testosterone by making up a new disease consisting of a decreased testosterone level [...] combined with nonspecific common symptoms," he said. "Instead of the 0.5% of men previously noted by endocrinologists to have hypogonadism, there are now clinics and doctors claiming that 40-100% of men experience hypogonadism that merits testosterone replacement." Symptoms such as decreased sexual desire, depressed mood and decreased exertion tolerance can be the result of common problems such as obesity and smoking, which also cause a functional decline in testosterone. "Replacing testosterone in these cases is medically inappropriate and, rather, steps should be taken to treat the underlying cause," he said. In the example of obesity, more apt treatment methods include diet and exercise which do not carry the same risks as those identified by the FDA for testosterone therapy. Co-author Prof. Handelsman, of the ANZAC Research Institute at the University of Sydney in Australia, believes that, at present, we do not know enough about naturally declining testosterone levels to automatically classify them as a deficiency. Regarding cases of testosterone decline in men not associated with reproductive medical disorders, Prof. Handelsman told MNT: "In these situations lower circulating testosterone is not a deficiency at all. This thinking confuses a genuine deficiency state due to pathological reproductive system disorders with a normal functional, adaptive hypothalamic reaction to a systemic disease - which may be beneficial, neutral or harmful." Critics of the wide use of testosterone therapy believe that varying guidelines have been created that stretch the definition of hypogonadism to incorporate nonspecific age-related symptoms which in turn increase the scope of the treatment, making it easier for clinicians to prescribe. "Without demonstrated underlying reproductive system pathology, a set of common complaints plus or minus a low serum testosterone cannot constitute hypogonadism, " write the authors. The FDA currently require the demonstration of a pathological basis for growth hormone deficiency before a prescription for growth hormone can be dispensed. Dr. Perls and Prof. Handelsman believe that a similar demonstration of pathology should be required for the prescription of testosterone. The debate continues On the one hand, testosterone therapy is a form of treatment that can improve various symptoms experienced by some men as they grow older. On the other hand, testosterone therapy is a means to profit from disease mongering. For supporters of testosterone therapy like Dr. Morgentaler, the results speak for themselves. "Indeed," he writes "one only needs to treat five symptomatic men with low testosterone values to become convinced: two will thank the physician profusely for restoring their sexuality and vitality, another two will report solid benefits, and one will not respond." Prof. Handelsman believes that further research is needed. "That point requires proper evaluation, not wild guesswork by pharma or single-issue proponents who have vested interests in such drug promotion," he told MNT. Both sides of the debate present their own evidence and refute that of the opposition, putting the lay person who lacks expertise in a tricky position when it comes to making a judgment. The Mayo Clinic recommend discussing any signs and symptoms that could be attributed to a low testosterone level with a doctor. Being honest with health care providers, making healthy lifestyle choices and seeking help when feeling down are useful steps in tackling problems associated with aging and may help with any decision making about pursuing treatment. It is likely that the debate surrounding testosterone therapy and aging-related hypogonadism will continue into the near future. For any patients affected by these topics, it would appear best to keep an open mind and listen to both sides of the debate while further research is conducted. Written by James McIntosh

Testosterone therapy the hormone debate rages on

As people age, they often encounter new health problems. Buy Truvada (Tenofovir Emtricitabine) without Rx One of the challenges for men and women growing older is how these changes are dealt with, including navigating the world of treatment options that are often available. Low testosterone can lead to erectile dysfunction, reduced sexual desire and infertility. When men get older, many notice significant differences in their sex drive, weight, emotion and energy levels. About Clomid (Clomiphene) without prescription These changes, often occurring when men reach their late 40s and early 50s, have prompted comparison with the female menopause. Sometimes these changes are attributed to reduced levels of testosterone - the male sex hormone produced predominantly by the testes. About Acai berry () with free Rx Men with reduced testosterone levels can experience benefits with testosterone therapy, with many physicians able to prescribe replacement testosterone in the form of injections, patches, pellets and gels. However, the use of testosterone therapy is fiercely debated - particularly when low testosterone levels are associated with age - with clinicians concerned about when