Tuesday, September 16, 2014

Thrasos annonce que l’analyse interm'ediaire et la revue des donn'ees l’'etude clinique de phase II sur le THR-184 pour le traitement de l’insuffisance r'enale aig"ue m`ene `a des recommandations favorables


MONTR EAL--(BUSINESS WIRE)--Thrasos Therapeutics, entreprise de produits bioth erapeutiques qui vise `a offrir de nouvelles solutions de traitement des maladies r enales, a annonc e aujourd’hui que l’analyse interm ediaire, planifi ee des 140 premiers sujets inclus dansl’ etude clinique de phase II sur le THR-184 pour le traitement de l’insuffisance r enale aig"ue a eu lieu. L’ etude se poursuit et la strat egie posologique sera ajust ee selon les recommandations du comit e de surveillance des donn ees sur l’innocuit e (CSDI). `A l’heure actuelle, 200 sujets ont et e admis dans cet essai clinique. L’analyse interm ediaire a et e r ealis ee par une equipe ind ependante de statisticiens et examin ee par le CSDI. About Diflucan (Fluconazole) with free prescription Elle porte sur l’innocuit e et l’efficacit e de trois doses initiales de THR-184 compar ees `a un placebo. Dilantin (Phenytoin) Le CSDI a recommand e la poursuite de l’ etude en conservant le groupe recevant la dose initiale elev ee, et l’interruption des deux groupes recevant une dose inf erieure. Detrol La (Tolterodine) with free Rx Thrasos poursuivra l’ etude conform ement aux recommandations du CSDI et ajoutera un groupe qui recevra une dose plus elev ee en post-op eratoire, ce qui augmentera le nombre total de sujets de l’ etude `a environ 450. « Je suis heureux que le CSDI ait pu compl eter son evaluation de l’innocuit e et de l’efficacit e potentielle du THR-184 `a ce stade de l’ essai de phase II, et je suis particuli`erement satisfait de la recommandation du comit e de poursuivre l’enr^olement ds sujets dans l’ etude, vu le profil d’innocuit e de THR-184 », a d eclar e Glenn Chertow, professeur de m edecine et chef du d epartement de n ephrologie de l’ ecole de m edecine de l’Universit e Stanford. Le THR-184 est un petit peptide qui agit sur la voie des BMP et des SMAD. Buy Desent Il est en d eveloppement pour la pr evention et le traitement de l’insuffisance r enale aig"ue. Buy Snoring online En effet, les r esultats d’un vaste ensemble d’ etudes pr ecliniques, ainsi que ceux de deux essais cliniques de phase I dans le cadre desquels le THR-184 s’est r ev el e s^ur et bien tol er e, ont men e `a la mise en place d’un important essai clinique de phase II. http://cholesterolreviews.wordpress.com Jusqu’`a 450 patients r epartis dans plus de 40 centres au Canada et aux Etats-Unis devraient ^etre admis `a l’essai clinique. L’essai porte sur la pr evention de l’insuffisance r enale aig"ue chez les patients apr`es chirurgie cardiaque. Au d ebut de l’ann ee, la Food and Drug Administration des Etats-Unis a accord e la d esignation « Fast Track » (proc edure d’ evaluation acc el er ee) au THR-184 pour cette indication. « L’incidence de l’insuffisance r enale aig"ue `a la suite d’une chirurgie cardiaque est un grave probl`eme pour les patients et les m edecins; le potentiel du THR-184 dans la pr evention de cette complication est tr`es prometteur », a affirm e Jean-Claude Tardiff, directeur du Centre de recherche de l’Institut de cardiologie de Montr eal affili e `a l’Universit e de Montr eal et copr esident du comit e d’ etude. « Les r esultats positifs de l’analyse interm ediaire repr esentent une etape importante dans l’avancement du programme afin de mieux comprendre le potentiel de ce traitement. » « Nous sommes tr`es satisfaits de la progression de l’ etude de phase II. L’entreprise a travaill e en etroite collaboration avec les experts faisant partie du comit e directeur afin d’arriver `a ce stade. De plus, l’essai a et e concu avec soin afin d’ evaluer l’innocuit e, la tol erabilit e et l’efficacit e de diff erentes doses de THR-184 », a expliqu e Jens Eckstein, Ph. D., pr esident, SR One et pr esident du conseil d’administration de Thrasos. « Nous sommes impatients de passer `a l’ etape suivante du programme d’essai de phase II. » `A propos de l’insuffisance r enale aig"ue L’insuffisance r enale aig"ue est la d et erioration soudaine de la fonction r enale et touche plus de 1,2 million de personnes chaque ann ee aux Etats-Unis. Elle survient dans diff erentes situations et est particuli`erement fr equente chez les patients hospitalis es en raison d’une chirurgie lourde, notamment une chirurgie cardiaque ou vasculaire, d’un traumatisme, d’une infection, d’une maladie cardiaque ou d’un cancer. L’insuffisance r enale aig"ue peut se solder par une alt eration permanente de la fonction r enale et peut egalement ^etre associ ee `a une augmentation du risque de d ec`es, `a une hospitalisation prolong ee et `a une augmentation consid erable des frais m edicaux. `A l’heure actuelle, il n’existe aucun moyen de pr evenir ni de traiter l’insuffisance r enale aig"ue. `A propos de Thrasos Thrasos est une entreprise priv ee de produits bioth erapeutiques au stade clinique, qui vise `a offrir de nouvelles solutions aux personnes atteintes de maladie r enale. Le compos e phare de l’entreprise, le THR-184, fait actuellement l’objet d’une etude clinique de phase II sur la pr evention de l’insuffisance r enale aig"ue apr`es chirurgie cardiaque. Thrasos travaille egalement `a la mise au point de compos es visant `a traiter la n ephropathie diab etique, une cause majeure de maladie r enale chronique. .thrasos.com

Monday, August 4, 2014

Sensient Technologies Corporation Announces CFO Transition


MILWAUKEE--(BUSINESS WIRE)--Sensient Technologies Corporation (NYSE: SXT) today announced that Dick Hobbs will retire from his role as Senior Vice President and Chief Financial Officer in February 2015 and that he will be succeeded by Stephen Rolfs, Sensient’s current Senior Vice President, Administration. Mr. Hobbs has been Sensient’s Chief Financial Officer since July 2000. He joined the Company in 1973. About Cipro (Ciprofloxacin) without Rx “Dick has been instrumental to the success of Sensient,” said Paul Manning, President and CEO of Sensient. Clarinex (Desloratadine) with free prescription “The Company would not be where it is today without Dick’s financial and strategic leadership. Buy Cialis Soft (Tadalafil) without prescription We cannot thank him enough for all he has done.” Stephen Rolfs joined Sensient in 1997. Buy Dds without Rx Prior to assuming his current role as Senior Vice President, Administration, Mr. Buy Rutin online Rolfs was Sensient’s Controller and Chief Accounting Officer. http://cholesterolreviews.wordpress.com He has also served as Sensient’s Treasurer and its Vice President, Corporate Development. Prior to joining Sensient, he was employed by Brown-Forman Corporation, a beverage and consumer products company, as a financial analyst and as Assistant Vice President. From 1986 to 1991 Mr. Rolfs worked as a CPA for the public accounting firm of Ernst & Young. He holds a Bachelor s degree in Accounting from the University of Notre Dame and an MBA from the University of Chicago. “Steve brings leadership skills, financial experience, and a deep knowledge of our business to the role,” said Paul Manning. “His expertise will be critical in helping the Company deliver value-enhancing growth over the coming years.” ABOUT SENSIENT TECHNOLOGIES Sensient Technologies Corporation is a leading global manufacturer and marketer of colors, flavors and fragrances. Sensient employs advanced technologies at facilities around the world to develop specialty food and beverage systems, cosmetic and pharmaceutical systems, inkjet and specialty inks and colors, and other specialty and fine chemicals. The Company’s customers include major international manufacturers representing most of the world’s best-known brands. Sensient is headquartered in Milwaukee, Wisconsin. .sensient.com

