Tuesday, September 16, 2014

Virology Publishes Genocea HSV-2 Antigen Discovery Paper


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genocea Biosciences, Inc. (NASDAQ: GNCA), a clinical-stage biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced that the peer-reviewed journal Virology has published a paper describing how Genocea used it’s ATLAS™ platform to identify the herpes simplex virus 2 (HSV-2) antigens for its GEN-003 clinical program. The paper, titled “Identification of novel virus-specific antigens by CD4+ and CD8+ T cells from asymptomatic HSV-2 seropositive and seronegative donors,” positively identified multiple viral antigens that are associated with naturally-induced protective CD4+ and CD8+ T cell responses, presenting possible targets for the development of new immunotherapies and prophylactic vaccines. Researchers from Genocea used the company’s proprietary proteomic screening technology, ATLAS™, to characterize T cell responses to specific antigens in infected (n=92) and virus-exposed seronegative subjects (n=52). Buy Diprolene (Betamethasone) with free prescription Findings confirmed for the first time that the specificity of T cell responses differ in symptomatic and asymptomatic patient cohorts. About Dostinex (Cabergoline) without Rx The data also suggest the frequency, breadth, and magnitude of peripheral CD8+, but not CD4+ T cell responses are associated with control of disease in HSV-2 infected subjects. Further, study authors found that uninfected subjects exposed to HSV-2 generate high frequency T cell responses against a more limited set of HSV-2 antigens. Dilantin (Phenytoin) without Rx Taken together, these findings suggest that rather than the breadth of response that is associated with the control of symptoms in already-infected subjects, it is the specificity of CD8+ T cell responses that is likely to play an important role in preventing HSV-2 infection. About GEN-003 GEN-003 is Genocea s lead product candidate and is a T cell-enabled immunotherapy intended to reduce the transmission risk and clinical symptoms of HSV-2. Desogestrel with free Rx In a Phase 1/2a study, patients showed statistically significant reductions in viral shedding and genital lesion rates of up to 52 percent and 65 percent respectively, with a durability of effect to six months after dosing in the 30µg dose group. Buy Soy Protein online A Phase 2 dose optimization study is currently ongoing. http://pharmaceuticaljournal.wordpress.com GEN-003 was designed with insights from Genocea s ATLAS™ platform. ATLAS™ profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to disease, enabling the identification of antigen targets which drive protective T cell responses with which to design potential new vaccines and immunotherapies. For more information about GEN-003, please visit .genocea.com/platform-pipeline/pipeline/gen003-for-hsv-2/. About HSV-2 Herpes simplex virus type 2 (HSV-2), the most common cause of genital herpes, is a sexually transmitted virus that is estimated to infect more than 500 million people worldwide. In the United States roughly 15 percent of the adult population, or 40 million people, are infected. HSV-2 infection can cause recurring, painful genital sores, and can be stigmatizing and produce considerable psychological distress in patients. The disease is particularly severe in immunosuppressed patients and poses significant risk to newborns if it is transmitted from mothers during birth. While antiviral drugs are used widely to treat HSV-2, there is neither a cure nor a vaccine for this disease. About Genocea Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immune response. Using ATLAS™, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea’s pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003 for HSV-2 therapy, GEN-004 to prevent infections caused by pneumococcus, and earlier-stage programs in chlamydia, HSV-2 prophylaxis, malaria and cancer immunotherapy. For more information, please visit the company’s website at .genocea.com. Forward Looking Statements Statements herein relating to future business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical developments, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including Genocea’s ability to progress any product candidates in preclinical or clinical trials; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; clinical trial results; current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, the product may not prove to be safe and efficacious; Genocea’s ability to enter into future collaborations with industry partners and the government and the terms, timing and success of any such collaboration; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; our ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; our ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; the availability of qualified personnel and other factors set forth under “Risk Factors” in Genocea’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013 and other filings with the Securities and Exchange Commission (the “SEC”). Further information on the factors and risks that could affect Genocea’s business, financial conditions and results of operations is contained in Genocea’s filings with the SEC, which are available at .sec.gov. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements.