treatment is appropriate and what its risks and benefits are. In this Spotlight feature, we have a look at circumstances that might warrant the use of testosterone therapy and investigate different viewpoints from both sides of the current debate. The male menopause One major aspect of the debate is how the drop in testosterone is discussed. Buy Carbamazepine with no Rx In many news stories, the terms "male menopause" and "andropause" are used on account of the fact that most of the symptoms associated with declining testosterone levels are similar to those caused by the female menopause. Low testosterone can lead to changes in sexual function, including reduced sexual desire, erectile dysfunction and fewer spontaneous erections. Buy Herbal Max Gun Power () Other physical changes that can occur include increased body fat, decreased bone density and hot flashes. Emotional changes can also occur, such as a decrease in motivation and self-confidence, as can sleep disturbances such as insomnia. However, the timeframe over which these changes occur is a major difference between what is experienced by women and many men. Buy Hair Vitamins online Whereas the female hormone levels fall over a short period of time, male testosterone levels typically decline gradually over a period of many years. Dr. http://webmdhelp.wordpress.com Abraham Morgentaler, an associate clinical professor of urology at Harvard Medical School in Boston, MA, told Medical News Today that the terms are problematic in that they set up a parallel with the female menopause that is obviously incorrect. However, he believes the terms do have some use. "On the other hand, what is valuable about these terms is that they convey to the public a condition that has strong similarities to something they already know, making it easier to understand," he explained. Testosterone levels decline in men as they grow old as part of the aging process, typically falling by around 1% each year after men enter their 30s. However, testosterone levels can also fall as part of a disease known as hypogonadism, caused by a problem with the testicles or pituitary gland. Central to the debate over using testosterone therapy to treat perceived symptoms of hypogonadism is whether or not observed biological changes are a result of a decline in hormone concentrations caused by reproductive system pathology or merely the result of aging (aging-related hypogonadism) or other conditions, such as thyroid problems and alcohol use. Testosterone therapy can reverse the effects of hypogonadism. However, the use of testosterone therapy in otherwise healthy men who are experiencing symptoms caused by reduced levels of testosterone is subject to passionate debate. "Unfortunately, passion clouds our ability to assess the evidence on testosterone objectively," warns Dr. Morgentaler in an article published on Medscape. Is testosterone therapy dangerous? Dr. Morgentaler believes that testosterone treatment can benefit patients reporting symptoms associated with reduced levels of testosterone even when there is no documented cause for hypogonadism, such as a pituitary tumor. "Deficiencies of hormones, such as testosterone, produce certain symptoms," he writes. "The effect is the same whether an underlying cause is identified or not. Imagine limiting antihypertensive therapy to the minority of men with known causes. This makes no sense." An argument for limiting testosterone therapy is a perceived risk of cardiovascular events among men receiving testosterone. Earlier this year, the US Food and Drug Administration (FDA) updated testosterone product labels to detail a possible increased risk of heart attacks and stroke. Supporters state that testosterone therapy is a proven effective treatment and that cardiovascular risks are overstated. The FDA recommend that physicians should only prescribe testosterone therapy for men with low testosterone levels caused by disorders of the testicles, pituitary gland or brain that cause hypogonadism. Prior to this announcement, however, Dr. Morgentaler and colleagues conducted a systematic review of available literature on testosterone and cardiovascular risks. They found only four studies reported negative concerns while many others suggested several positives, including reduced mortality, increased exercise capacity and improvement in cardiovascular risk factors such as fat mass. In summary, the researchers concluded that there is no convincing evidence of increased cardiovascular risks with testosterone therapy and, on the contrary, there could be a beneficial relationship between cardiovascular health and normal testosterone levels. "Although no large, long-term controlled studies have definitively determined risk, the weight of evidence right now strongly favors the [cardiovascular] benefits of having a normal serum testosterone concentration, whether achieved naturally or with testosterone therapy," Dr. Morgentaler writes. Overall, there is evidence demonstrating that testosterone therapy can improve symptoms - both sexual and nonsexual - in most men, and Dr. Morgentaler holds that general health may also be improved in symptomatic users. "Testosterone therapy is good medicine for the appropriate patient," he