Tuesday, July 29, 2014

Research and Markets Global Market Report of Amantadine


. http://cholesterolreviews.wordpress.com Buy Azulfidine (Sulfasalazine) DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/7xzhdt/global_market) has announced the addition of the "Global Market Report of Amantadine" report to their offering. Global Market Report of Amantadine (CAS 768-94-5) aims at providing comprehensive data on Amantadine globally and regionally (Europe, Asia, North America, Latin America etc.). Buy Azelex (Azelaic Acid) without prescription It captures Amantadine market trends, pays close attention to Amantadine This report focuses on three primary areas; manufacture methods & technology development, market situation & trend analysis, and distribution policy. The first section centres on manufacture methods & technology development and the main manufacture methods of are introduced. Cyclomune with free Rx The detailed production techniques section covers technical principle, technical flow, technical process, facilities, post allocation, cost estimation, environmental protection, technical features, product quality standards and project feasibility study conclusions. The second section focuses on the market situation & trend analysis. Buy Potassium online Azelex (Azelaic Acid) It looks at application and end products, the production situation, manufacturers & capacity statistics, market supply status & trend forecast, production statistics & trend analysis, downstream consumer market analysis, supply & demand analysis, price analysis, and import & export situation for the chemical in question. The final section looks at the distribution policy; it looks at the major use segments, the consumers and the traders for the chemical in question. Please note, delivery for this product may take up to 3 business days from receipt of payment. Key Topics Covered: Part 1: Introduction of Amantadine Part 2: Manufacture Methods and Technology Development of Amantadine Part 3: Application of Amantadine Part 4: Production Situation of Amantadine Part 5: Market Situation of Amantadine Part 6: Distribution Policy of Amantadine Part 7: Reference For more information visit .researchandmarkets.com/research/7xzhdt/global_market

Thursday, July 24, 2014

Simulations Plus to Acquire Cognigen Corporation


LANCASTER, Calif.--(BUSINESS WIRE)--Simulations Plus, Inc. (NASDAQ:SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced that it has entered into an Agreement and Plan of Merger (the “Agreement”) with Cognigen Corporation of Buffalo, New York. Pursuant to the Agreement, upon closing, Cognigen will become a wholly-owned subsidiary of Simulations Plus and will continue to operate under the Cognigen name. This will result in the total number of Simulations Plus employees increasing from 30 to 65, and is expected to add approximately $5 million to the revenues of the combined company in the coming fiscal year. Walt Woltosz, chairman and chief executive officer of Simulations Plus, Inc., said, “This is an exciting step forward for both Simulations Plus and Cognigen. Azelex (Azelaic Acid) Upon closing, management of the combined company will be comprised of individuals from the current management teams of Simulations Plus and Cognigen, including Ted Grasela, the current President of Cognigen. Buy Azulfidine (Sulfasalazine) I will remain as Chairman and CEO.” Woltosz continued, “Ted has extensive experience in modeling and simulation, clinical pharmacology, and outcomes research. Buy Azelex (Azelaic Acid) without prescription Ted and his partners, Cynthia Walawander and Jill Fiedler-Kelly, have built Cognigen over more than 20 years into a profitable industry leader in high-quality analysis of clinical trial data, serving customers ranging from top-5 pharmaceutical companies to numerous mid- and smaller-size organizations. Cyclomune with free Rx Their advanced systems and processes provide cost-effective support for model-based research and development. Buy Potassium online These systems and the work of their dedicated scientists and support staff have earned Cognigen a worldwide reputation for the quality and reliability of their work.” Ted Grasela said, “Simulations Plus has been a pioneer in the use of modeling and simulation in pharmaceutical research and development since 1996. http://cholesterolreviews.wordpress.com The company has built a comprehensive suite of software that provides best-in-class tools spanning from early discovery through preclinical and early clinical development, and on to post-patent development of generic formulations. By combining the strengths of the two companies, we will be able to better address the recent push by regulatory agencies to include more physiologically based pharmacokinetics modeling, a strength of Simulations Plus, into clinical trial analysis, a strength of Cognigen. I look forward to Walt’s continuing guidance and mentorship as we move into a new and exciting phase of our company’s growth.” The Agreement The Agreement calls for the merger of Cognigen with and into a wholly-owned subsidiary of Simulations with the subsidiary continuing as the surviving corporation. The closing date of the proposed merger is anticipated to be September 2, 2014, and the Agreement requires approval by the Board of Directors of both Simulations Plus and Cognigen. Under the terms of the Agreement, Simulations Plus will pay the shareholders of Cognigen total consideration of $7,000,000, comprised of $2,800,000 of cash and $4,200,000 worth of newly-issued, unregistered shares of common stock of Simulations Plus. The Agreement provides that $1,800,000 of the total consideration will be held back for two years to satisfy any indemnifiable claims that may arise pursuant to the terms of the Agreement. Excel Partners, an investment bank with offices in New York and Los Angeles, acted as exclusive financial advisor to Simulations Plus in connection with this transaction. About Simulations Plus, Inc. Simulations Plus, Inc., is a premier developer of groundbreaking drug discovery and development simulation and modeling software that is licensed to and used in the conduct of drug research by major pharmaceutical, biotechnology, agrochemical, and food industry companies worldwide. Simulations Plus is headquartered in Southern California and trades on the NASDAQ Capital Market under the symbol “SLP.” For more information, visit our Web site at .simulations-plus.com. About Cognigen Corporation Cognigen Corporation was founded in 1993 in Buffalo, New York and has grown to become one of the leading providers of clinical trial data analysis. The services of the company are well-recognized as providing analysis and reports that are tailored to the expectations of regulatory agencies so that reports are submitted in a manner that minimizes follow-up questions from regulators, saving sponsors considerable time and money in getting new pharmaceutical products to market. More information is available on the company’s Web site at .cognigencorp.com. Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect” and “anticipate” mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to properly manage the new combined company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports as filed with the U.S. Securities and Exchange Commission.

Wednesday, July 23, 2014

Statement from Herbalife in Response to Bill Ackman's Three-Hour Presentation on Nutrition Clubs


LOS ANGELES--(BUSINESS WIRE)--Herbalife Ltd. (NYSE:HLF) today issued the following statement in response to Bill Ackman’s three-hour presentation on the Company’s nutrition clubs: Herbalife is a 34-year old nutrition company with 7,400 employees worldwide and millions of members. Today, Mr. Adalat Cc (Nifedipine) with free Rx Ackman highlighted many of the reasons we are proud of our company, our record and the value we bring to members, consumers and communities around the world. Advair Diskus (Fluticasone-Salmeterol) with no prescription His presentation reaffirmed that: Herbalife is first and foremost a company with great products that people want. There are hundreds of thousands of members and millions more consumers who choose Herbalife for our products and community-based approach to health and wellness. There is a comprehensive training system for members who aspire to open their own nutrition club so that they are fully informed of the time, commitment and skills required to do so. Once again, Bill Ackman has over-promised and under-delivered on his $1 billion bet against our company. Buy Advair Diskus (Fluticasone, Salmeterol) with free Rx After spending $50 million, two years and tens of thousands of man-hours, Bill Ackman further demonstrated today that the facts are on our side. We will continue to focus on our mission of bringing good nutrition and economic opportunities to communities across the globe. About Corbis without prescription We recognize that he is running out of time to make good on his bad bet against Herbalife, with the equivalent of 25.7 million shares in put options that expire on January 17, 2015. Buy Organic Shampoo online Today is evidence that Bill Ackman will not succeed. To clarify, a couple of points: We are proud that our members are required to participate in training before deciding to open a nutrition club. http://cholesterolreviews.wordpress.com Our training approach – sometimes referred to as a “university” – is similar to the training model that has been deployed by numerous consumer-facing companies. Club 100 was a program that contained many of the best elements of nutrition clubs, including education, mentoring and fiscal responsibility. These elements are the cornerstone of our clubs today. Herbalife is proud of our members who use nutrition clubs as an important tool of social support to achieve good nutrition and a healthy active lifestyle. Mr. Ackman’s claim about the earnings of Herbalife nutrition clubs is completely false and fabricated. In fact, according to a recent study commission by the Company, 87.5% of nutrition club operators feel good about the money they earn and 92% want to continue with their club. In a separate release, Herbalife today released the findings from research and analysis conducted by Walter H. A. Vandaele, Ph.D. of Navigant Economics, LLC regarding Herbalife’s U.S. business operations. Dr. Vandaele, engaged by the Company to conduct this economic analysis, assessed whether Herbalife’s operations appropriately are classified as a beneficial, legitimate Multi-Level Marketing (“MLM”) firm. Dr. Vandaele is an economic expert with significant experience in, among other areas, the regulation and operations of firms in the consumer goods industry. Among his many professional accomplishments, he has previously served as Economic Advisor to the Director, Bureau of Competition and as Assistant Director for Regulatory Evaluation, Bureau of Consumer Protection at the U.S. Federal Trade Commission (“FTC”). Among his numerous determinations, Dr. Vandaele concluded that, “Herbalife’s U.S. business operations are consistent with the socially beneficial MLM model and inconsistent with the socially harmful pyramid scheme model.” About Herbalife Ltd. Herbalife Ltd. (NYSE:HLF) is a global nutrition company that sells weight-management, nutrition and personal care products intended to support a healthy lifestyle. Herbalife products are sold in more than 90 countries to and through a network of independent Members. The company supports the Herbalife Family Foundation and its Casa Herbalife program to help bring good nutrition to children. Herbalife s website contains a significant amount of financial and other information about the company at ir.Herbalife.com. The company encourages investors to visit its website from time to time, as information is updated and new information is posted.

Friday, July 18, 2014

Terumo BCT ouvre une installation de production au Vietnam


LAKEWOOD, Colorado--(BUSINESS WIRE)--Terumo BCT, un chef de file mondial en mati`ere de technologies cellulaires, de composants sanguins et d’aph er`ese th erapeutique, a annonc e aujourd’hui l’ouverture d’un nouveau site de 91 440 m`etres carr es `a proximit e d’Ho Chi Minh-Ville, au Vietnam. La nouvelle installation, qui repr esente un montant de 100 millions USD, s’inscrit dans la lign ee de la politique adopt ee par Terumo BCT, qui souhaite etendre ses activit es mondiales. Lorsque les activit es d emarreront au d ebut de l’ann ee 2015, le nouveau site de fabrication permettra `a l’entreprise de b en eficier d’une capacit e de production accrue. Faits cl es : Terumo BCT est un fabricant global de dispositifs m edicaux dont le si`ege social est bas e `a Lakewood, dans le Colorado La soci et e poss`ede egalement des bureaux r egionaux `a : Bruxelles, Buenos Aires, Hong Kong et Tokyo Avec un investissement de 100 millions USD, Terumo BCT a construit une installation 91 440 m`etres carr es pr`es d’Ho Chi Minh-Ville, le tout sur une superficie de dix hectares Une fois que la dotation en personnel sera compl`ete, le b^atiment devrait accueillir plus de 900 nouveaux collaborateurs Apr`es l’ouverture du site vietnamien, les produits de Terumo BCT seront fabriqu es dans sept pays : Belgique, Chine, Inde, Japon, Irlande du Nord, Etats-Unis et Vietnam Les sacs de sang total et les produits jetables destin es aux collectes automatiques seront fabriqu es au Vietnam Terumo BCT compte actuellement plus de 4 800 collaborateurs et la soci et e dessert trois principaux segments de client`ele dans plus de 120 pays et territoires : banques de sang, aph er`ese th erapeutique et collecte de cellules, et traitement des cellules L’installation vietnamienne fait partie de la strat egie globale de Terumo BCT qui pr evoit des investissements dans ses sites de fabrication d ej`a existants aux Etats-Unis au niveau de son si`ege mondial dans le Colorado, et dans ses installations de fabrication en Irlande du Nord et en Inde Citations cl es : Craig Rinehardt, vice-pr esident ex ecutif des op erations mondiales, Terumo BCT « L’ach`evement de la construction de cette usine de fabrication illustre notre engagement continu envers nos clients de tous les continents, car en proposant une capacit e globale et en faisant evoluer les techniques de fabrication qui seront utilis ees au Vietnam, nous allons pouvoir r eduire les d elais de mise sur le march e et am eliorer notre capacit e `a r epondre aux besoins de nos clients. Buy Zyvox (Linezolid) with no Rx » « En moins d’un an, nous avons pr epar e le terrain, commenc e les travaux et termin e la construction. Cialis Daily (Tadalafil) Avec l’aide de tant de personnes, nous avons fait fructifier notre investissement, et nous sommes ravis d’ouvrir aujourd’hui les portes de notre usine de fabrication vietnamienne, laquelle constitue un d eveloppement bienvenu pour notre si`ege social am ericain de fabrication, et pour nos activit es mondiales. About Vytorin (Simvastatin, Ezetimibe) with free prescription » Yutaro Shintaku, pr esident et directeur d el egu e de Terumo Corporation « La nouvelle installation de Terumo BCT au Vietnam est le plus r ecent exemple de la facon dont Terumo Corporation investit dans ses capacit es `a l’ echelle mondiale, et l’ouverture de ce site constitue une nouvelle etape importante pour nous. Clopress with no prescription Nous sommes optimistes quant aux possibilit es de cette nouvelle installation qui devrait nous permettre de participer `a la croissance de la r egion et de r ealiser notre mission qui est de contribuer `a la soci et e par le biais des soins de sant e. Buy Mullein online » Ressources cl es : Photos du site - Vietnam 2014 D emarrage des travaux - Vietnam 2013 Investissement de Terumo BCT dans le Colorado Investissement de Terumo BCT en Irlande du Nord `A propos de Terumo BCT : Terumo BCT, un chef de file mondial en mati`ere de technologies cellulaires, de composants sanguins et d’aph er`ese th erapeutique, est la seule soci et e `a offrir une combinaison unique de collectes d’aph er`ese, de traitement du sang total manuel et automatis e et de r eduction des pathog`enes. http://cholesterolreviews.wordpress.com Nous sommes convaincus que le sang est capable de faire encore plus pour les patients que ce n’est le cas aujourd’hui. C’est cette conviction qui inspire nos innovations et qui nous pousse `a renforcer notre collaboration avec les clients. Le texte du communiqu e issu d’une traduction ne doit d’aucune mani`ere ^etre consid er e comme officiel. La seule version du communiqu e qui fasse foi est celle du communiqu e dans sa langue d’origine. La traduction devra toujours ^etre confront ee au texte source, qui fera jurisprudence.

Thursday, July 17, 2014

Neue im Rahmen der Alzheimer’s Association International Conference pr"asentierte Studien belegen diagnostischen Wert von [18F] Flutemetamol von GE Healthcare