writes. "There is value in identifying men who are testosterone-deficient, and offering them a trial of treatment. For the good of men, it is high time to restore the primacy of science to the field of testosterone deficiency." This form of treatment is increasingly seen as valuable, by patients and clinicians alike. An estimated 2 million men in the US are currently being treated with testosterone, with the number of prescriptions rising steeply over the past decade. In an article originally published in the Journal of the American Geriatrics Society, Dr. Thomas Perls and David J. Handelsman, PhD, describe the increases in prescriptions in detail: "US pharmaceutical sales of testosterone increased from $324 million in 2002 to $2 billion in 2012, and the number of testosterone doses prescribed climbed from 100 million in 2007 to half a billion in 2012, not including the additional contributions from compounding pharmacies, Internet, and direct-to-patient clinic sales." Accusations of disease mongering Dr. Morgentaler states that the reasons for this rise are an increased awareness of testosterone deficiency among health care providers and assuaged fears around an early association between testosterone therapy and prostate cancer. Critics of testosterone therapy, however, believe that other forces are at work. In their paper, Dr. Perls and Prof. Handelsman state that 10- and 40-fold increases reported in the US and Canada are partly attributable to direct-to-consumer product advertising and lax consensus guidelines. "We join others who characterize the mass marketing of testosterone coupled with the permissive prescribing of testosterone for common, nonspecific, aging-related symptoms as disease mongering of declines in testosterone with advancing age," they write. Critics believe that guidelines incorporating nonspecific symptoms such as increased weariness have been drawn up to increase the scope of testosterone therapy. Dr. Perls, based in the Department of Medicine at Boston Medical Center, MA, told MNT that the evidence suggests that pharmaceutical marketing is the predominant reason that testosterone therapy has become as prevalent as it has, stating that aging-related hypogonadism did not exist as a condition to be diagnosed before 2000. "It emerged once the pharmaceutical companies and other doctor and Internet-based entrepreneurs sensed a big profit opportunity by greatly expanding the market for testosterone by making up a new disease consisting of a decreased testosterone level [...] combined with nonspecific common symptoms," he said. "Instead of the 0.5% of men previously noted by endocrinologists to have hypogonadism, there are now clinics and doctors claiming that 40-100% of men experience hypogonadism that merits testosterone replacement." Symptoms such as decreased sexual desire, depressed mood and decreased exertion tolerance can be the result of common problems such as obesity and smoking, which also cause a functional decline in testosterone. "Replacing testosterone in these cases is medically inappropriate and, rather, steps should be taken to treat the underlying cause," he said. In the example of obesity, more apt treatment methods include diet and exercise which do not carry the same risks as those identified by the FDA for testosterone therapy. Co-author Prof. Handelsman, of the ANZAC Research Institute at the University of Sydney in Australia, believes that, at present, we do not know enough about naturally declining testosterone levels to automatically classify them as a deficiency. Regarding cases of testosterone decline in men not associated with reproductive medical disorders, Prof. Handelsman told MNT: "In these situations lower circulating testosterone is not a deficiency at all. This thinking confuses a genuine deficiency state due to pathological reproductive system disorders with a normal functional, adaptive hypothalamic reaction to a systemic disease - which may be beneficial, neutral or harmful." Critics of the wide use of testosterone therapy believe that varying guidelines have been created that stretch the definition of hypogonadism to incorporate nonspecific age-related symptoms which in turn increase the scope of the treatment, making it easier for clinicians to prescribe. "Without demonstrated underlying reproductive system pathology, a set of common complaints plus or minus a low serum testosterone cannot constitute hypogonadism, " write the authors. The FDA currently require the demonstration of a pathological basis for growth hormone deficiency before a prescription for growth hormone can be dispensed. Dr. Perls and Prof. Handelsman believe that a similar demonstration of pathology should be required for the prescription of testosterone. The debate continues On the one hand, testosterone therapy is a form of treatment that can improve various symptoms experienced by some men as they grow older. On the other hand, testosterone therapy is a means to profit from disease mongering. For supporters of testosterone therapy like Dr. Morgentaler, the results speak for themselves. "Indeed," he writes "one only needs to treat five symptomatic men with low testosterone values to become convinced: two will thank the physician profusely