KOPENHAGEN, D"anemark--(BUSINESS WIRE)--Die neuen, heute im Rahmen der Alzheimer’s Association International Conference® 2014 (AAIC®) vorgestellten Studienergebnisse belegen, dass ein positiver Befund eines [18F] Flutemetamol PET-Scans im Hinblick auf Amyloid-Ablagerungen im Gehirn ein hochgradig signifikanter Pr"adiktor f"ur den "Ubergang von einer amnestischen leicht kognitiven St"orung (Mild Cognitive Impairment, aMCI) zu einer vermuteten Alzheimer-Erkrankung (pAD) ist.1 Eine zweite Studie belegte dar"uber hinaus den diagnostischen Wert von [18F] Flutemetamol f"ur den Nachweis des Vorhandenseins von Amyloid-Ablagerungen an Nervenzellen bei fr"uhzeitig an Demenz erkrankten Patienten.2 [18F] Flutemetamol ist das radiopharmazeutische Pr"ufpr"aparat von GE Healthcare f"ur PET-Bildgebungsverfahren zum Nachweis von Beta-Amyloid-Ablagerungen an Nervenzellen in den Gehirnen erwachsener Patienten mit kognitiven Beeintr"achtigungen, die im Hinblick auf eine Alzheimer-Erkrankung oder andere Ursachen kognitiver St"orungen untersucht werden. „Insgesamt zeigen diese Ergebnisse den diagnostischen Wert von [18F] Flutemetamol und liefern zus"atzliche Hinweise, dass Flutemetamol die "Arzte bei histopathologischen Untersuchungen im Rahmen von Alzheimer-Diagnosen bei spezifischen Patienten unterst"utzen kann”, so Ger Brophy, PhD, Chief Technology Officer, Life Sciences bei GE Healthcare. „Nach seiner Zulassung in der Europ"aischen Union wird [18F] Flutemetamol ein wichtiges Instrument zur Unterst"utzung der Beurteilung von Patienten mit kognitiven Beeintr"achtigungen und dar"uber hinaus ein wertvolles Forschungsinstrument bei der Suche nach Therapieformen zur Bek"ampfung von Alzheimer-Erkrankungen darstellen.” Nutzung von [18F] Flutemetamol PET-Scans als Pr"adiktor f"ur den "Ubergang einer amnestischen leicht kognitiven St"orung zu einer vermuteten Alzheimer Erkrankung Im Rahmen der Studie erhielten 232 Patienten mit MCI und kognitiven Defiziten, die den Alltag der Patienten nicht entscheidend beeintr"achtigen, und die daher nicht als dement galten, eine [18F] Flutemetamol-Injektion und wurden Gehirn-Scans unterzogen. Die Studie zeigte, dass Patienten mit positiven VIZAMYL-Scans mit einer 2,5-fach h"oheren Wahrscheinlichkeit den "Ubergang zu einer vermuteten Alzheimer-Erkrankung vollziehen als jene mit negativen Scan-Ergebnissen. About Diflucan (Fluconazole) with free prescription Die Verwendbarkeit positiver [18F] Flutemetamol PET-Bilder bei der Identifizierung von aMCI-Patienten, die mit einer h"oheren Wahrscheinlichkeit den "Ubergang zu einer vermuteten Alzheimer-Erkrankung vollziehen werden, k"onnte eine bessere Patientenevaluierung und –versorgung nach sich ziehen und die Patientenstratifizierung bei der Rekrutierung f"ur klinische Studien zu krankheitsmodifizierenden Medikamenten erleichtern. „Diese Ergebnisse veranschaulichen die potenzielle Rolle von [18F] Flutemetamol bei der Stratifizierung von Patienten, die mit h"oherer Wahrscheinlichkeit an Alzheimer erkranken, "uber die Verwendung als Diagnoseinstrument hinaus”, so David Wolk, MD, Assistant Director am Penn Memory Center und Forschungsleiter der Studie. Dilantin (Phenytoin) „"Uber die Bereitstellung potenziell wichtiger Informationen "uber die Wahrscheinlichkeit zu einem sp"ateren Zeitpunkt an Demenz zu erkranken hinaus, k"onnte die Identifizierung von Hochrisikopatienten die "Arzte unterst"utzen, verl"assliche Empfehlungen f"ur die Patienten"uberwachung auszusprechen, Versorgungspl"ane aufzustellen und geeignete Diagnoseinstrumente auszuw"ahlen. Detrol La (Tolterodine) with free Rx Dies sind hervorragende Ergebnisse. Buy Desent Aber dennoch sind weitere Forschungen notwendig, um vollst"andig zu verstehen, wie diese Ergebnisse in der klinischen Praxis am besten umgesetzt werden k"onnen.” Diagnostischer Wert von [18F] Flutemetamol bei fr"uhzeitiger Demenz Im Rahmen dieser Studie wurden 80 Patienten mit fr"uhzeitiger Demenz (j"unger als 70 Jahre) und einer "arztlichen Diagnosesicherheit von weniger als 90 % [18F] Flutemetamol PET-Scans unterzogen, die entweder positive oder negative Amyloid-Befunde aufwiesen. Buy Snoring online Die klinischen Diagnoseverfahren und die Diagnosesicherheit wurden sowohl vor als auch nach der Offenlegung der Scan-Ergebnisse festgelegt. http://cholesterolreviews.wordpress.com Die Studie konnte zeigen, dass die Verwendung von [18F] Flutemetamol die Diagnosesicherheit aufseiten der "Arzte verbessern half und bei vielen Patienten dazu beitragen konnte, die Diagnose einer Alzheimer-Erkrankung zu best"atigen oder auszuschliessen und "Anderungen der Patientenversorgung zu bewirken. „Fr"uhzeitige und pr"azise Diagnosen k"onnen sich sowohl auf die Prognosen als auch auf die Behandlung von Patienten mit fr"uhzeitiger Demenz auswirken”, erkl"arte Dr. Marissa Zwan, VU University Medical Center, Amsterdam und Forschungsleiter der Studie. „Eine h"ohere Diagnosesicherheit f"uhrt zu einer besseren Patientenversorgung, unterst"utzt die "Arzte, geeignete Behandlungsformen auszuw"ahlen und erleichtert Patienten und Betreuern die Planung f"ur die Zukunft.” Die Ergebnisse zeigten, dass 20 % der Patienten im Anschluss an die "Uberpr"ufung eines [18F] Flutemetamol-Scans eine andere Diagnose erhielten. Insbesondere bei jenen Patienten, die vor einem [18F] Flutemetamol-Scan eine Alzheimer-Diagnose und zus"atzlich einen negativen Amyloid-Befund erhielten, "anderte sich die klinische Diagnose in 12 von 15 F"allen. Insgesamt erh"ohte sich die Diagnosesicherheit nach der Offenlegung der PET-Resultate signifikant von 67 (±12) Prozent auf 90 (±16) Prozent. Dar"uber hinaus f"uhrten die [ 18F] Flutemetamol PET-Befunde bei 48 % der Patienten zu einer "Anderung der Patientenversorgung (d.h. Medikationsumstellungen oder zus"atzliche Pflegemassnahmen). Im Oktober 2013 erhielt [18F] Flutemetamol die Zulassung von der US-amerikanischen Arzneimittelbeh"orde FDA (wo auch seine Vermarktung als VIZAMYL™ eingetragen wurde) f"ur PET-Bildgebungsverfahren (Positronenemissionstomographie) zum Aufsp"uren von Beta-Amyloid-Ablagerungen an Nervenzellen im Gehirn erwachsener Patienten mit kognitiven Beeintr"achtigungen, die im Hinblick auf eine Alzheimer-Erkrankung oder andere Ursachen kognitiver St"orungen untersucht werden. VIZAMYL dient lediglich zu Diagnosezwecken und sollte nur in Verbindung mit einer klinischen Evaluierung verwendet werden. VIZAMYL ist noch in keinem Markt zur Bestimmung des Risikos f"ur einen "Ubergang von MCI zu einer klinischen Alzheimer-Erkrankung zugelassen. Im Juni 2014 ver"offentlichte der Ausschuss f"ur Humanarzneimittel (Committee for Medicinal Products for Human Use, CHMP) der Europ"aischen Arzneimittelbeh"orde eine positive Stellungnahme zu [18F] Flutemetamol und sprach eine Empfehlung aus zur Vermarktung f"ur PET-Bildgebungsverfahren zum Aufsp"uren von Beta-Amyloid-Ablagerungen an Nervenzellen im Gehirn erwachsener Patienten mit kognitiven Beeintr"achtigungen, die im Hinblick auf eine Alzheimer-Erkrankung oder andere Ursachen kognitiver St"orungen untersucht werden. Flutemetamol ist noch nicht zur Anwendung in Europa oder Japan zugelassen. GE-FORSCHUNGSARBEIT IM BEREICH BILDGEBUNG [18F] Flutemetamol geh"ort zu einem breiten Portfolio von Diagnosesystemen in Pr"ufstadium, das GE Healthcare derzeit auf dem Gebiet der Neurologie entwickelt. Im Rahmen seiner laufenden Forschungsarbeiten verfolgt das Unternehmen einen umfassenden Ansatz, um Demenz und Alzheimer-Erkrankungen zu verstehen und die Ursachen, Risiken und physischen Auswirkungen der Krankheit aufzudecken. GE Healthcare liefert ein breit gef"achertes Spektrum von Bildgebungssystemen, darunter Zyklotrone und chemische Systeme zur Herstellung von PET-Kontrastmittel sowie PET und MR-Scanner. Gleichzeitig entwickelt das Unternehmen Bildanalyse-Software und stellt damit Instrumente zur Quantifizierung, optimierten Visualisierung und Berichterstellung bereit. Dar"uber hinaus arbeitet GE Healthcare mit der Pharmaindustrie zusammen, um bei der Entwicklung von Therapien der n"achsten Generation zu helfen. Zu diesem Zweck kooperiert GE Healthcare mit potenziellen Partnern der Branche, um mehr "uber ihre strategischen Bed"urfnisse zu erfahren und sie bei der Bereitstellung von Bildgebungsl"osungen f"ur Therapiezulassungsstudien zu unterst"utzen. "UBER GE HEALTHCARE GE Healthcare liefert richtungweisende medizintechnische L"osungen und bietet Dienstleistungen, die einen wichtigen Beitrag zur Verbesserung der Verf"ugbarkeit, Qualit"at und Erschwinglichkeit der Patientenversorgung weltweit leisten. GE (NYSE: GE) setzt sich f"ur massgebende Dinge ein - ausgezeichnetes Personal und leistungsstarke Technologien im Angesicht von schwierigen Herausforderungen. Dank medizinischer Bildgebung, Informationstechnologie, medizinischer Diagnostik, Patienten"uberwachung, Arzneimittelforschung, biopharmazeutischer Fertigungstechnologien und L"osungen zur Leistungsverbesserung hilft GE Healthcare medizinischen Fachkr"aften, eine hervorragende Patientenversorgung bereitzustellen. Neueste Informationen erhalten Sie unter newsroom.gehealthcare.com 1 Wolk DA, Duara R, Sadowsky C, et al. : [18F]Flutemetamol Amyloid PET Imaging: Outcome of Phase III Study in Subjects with Amnestic Mild Cognitive Impairment after 3 Year Follow Up. Ergebnisse wurden im Rahmen der Alzheimer’s Association International Conference® 2014 vorgestellt. 2 Zwan MD, Bouwman FH, Lammertsma AA, et al. Clinical Impact of [18F]Flutemetamol PET in Young Onset Dementia. Ergebnisse wurden im Rahmen der Alzheimer’s Association International Conference® 2014 vorgestellt. 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.

Monday, July 14, 2014

Transplant Genomics Inc. Announces Exclusive License to Patent Rights Co-Owned by The Scripps Research Institute and Northwestern University


BROOKLINE, Mass.--(BUSINESS WIRE)--Transplant Genomics Inc. (TGI) announced that it has obtained an exclusive license to patent rights co-owned by The Scripps Research Institute and Northwestern University that provide the foundation for clinical tests to improve management of organ transplant recipients, with the potential to extend lives and reduce costs of associated healthcare. TGI intends to develop and commercialize tests that use genomic markers of transplant graft status as part of a surveillance program to detect and respond to early signs of graft injury. This licensing agreement provides TGI with access to a broad portfolio of intellectual property related to kidney and liver transplant diagnostics, including immune status monitoring and optimization. Buy Zyvox (Linezolid) with no Rx TGI’s scientific founders, Dr. Cialis Daily (Tadalafil) Michael Abecassis (Northwestern Medicine) and Dr. About Vytorin (Simvastatin, Ezetimibe) with free prescription Daniel Salomon (The Scripps Research Institute), have been recognized for their work on discovery and validation of novel biomarkers of graft and immune status for solid-organ transplants. “The scientific founders of TGI have uniquely combined biomarker discovery with clinical validation and insight to set the stage for high-impact collaborations designed to move the transplant field forward,” explained Stanley Rose, PhD, President & CEO of Transplant Genomics and a kidney transplant recipient. Clopress with no prescription “Working with the transplant community, TGI will bring these vital advances in biomarkers of transplant status from bench to clinic. Buy Mullein online Clinicians will be able to access clear, actionable information to optimize immunosuppression therapy to improve graft survival.” TGI’s first test will be used to routinely monitor kidney transplant recipients, indicating when treatment or biopsy is required based on analysis of a patient’s blood. http://cholesterolreviews.wordpress.com As described in a study involving seven transplant centers recently published in the American Journal of Transplantation,1 peripheral blood gene expression profiling was used to classify kidney graft recipients into three key categories of graft status (acute rejection, acute dysfunction no rejection, and stable graft performance) with very high predictive accuracy. Ongoing prospective studies will reveal how far in advance of dysfunction these signatures can be detected, and whether they can be used to monitor the effectiveness of treatment. The need for such improved tests is highlighted by the fact that more than 15% of kidney transplant patients with normal serum creatinine levels, the most commonly used indicator of graft injury, show signs of rejection when their grafts are analyzed by protocol biopsy up to one year post-transplant.2-4 “TGI’s tests could be used for serial patient monitoring in stable patients with good kidney function to better inform decisions about immunosuppression,” stated Michael Abecassis, MD, MBA, Founding Director and Chief Clinical Advisor of TGI and Founding Director of the Comprehensive Transplant Center at Northwestern University’s Feinberg School of Medicine. “The test will also find a major and immediate application in circumstances where a sudden elevation in creatinine is noted by the clinician and a biopsy is not possible because of logistical issues.” “The danger of subclinical acute organ rejection is well recognized as a significant cause of late graft loss but nearly impossible to diagnose since doing serial biopsies is not feasible,” explained Dan Salomon, MD, Founding Director and Chief Scientific Advisor of TGI and Professor at The Scripps Research Institute. “A minimally invasive blood test could be used to predict clinical rejection, to diagnose subclinical rejection, and to monitor treatment to assure clinicians that the therapy was fully effective.” TGI is committed to making minimally invasive tests commercially available to transplant recipients for this purpose, delivering on the promise of clinical application of biomarker discovery. About Transplant Genomics Inc. Transplant Genomics is a molecular diagnostics company committed to improving organ transplant outcomes. Working with the transplant community, TGI will bring vital advances in diagnosis and prediction of transplant status from bench to clinic, supporting clinicians with clear, actionable information to optimize immunosuppression therapy, enhance patient care and improve graft survival. Tests will be made commercially available through a CLIA lab, with an initial focus on kidney transplantation. For more information, go to .TransplantGenomics.com. 1. Kurian SM, Williams AN, Gelbart T, et al. Molecular classifiers for acute kidney transplant rejection in peripheral blood by whole genome gene expression profiling. Am J Transplant 2014;5(14):1164-1172. 2. Rush D, Somorjai R, Deslauriers R, Shaw A, Jeffery J, Nickerson P. Subclinical rejection—a potential surrogate marker for chronic rejection—may be diagnosed by protocol biopsy or urine spectroscopy. Ann Transplant 2000;5(2):44-49. 3. Moreso F, Ibernon M, Goma M, et al. Subclinical rejection associated with chronic allograft nephropathy in protocol biopsies as a risk factor for late graft loss. Am J Transplant 2006;6(4):747-752. 4. Nankivell BJ. Subclinical renal allograft rejection and protocol biopsies: quo vadis? Nat Clin Pract Nephrol 2008;4(3):134-135.

Thursday, July 10, 2014

TransTech Pharma, LLC Announces Agreement with FDA on Special Protocol Assessment for TTP488 Phase 3 Trial in Patients with Mild Alzheimer’s Disease


HIGH POINT, N.C.--(BUSINESS WIRE)--TransTech Pharma, LLC today announced that it has reached an agreement with the U.S. Food and Drug Administration Division of Neurology Products, under the Special Protocol Assessment (SPA) process, on the design of a single Phase 3 trial of TTP488 for the treatment of patients with mild Alzheimer’s disease. A Special Protocol Assessment (SPA) from the FDA is a binding agreement that the Phase 3 trial design, planned execution and statistical analyses are acceptable to support regulatory approval. Additional information regarding the FDA’s Special Protocol Assessment process may be found at: .fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm080571.pdf. “The agreement on the SPA represents a significant milestone for the development of TTP488 and for TransTech Pharma” said Steve Holcombe, President and CFO. About Neggram (Nalidixic Acid) with no Rx “We are extremely pleased to receive agreement on the SPA and to have a clear path forward for the submission and regulatory approval of TTP488 for the treatment of patients with mild Alzheimer’s disease.” The Phase 3 trial will be a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of TTP488 for the treatment of patients with mild Alzheimer’s disease. Neurontin (Gabapentin) The trial will compare TTP488 5mg daily to placebo over the course of 18 months of treatment. Micronase (Glyburide, Glibenclamide) with no prescription Approximately 800 patients with mild Alzheimer’s disease receiving standard of care (i.e. Cantar with no prescription acetylcholinesterase inhibitors) will be enrolled. Buy Gugul online The primary efficacy analysis will be based on the changes in ADAS-cog (Alzheimer’s Disease Assessment Scale – cognitive subscale) and CDR-sb (Clinical Dementia Rating – sum of boxes). http://mdreview.wordpress.com TransTech Pharma anticipates beginning enrollment of patients before the end of the year. About TTP488 Substantial data suggest that RAGE, the Receptor for Advanced Glycation Endproducts, is involved in the pathogenesis of Alzheimer’s disease, and that sustained Ab interaction with RAGE at the blood-brain barrier (BBB), or in neuronal or microglial cells, is an important element of amyloid plaque formation and chronic neural dysfunction. TTP488 is a novel, small-molecule, orally active antagonist of RAGE. In a double-blind clinical trial where data was collected over 18 months, TTP488 slowed cognitive decline in patients with mild to moderate Alzheimer’s disease. The effect, while evident in both patients with mild and moderate disease, was more prominent in patients with mild disease. TransTech Pharma discovered and developed TTP488 using its proprietary drug discovery platform TTP Translational Technology®. About Alzheimer’s Disease Alzheimer’s disease, the most common form of dementia, is a progressive neurodegenerative disorder that causes decline in cognition and functional abilities. It has been estimated to affect 5 million individuals in the United States, and represents the 6th leading cause of death. Worldwide, there are currently more than 35 million people with dementia, and the number is predicted to increase to over 115 million by 2050. While current approved therapies for Alzheimer’s disease focus on improving the symptoms of the cognitive dysfunction, there is currently no treatment to slow disease progression. About TransTech Pharma, LLC TransTech Pharma, LLC is a privately held, clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of human therapeutics to fill unmet medical needs. The Company’s high-throughput drug discovery platform, Translational Technology®, translates the functional modulation of human proteins into safe and effective medicines. TransTech Pharma, LLC has a pipeline of small-molecule clinical and pre-clinical drug candidates for the treatment of a wide range of human diseases, including central nervous system disorders, diabetes, obesity, cardiovascular disease, inflammation and cancer. For further company information, visit .ttpharma.com.