for restoring their sexuality and vitality, another two will report solid benefits, and one will not respond." Prof. Handelsman believes that further research is needed. "That point requires proper evaluation, not wild guesswork by pharma or single-issue proponents who have vested interests in such drug promotion," he told MNT. Both sides of the debate present their own evidence and refute that of the opposition, putting the lay person who lacks expertise in a tricky position when it comes to making a judgment. The Mayo Clinic recommend discussing any signs and symptoms that could be attributed to a low testosterone level with a doctor. Being honest with health care providers, making healthy lifestyle choices and seeking help when feeling down are useful steps in tackling problems associated with aging and may help with any decision making about pursuing treatment. It is likely that the debate surrounding testosterone therapy and aging-related hypogonadism will continue into the near future. For any patients affected by these topics, it would appear best to keep an open mind and listen to both sides of the debate while further research is conducted. Written by James McIntosh

Ruxolitinib is useful for long-term treatment of polycythemia vera

Patients with polycythemia vera who continue treatment with ruxolitinib for up to 80 weeks appear to have durable hematocrit control and reductions in spleen volume, investigators announced at the 20th Congress of the European Hematology Association. Data from the new study support ruxolitinib as an effective long-term treatment option for patients with polycythemia vera. "Our data support ruxolitinib as an effective long-term treatment option for patients with [polycythemia vera (PV)] who have had an inadequate response to or who are unable to tolerate conventional hydroxyurea treatment," Jean-Dr. About Sinequan (Doxepin) with free Rx Jacques Kiladjian, professor of clinical pharmacology at Paris Diderot University in Paris, France, said. About Diovan (Valsartan) with no prescription Dr. Buy Super Pack () with no Rx Kiladjian and colleagues conducted a pre-planned analysis of the global, phase 3 RESPONSE study in order to determine the long-term efficacy and safety of ruxolitinib after all patients completed the week 80 visit or withdrew from the study. Bystolic without prescription Ruxolitinib is a Janus kinase 1 and 2 inhibitor. In the study, 222 patients who were intolerant or resistant to hydroxyurea were randomized to open-label ruxolitinib 10 mg BID or best available therapy (BAT). About Kamagra Polo (Sildenafil) with no Rx Best available therapy included hydroxyurea (at a dose that did not cause unacceptable side effects), interferon or pegylated interferon, pipobroman, anagrelide, immunomodulators such as lenalidomide or thalidomide, or no medication. Buy General Brain Formulas online Patients randomized to BAT could cross over to ruxolitinib from week 32. http://webmdconsult.wordpress.com Hydroxyurea is the most commonly used first-line cytoreductive agent, Dr. Kiladjian pointed out. Although many PV patients have an adequate response to hydroxyurea, about 25% of patients have unacceptable side effects or an inadequate response, and alternative treatment options are needed for these patients. He also noted that some patients have a high symptom burden that may include itching, fatigue and night sweats, which respond poorly to standard therapies. At the data cut-off for the 80-week analysis, 82.7% of patients randomized to ruxolitinib were still receiving treatment (with a median exposure of 111 weeks) compared to no patient in the BAT arm. The composite primary endpoint of both hematocrit control without phlebotomy through week 32 and a >= 35% reduction from baseline in spleen volume by imaging at week 32 occurred in a significantly higher percent of patients in the ruxolitinib group than in the BAT group (20.9% vs 0.9%). Overall, 60.0% of ruxolitinib patients versus 19.6% of BAT patients achieved hematocrit control without phlebotomy through week 32; patients achieving hematocrit control in the ruxolitinib arm had an 89% probability of maintaining this response for 80 weeks from the time of their initial response. Of patients on ruxolitinib at week 32, 89.8% did not have a phlebotomy between weeks 32 and 80. At week 32, 38.2% versus 0.9% of patients in the ruxolitinib versus BAT arm achieved a >=35% reduction in spleen volume; all ruxolitinib patients maintained their response. At week 32, complete hematologic remission was achieved in 23.6% of ruxolitinib patients and 8.9% of BAT patients, with ruxolitinib responders having a 69% probability of maintaining complete hematologic remission for 80 weeks. A separate analysis at 18 months showed that ruxolitinib treatment also resulted in sustained control of white blood cell and platelet levels, with the largest decreases in patients with the highest baseline levels. Ruxolitinib generally remained well tolerated. Most adverse events were grade 1 or 2, and there were few grade 3 or 4 cytopenias. As reported in a prior analysis, the rate of herpes zoster was higher in the ruxolitinib arm. The RESPONSE study was conducted at 90 sites worldwide. Written by Jill Stein