Wednesday, July 9, 2014

Taro Annual Report For Fiscal Year Ended March 31, 2014 on Form 20-F Available


. About Lamisil (Terbinafine) with free prescription HAWTHORNE, N.Y.--(BUSINESS WIRE)--Taro Pharmaceutical Industries Ltd. About Buspin without Rx (NYSE: TARO, “Taro”) announced that its Annual Report for fiscal year ended March 31, 2014 on Form 20-F, filed with the Securities and Exchange Commission (the “SEC”), is available within the Investor Relations section of Taro’s website at .taro.com. Buy Gallbladder online Hard copies of the report may be ordered free of charge by sending requests to Taro Pharmaceuticals U.S.A., Inc., Three Skyline Drive, Hawthorne, NY 10532, attention: William J. http://mdreview.wordpress.com Coote or via email to William.Coote@Taro.com. Additionally, the report may be accessed on the SEC’s website at .sec.gov. Taro Pharmaceutical Industries Ltd. Buy Lexapro (Escitalopram) without prescription is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products. About Lioresal (Baclofen) with free prescription For further information on Taro Pharmaceutical Industries Ltd., please visit Taro’s website at .taro.com.

Tuesday, July 8, 2014

EMD Serono Participates in Global Grants Program to Fund Scientific Innovation and Medical Education


ROCKLAND, Mass.--(BUSINESS WIRE)--EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, today announced its participation in the Merck Global Grants initiative – a program that underscores the company’s commitment to funding scientific innovation via research grants and supporting medical education of healthcare providers and patients around the world. The initiative encompasses all of the various grants that EMD Serono offers, including its Grants for Innovation in Research, its Independent Medical Grants, and Grants for Medical Education of Healthcare Providers and Patients. The global program totals an annual commitment of €20 million across all grants programs, highlighting the company’s collective efforts to promote advances in the field of medicine, address recognized gaps in healthcare knowledge, and improve the quality of patient care. “EMD Serono has a long-standing reputation as a strong advocate for scientific innovation and medical education, believing that both are integral to helping healthcare professionals deliver high-quality, innovative healthcare to patients,” said Steven Hildemann, Global Chief Medical Officer and Head of Global Medical and Safety at the biopharmaceutical division of Merck KGaA, Darmstadt, Germany. EMD Serono’s research grants program supports investigator-initiated clinical and pre-clinical research in various therapeutic areas. Its Innovation Grants focus on areas in which EMD Serono has a strong R&D presence, such as the Grant for Oncology Innovation, the Grant for Multiple Sclerosis Innovation, and the Grant for Fertility Innovation. For information about EMD Serono’s Innovation Grants, visit the following: 2.grantforoncologyinnovation.org/EMDSerono/index.html 2.grantformultiplesclerosisinnovation.org/EMDSerono/index.html 2.grantforfertilityinnovation.com/EMDSerono/index.html EMD Serono’s medical education grants program supports accredited educational activities for healthcare providers that improve patient care and provide valuable information to the medical community. Buy Diprolene (Betamethasone) with free prescription The program also supports fellowships and patient education initiatives. About Dostinex (Cabergoline) without Rx All grants are processed through an online web portal which allows highly transparent interactions with applicants. Dilantin (Phenytoin) without Rx For more information on EMD Serono’s medical education grants, please visit .grants.emdserono.com. For more information on independent medical grants available in the United States, please visit .img-emdserono.com. About EMD Serono, Inc. EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a specialized biopharmaceutical company dedicated to developing therapies with groundbreaking potential. About Beclate with free Rx The company has strong market positions in neurology, endocrinology and in reproductive health. Buy DL-Phenylalanine online In addition, EMD Serono has an enduring commitment to solve the unsolvable, with state-of-the-art science dedicated to developing new therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology. http://medicalquestionanswers.wordpress.com With a long-standing history of industry expertise and a dedication to shape the future of healthcare, the company’s US footprint continues to grow, with approximately 1,000 employees around the country and fully integrated commercial, clinical and research operations in the company’s home state of Massachusetts. For more information, please visit .emdserono.com. About Merck KGaA, Darmstadt, Germany Merck KGaA of Darmstadt, Germany, is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. Its subsidiaries in Canada and the United States operate under the umbrella brand EMD. Around 38,000 employees work in 66 countries to improve the quality of life for patients, to further the success of customers and to help meet global challenges. The company generated total revenues of €11.1 billion in 2013 with its four divisions: Biopharmaceuticals, Consumer Health, Performance Materials and Life Science Tools. Merck KGaA of Darmstadt, Germany is the world’s oldest pharmaceutical and chemical company – since 1668, the name has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day.

CliniWorks Forms a Strategic Alliance with Pfizer to Develop a Population Health Management Platform with Advanced Analytics and Patient Care Capabilities


CAMBRIDGE, Mass. & RAMAT HASHARON, Israel--(BUSINESS WIRE)--CliniWorks today announced a strategic alliance between its I subsidiary CliniWorks (Israel) Ltd. (“CliniWorks Israel”) and Pfizer Inc. (“Pfizer”) to jointly advance the parties’ respective capabilities in working with healthcare provider organizations to identify and close clinical or quality gaps to improve population health. The two companies are partnering to develop a population health management platform solution that leverages CliniWorks’ technologies in disparate data aggregation and Natural Language Processing (which interprets free text information) of de-identified healthcare data and Pfizer’s scientific, clinical and disease expertise. This platform will aim to enable large medical groups and integrated delivery system institutions to deliver near real-time and more efficient and effective quality healthcare, as well as improve patient engagement or activation, reaching the Centers for Medicare and Medicaid (CMS) Triple Aim. The development work will be partially supported by a grant received by CliniWorks and Pfizer from the BIRD Foundation (.birdf.com). Nitzan Sneh, CliniWorks CEO, said, “Pfizer’s leadership position in global healthcare and patient care complements our technology capabilities and, collectively, will bring about significant efficiencies for healthcare delivery organizations involved in the continuum of patient care.” “This alliance builds on our existing relationship with CliniWorks and will allow us to collaborate with our key customers in innovative and impactful ways to potentially improve healthcare delivery and patient outcomes,” said Teresa Griesing, VP North America Medical Affairs, Pfizer Global Innovation Pharma Business Unit. About CliniWorks, Israel and CliniWorks, Inc. CliniWorks (Israel) Ltd. is a wholly-owned subsidiary of CliniWorks, Inc. which is a global healthcare technology leader dedicated to the transformation of Big-data into actionable evidence-based decisions. CliniWorks, Inc. is privately held and based in Cambridge, Massachusetts. Its core technology has been vetted in the healthcare industry for 17 years and its leadership team has deep expertise in clinical data management. The company is dedicated to the simple, fast, and effective use of real-world evidence to accelerate clinical research, outcomes research, and improve healthcare performance, quality of care, patient-safety, compliance and adherence to meaningful use. Through the award winning Accel™ platform, CliniWorks provides actionable reports to identify gaps in clinical care across disease areas and provides a flexible user-interface to enable cohort identification for clinical trials. This technology platform has been deployed and maintained within multiple large healthcare systems nationwide and globally. Using real-world evidence, derived from millions of medical sources, CliniWorks provides healthcare organizations with tools to improve organizational performance expedite patient enrollment in clinical trials and drive research funding. For more information, visit us at .cliniworks.com. About Pfizer At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at .pfizer.com.

Monday, July 7, 2014

The Medicines Company ontvangt verlenging van markttoelating voor AngioxВ® (bivalirudine) van het Europees Geneesmiddelenbureau en de Europese Commissie

The Medicines Company ontvangt verlenging van markttoelating voor AngioxВ® (bivalirudine) van het Europees Geneesmiddelenbureau en de Europese Commissie


PARSIPPANY, N.J.--(BUSINESS WIRE)--The Medicines Company (NASDAQ: MDCO) heeft vandaag aangekondigd dat het Europees Geneesmiddelenbureau (EMA), het Comité voor geneesmiddelen voor menselijk gebruik (CHMP) en de Europese Commissie de verlenging van de markttoelating voor Angiox® (bivalirudine) hebben verleend na een evaluatie van de nieuwste klinische, veiligheids- en werkzaamheidsgegevens, evenals het risicobeheersplan voor Angiox. De aanbeveling van het CHMP voor de vernieuwing van de handelsvergunning voor Angiox bevestigt het gunstige risico-voordeel profiel ervan. Angiox is een directe trombineremmer en wordt in Europa voorgeschreven als antistollingsmiddel bij volwassen patiënten die een percutane coronaire interventie (PCI) ondergaan, waaronder patiënten met een myocardinfarct met ST-segmentstijging (STEMI) die een primaire PCI ondergaan. Angiox wordt in Europa ook voorgeschreven voor de behandeling van volwassen patiënten met instabiele angina - myocardinfarct zonder ST-segmentstijging (UA/NSTEMI) gepland voor dringende of vervroegde interventie. De verlenging geldt voor Angiox in alle lidstaten van de Europese Unie/Europese Economische Ruimte. Angiox heeft een gunstige klasse 1B aanbeveling voor gebruik bij STEMI- en NSTEMI-patiënten die een primaire PCI ondergaan in de richtlijnen van de European Society of Cardiology, die de basis vormen voor klinische besluitvorming. In meer dan 20 jaar klinische studie is aangetoond dat bivalirudine leidt tot een vergelijkbare werkzaamheid en minder bloedingen in vergelijking met heparine met of zonder gebruik van glycoproteïne IIb/IIIa-remmer (GPI) bij patiënten die een PCI ondergaan. Clomid (Clomiphene) with free Rx Bivalirudine is onderzocht in dertien multi-center klinische studies en een enkel centrum gerandomiseerde klinische studie bij meer dan 35.000 patiënten, en deze ondersteunen het gebruik van bivalirudine in geval van een PCI, ongeacht de femorale of radiale toegang en het type P2Y12-remmer. Buy Clozaril (Clozapine) with no prescription Voor STEMI-patiënten is aangetoond dat bivalirudine het overlijden met tot drie jaar uitstelt, onafhankelijk van de bloedingsstatus. Clarinex (Desloratadine) with free Rx Bovendien hebben grote waarnemingsregisters uit de echte wereld gegevens verzameld van ongeveer 500.000 patiënten die deze bevindingen ook ondersteunen. ”De door de EMA en CHMP verstrekte verlenging onderstreept de klinische waarde en het belang van Angiox in de hedendaagse interventionele cardiologie,” aldus Simona Skerjanec, Pharm.D., Senior Vice President & Acute Cardiovascular Care Global Innovation Group Leader bij The Medicines Company. Buy Aurorix without Rx “Angiox blijft een kritische antitrombine-optie voor interventionele cardiologen wereldwijd die erop vertrouwen als onderdeel van hun therapeutisch arsenaal in het cathlab en de PCI-zorgomgeving. Buy Cranberry online Aangetoond is dat Angiox vergelijkbare ischemische resultaten heeft en minder bloedingscomplicaties veroorzaakt in vergelijking met standaardzorg, alsook een vermindering van de mortaliteit in de Horizons AMI-studie. http://medicalquestionanswers.wordpress.com De voordelen ervan zijn in overeenstemming met onze missie om levens te redden, lijden te verlichten en de economische aspecten van de gezondheidszorg wereldwijd te verbeteren.” Over Angiox/Angiomax In Europa wordt Angiox momenteel voorgeschreven als antistollingsmiddel voor volwassen patiënten die een PCI ondergaan, waaronder patiënten met STEMI die een primaire PCI ondergaan. Angiox wordt tevens voorgeschreven voor de behandeling van volwassen patiënten met instabiele angina - myocardinfarct zonder ST-segmentstijging (UA/NSTEMI) gepland voor dringende of vervroegde interventie. Raadpleeg de volledige voorschrijvingsinformatie beschikbaar op .angiox.com. In de Verenigde Staten wordt bivalirudine op de markt gebracht onder de handelsnaam Angiomax en voorgeschreven bij patiënten die een PCI ondergaan met voorlopig gebruik van GPI en bij patiënten met - of die daarop risico lopen - heparine-geïnduceerde trombocytopenie en trombosesyndroom (HIT/HITTS) die een PCI ondergaan. Bovendien wordt Angiomax ook voorgeschreven voor gebruik als antistollingsmiddel bij patiënten met instabiele angina (UA) die een percutane transluminale coronaire angioplastiek (PTCA) ondergaan. Angiomax is bedoeld voor gebruik met aspirine. Angiomax is niet goedgekeurd voor gebruik bij patiënten met acuut coronair syndroom (ACS) die geen PCI of PTCA ondergaan. In klinische studies die Angiomax en heparine met elkaar hebben vergeleken, was de meest voorkomende bijwerking voor Angiomax bloedingen (28%). Andere vaak voorkomende bijwerkingen waren hoofdpijn, trombocytopenie en koorts. Een onverklaarbare daling van de bloeddruk of hematocriet, of andere onverklaarbare symptomen, dienen te leiden tot serieuze overweging van een hemorragische gebeurtenis en beëindiging van de toediening van Angiomax. Angiomax moet met voorzichtigheid worden gebruikt bij patiënten met een ziektetoestand die geassocieerd wordt met een verhoogd risico op bloedingen. In gamma brachytherapie is een verhoogd risico op trombusvorming, met mogelijke fatale gevolgen, geassocieerd met het gebruik van Angiomax. Angiomax is gecontra-indiceerd bij patiënten met actieve ernstige bloedingen of overgevoeligheid voor Angiomax of de componenten daarvan. Raadpleeg de volledige voorschrijvingsinformatie voor Angiomax beschikbaar op .angiomax.com. Over The Medicines Company Het doel van The Medicines Company is om levens te redden, lijden te verlichten en een bijdragen te leveren aan de economische aspecten van de gezondheidszorg door zich te richten op 3000 toonaangevende acute zorg/intensive care ziekenhuizen wereldwijd. De visie van het bedrijf is om een ​​toonaangevende leverancier te zijn van oplossingen op drie gebieden: acute cardiovasculaire zorg, chirurgie en peri-operatieve zorg, en zorg voor ernstige infectieziekten. Het bedrijf is actief in Noord- en Zuid-Amerika, Europa, het Midden-Oosten en regio s in Azië-Pacific. Momenteel beschikt het bedrijf over wereldwijde centra in Parsippany, NJ, VS, en Zürich, Zwitserland. Verklaringen in dit persbericht over The Medicines Company die niet van puur historische aard zijn, evenals alle andere die niet van puur historische aard zijn, kunnen gezien worden als toekomstgerichte verklaringen krachtens de safe harbor-bepalingen van de Private Securities Litigation Reform Act van 1995. Zonder beperking op het bovenstaande, worden woorden als gelooft , verwacht en vermoedt en vergelijkbare termen gebruikt om toekomstgerichte verklaringen aan te duiden. Deze toekomstgerichte verklaringen bevatten bekende en onbekende risico´s en onzekerheden waardoor werkelijke resultaten, omvang van activiteiten, prestaties of verwezenlijkingen aanzienlijk kunnen afwijken van die uitdrukkelijk vermeld of geïmpliceerd in deze toekomstgerichte verklaringen. Belangrijke factoren die deze verschillen kunnen veroorzaken of eraan kunnen bijdragen, zijn het feit of artsen, patiënten en andere belangrijke besluitvormers de resultaten van klinische proeven en andere factoren accepteren zoals uiteengezet in de risicofactoren die van tijd tot tijd staan beschreven in de periodieke verslagen van het bedrijf en de registratieverklaringen gedeponeerd bij de Securities and Exchange Commission, waaronder, zonder beperking, de risicofactoren beschreven in het kwartaalverslag van het bedrijf op Form 10-Q, ingediend bij de SEC op 12 mei 2014, die hierin door verwijzing zijn opgenomen. Het bedrijf ziet specifiek af van elke verplichting om deze toekomstgerichte verklaringen te actualiseren. Opmerking: dit persbericht werd uitgegeven in de Verenigde Staten en is bedoeld als referentiemateriaal voor Amerikaanse investeerders en journalisten. Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, welke als enige rechtsgeldig is.

La Jolla Pharmaceutical Company Strengthens Board of Directors with Appointment of Robert H. Rosen

La Jolla Pharmaceutical Company Strengthens Board of Directors with Appointment of Robert H. Rosen


SAN DIEGO, Calif.--(BUSINESS WIRE)--La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the “Company” or “La Jolla”), a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today announced the appointment of Robert H. Rosen to the Company’s Board of Directors. “We are honored to have Rob, who has a wealth of successful drug development and commercialization experience, join the board of directors of La Jolla Pharmaceutical Company,” said George Tidmarsh, Chief Executive Officer of La Jolla Pharmaceutical Company. “This will be especially important as we prepare to accelerate our drug development efforts.” Robert H. Rosen is currently President and a Director of Heron Therapeutics, a Nasdaq-listed specialty pharmaceutical company developing products using its Biochonomer polymer-based drug delivery platform. Clomid (Clomiphene) with free Rx He joined the company in October 2012 as Sr. Buy Clozaril (Clozapine) with no prescription Vice President and Chief Commercial Officer. Clarinex (Desloratadine) with free Rx Prior to Heron, Mr. Buy Aurorix without Rx Rosen was Managing Partner of Scotia Nordic LLC. Buy Cranberry online From April 2011 to March 2012, Mr. http://medicalquestionanswers.wordpress.com Rosen served as Senior Vice President of Global Commercial Operations at Dendreon Corporation, a biotechnology company. Prior to Dendreon, he served as global head of oncology at Bayer HealthCare, where he was responsible for the development of the global oncology business unit for regions that included the Americas, Europe, Japan, and Asia Pacific from 2005 to 2011. During his tenure at Bayer Healthcare, he led the launch of Nexavar for the treatment of renal cell carcinoma and hepatocellular carcinoma. Nexavar’s worldwide sales in 2011 were $1.0 billion. He also led premarket activities for Stivarga for gastrointestinal stromal tumors and colon cancer and alpharadin for prostate cancer. From 2002 to 2005, Mr. Rosen was vice president of the oncology business unit at Sanofi-Synthèlabo, where he was responsible for the development of Sanofi’s U.S. oncology business and the launch of Eloxatin for colon cancer. Eloxatin U.S. sales in 2005, its third full year on the market, were $1.1 billion, ranking it among the industry’s most successful oncology drug launches. Mr. Rosen received a Bachelor of Science degree in Pharmacy from Northeastern University. About La Jolla Pharmaceutical Company La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics for chronic organ failure and cancer. GCS-100, the Company s lead product candidate, is a first-in-class inhibitor of galectin-3, a novel molecular target implicated in chronic organ failure and cancer. GCS-100 currently is in Phase 2 clinical development for chronic kidney disease (CKD). LJPC-501, the Company’s second product candidate, is a natural peptide for the potential treatment of hepatorenal syndrome. LJPC-401, the Company’s third product candidate, is a natural peptide for the potential treatment of iron overload. For more information on the Company, please visit .ljpc.com.

Saturday, July 5, 2014

Woolworths backpedals


. http://medicalquestionanswers.wordpress.com Buy Bitter Melon online About Albuterol without prescription Cialis (Tadalafil) without prescription Buy Cialis Super Active (Tadalafil) with free Rx About Cialis Soft (Tadalafil) WHAT looks like a fumbled series of embarrassing decisions, Woolworths now appears to have backed down on its intention to employ pharmacy students and вЂ˜graduating pharmacists’ to conduct unsupervised in-store health checks. The move had been soundly criticised by the Pharmacy Guild, PSA and the Australian Medical Association, with the health move undertaken alongside top-selling supermarket lines such as cigarettes and alcohol. However Woolworths now says it will focus on employing nurses - despite the original advertisement on seek.com, placed by the firm XPO Brands which works for ...

Friday, July 4, 2014

Research and Markets Gardasil (Prophylactic Human PapillomaVirus Vaccines) - Forecast and Market Analysis to 2022


. About Aventyl (Nortriptyline) DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/qv8c85/gardasil) has announced the addition of the "Gardasil (Prophylactic Human PapillomaVirus Vaccines) - Forecast and Market Analysis to 2022" report to their offering. The first prophylactic vaccine for immunization against human papillomavirus (HPV) became available in 2006. Actonel with free Rx The global HPV vaccines market is now well established, yet vaccine coverage rates amongst the traditional target population of adolescent girls remain persistently low. Buy Arginine online Initially HPV vaccines were developed and marketed solely to protect against cervical cancer. http://medicalquestionanswers.wordpress.com In recent years the role of HPV in other cancers has been increasingly recognized which has facilitated a shift towards vaccinating a wider population, most significant has been the inclusion of males in routine vaccine recommendations in some countries. Buy Aventyl (Nortriptyline) with free Rx The current HPV vaccines market is dominated by one major player, Merck s Gardasil, with GlaxoSmithKline s (GSK s) HPV vaccine Cervarix providing the only competition. Buy Avodart (Dutasteride) with no prescription The introduction of Merck s nine-valent vaccine (V503) is set to change the future landscape of the HPV vaccines sector. Scope Overview of HPV, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape. Detailed information on Gardasil including product description, safety and efficacy profiles as well as a SWOT analysis. Sales forecast for Gardasil for the top nine countries from 2012 to 2022. Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan, Canada and Australia Reasons to buy Understand and capitalize by identifying products that are most likely to ensure a robust return Stay ahead of the competition by understanding the changing competitive landscape for HPV Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential Make more informed business decisions from insightful and in-depth analysis of Gardasil performance Key Topics Covered: 1 Table of Contents 2 Introduction 3 Disease Overview 4 Vaccination Recommendations and Coverage Rates 5 Competitive Assessment 6 Gardasil 7 Appendix For more information visit .researchandmarkets.com/research/qv8c85/gardasil

Wednesday, July 2, 2014

Quintiles conclui aquisição da Encore Health Resources


RESEARCH TRIANGLE PARK, Carolina do Norte, EUA--(BUSINESS WIRE)--A Quintiles anunciou hoje que concluiu a aquisição da Encore Health Resources (Encore), líder no setor de serviços de consultoria em tecnologia e análise de informações de saúde dedicada aos prestadores de assistência médica. "Estamos extremamente contentes em ter concluído a aquisição da Encore", declarou Scott Evangelista, presidente de Soluções e serviços comerciais integrados da Quintiles. "A inclusão da Encore aprimora grandemente nosso conhecimento específico em registros eletrônicos de saúde - uma área que continua a crescer em importância à medida que pagadores, prestadores e clientes biofarmacêuticos aumentam seu foco em evidências do mundo real. Estamos empolgados por podermos trabalhar junto com a equipe Encore e alavancar o conhecimento específico que cada organização possui para ajudar nossos clientes a melhorar sua probabilidade de sucesso." Agora conhecida como "Encore, A Quintiles Company (Encore, uma empresa Quintiles)", a Encore vai operar como parte do segmento de serviços integrados da área de saúde da Quintiles. Sobre a Quintiles A Quintiles (NYSE: Q), uma empresa listada no ranking Fortune 500, é a maior fornecedora mundial de serviços de desenvolvimento biofarmacêutico e terceirização comercial. Com uma rede de mais de 29 mil profissionais que realizam negócios em aproximadamente 100 países, ajudamos a desenvolver e comercializar todos os 100 medicamentos mais vendidos do mercado em 2013. About Actonel (Residronate) with no prescription Na Quintiles, aplicamos a amplitude e a profundidade de nossas ofertas de serviço juntamente com um extenso conhecimento especializado terapêutico, científico e analítico, ajudando os nossos clientes a atuar no ambiente cada vez mais complexo de assistência à saúde, enquanto buscam aumentar a eficiência e a eficácia no fornecimento dos melhores resultados de assistência à saúde. Buy Adalat (Nifedipine) without prescription Para saber mais sobre a Quintiles, acesse .quintiles.com. Declarações prospectivas Este comunicado à imprensa contém certas declarações identificadas como "declarações prospectivas", com o significado atribuído ao termo na Seção 27A da Securities Act de 1933 e na Seção 21E da Securities Exchange Act de 1934. Adalat (Nifedipine) with no Rx Essas declarações prospectivas refletem, entre outras coisas, expectativas atuais e os resultados esperados das operações da Quintiles, os quais estão sujeitos a riscos conhecidos e desconhecidos, incertezas e outros fatores que podem fazer com que os resultados reais, desempenho ou realizações da Quintiles, as tendências de mercado ou os resultados da indústria sejam materialmente diferentes daqueles expressos ou implícitos por essas declarações prospectivas. Buy A-Ret without prescription Portanto, quaisquer declarações contidas neste documento que não sejam declarações de fatos históricos podem ser declarações prospectivas e devem ser avaliadas como tal. Buy Adrenal Insufficiency online Sem limitar o precedente, as palavras “antecipa”, “acredita”, “estima”, “espera”, “pretende”, “pode”, “planeja”, “projeta”, “deve”, “orientação“, "objetiva”, "irá" e os antônimos dos mesmos e as palavras e expressões similares têm por objetivo identificar declarações prospectivas. http://futurepharmaceuticals.wordpress.com Estas declarações estão sujeitas a riscos, incertezas e suposições, incluindo a nossa capacidade de competir, integrar e alcançar nossos objetivos pretendidos no que diz respeito à aquisição proposta da Encore e aos descritos na seção intitulada “Fatores de Risco” do relatório anual da Quintiles no Formulário 10-K para o ano fiscal terminado em 31 de dezembro de 2013, protocolado junto à SEC em 13 de fevereiro de 2014, pois tais fatores podem ser corrigidos ou atualizados de tempos em tempos nos arquivamentos periódicos da Quintiles junto à SEC e acessíveis no site da SEC em .sec.gov. Esses fatores não devem ser considerados como completos e devem ser lidos em conjunto com as outras declarações de precaução que estão incluídas nesta versão e nos registros da Quintiles com a SEC. Exceto se exigido por lei, a Quintiles não assume a obrigação de atualizar quaisquer declarações prospectivas após a data deste comunicado, seja como resultado de novas informações, desenvolvimentos futuros ou qualquer outro motivo. Clique aqui para receber os alertas da Quintiles pelo celular. O texto no idioma original deste anúncio é a versão oficial autorizada. As traduções são fornecidas apenas como uma facilidade e devem se referir ao texto no idioma original, que é a única versão do texto que tem efeito legal.