Monday, August 4, 2014

NanoViricides to Restart its Anti-Ebola Virus Drug Development Program


WEST HAVEN, Conn.--(BUSINESS WIRE)--NanoViricides, Inc. (NYSE MKT:NNVC) (the “Company”) reports that it is restarting its drug development program to combat Ebola virus infections. The recent Ebola outbreak in West Africa has been the deadliest so far, per the World Health Organization (WHO). Ebola virus causes a deadly disease, with 60% to 90% of infected people dying, depending upon the strain of the virus. Clomid (Clomiphene) with free Rx Fortunately, it is transmitted only through close contact with an infected person’s body fluids, and not through aerosol or the water route, thus limiting its transmission. Currently, there are no licensed drugs or vaccines for Ebola, although some vaccines as well as some drug candidates have entered clinical trials. Ebola virus infects a wide variety of human cell types, by using various attachment receptors to enter endosome structures inside cells. Buy Clozaril (Clozapine) with no prescription Upon entry, the virus binds to its cognate receptor, the Niemann-Pick C1 cholesterol transporter protein inside the late endosomes, fuses with the endosomal membrane, and thus enters the cytoplasm. Clarinex (Desloratadine) with free Rx It replicates, buds out of the cell, and the cycle repeats itself. Buy Defenac The virus shuts down several of the host’s immune system defenses, and thus gains an upper hand. “We believe that with our ‘intelligent nanomachines’ approach we have the potential to develop superior therapeutics as compared to other approaches,” said Anil R. Buy Scalp Treatments online Diwan, PhD, President of the Company. “We are happy to restart the Ebola program, considering the public health impact of the Ebola virus infection,” said Dr. http://pharmaceuticaljournal.wordpress.com Eugene Seymour, MD, MPH, CEO of the Company, adding, “We are in a strong financial position now, enabling us to work on this project while we continue to advance our FluCide™ and DengueCide™ therapies further towards clinical trials. We hope to create highly effective drugs against Ebola, similar to what we have achieved with our FluCide™ Influenza drug candidate.” The Company’s first drug candidate, NV-INF-1, Injectable FluCide™, is designed to treat all influenza infections in hospitalized patients. Influenza A H1N1 infected animals treated with FluCide survived the full 21-day observation period, whereas animals treated with 40mg/kg/d oseltamivir phosphate (Tamiflu®) survived only 8 days in this highly lethal study. NV-INF-1 demonstrated an unparalleled 1,000-fold reduction in lung viral load compared to untreated animals on day 4 in this lethal animal model study. Moreover, the lung viral load remained suppressed to this baseline level. In contrast, the current standard of care, oseltamivir, (Tamiflu®, Roche) exhibited only a 2-fold reduction in lung viral load at day 4, that rapidly rose by approximately 2X on day 7. NV-INF-1 also caused the lungs of treated animals to remain substantially healthier than the untreated control or oseltamivir-treated mice. Further, NV-INF-1 has been found to be extremely safe in preliminary safety/toxicology studies. The Company currently has approximately $41 million cash-in-hand and cash-like-instruments. These funds are estimated to be sufficient for taking at least one of our drug candidates through initial human clinical trials, and possibly take another drug candidate into human clinical trials. NanoViricides, Inc. now has its own drug manufacturing facility that is capable of producing sufficient quantities of an anti-Ebola drug after it is developed, for combating Ebola epidemics. Approximately 729 people have died and 1300 infected from Ebola virus in the current epidemic. Two US health care workers, a doctor and a nurse, also contracted ebola infection. The doctor’s health appears to be improving, at Emory University Hospital, said a recent news report. There is practically no public health risk from known cases such as these because of the extremely strong precautions that are taken in handling them. However, it takes anywhere from 2 to 20 days for ebola virus illness signs to appear after infection. In addition, the virus may persist up to 7 weeks in bodily fluids of recovered patients. Therefore, it is possible that transmission could sometimes occur far away with air travel, unknowingly. (Sources: .cdc.gov/vhf/ebola/ , “Why Ebola is So Dangerous” - .bbc.com/news/world-africa-26835233 , “Ebola Virus Disease”- .who.int/mediacentre/factsheets/fs103/en/). About NanoViricides: NanoViricides, Inc. (.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for viral therapy. The Company s novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. This press release contains forward-looking statements that reflect the Company s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company s expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

Wednesday, July 23, 2014

Survey How Doctors Read and What it Means to Patients

Survey How Doctors Read and What it Means to Patients


SAN FRANCISCO--(BUSINESS WIRE)--Nearly 75 percent of physicians change their clinical practices quarterly or monthly based on reading medical literature, according to a Doximity survey conducted last week. The survey also found that 98 percent of physicians reported reading medical literature is important or very important to their practice. However, despite the perceived value of medical literature, it can be challenging for physicians to keep up on news. A report in the Journal of the American Medical Library Association (JAMLA) found that over 7,000 articles are published monthly in primary care journals alone. “Medicine has a TL;DR problem (Too Long; Didn’t Read),” said Nate Gross, MD, co-founder of Doximity. Buy Aldactone (Spironolactone) without Rx “It would take 20 hours of reading each day for the average physician to comb through everything published in their speciality. About Alesse (Levonorgestrel Bp + Ethinylestradiol Bp) with free prescription At Doximity, we address this issue by identifying the most important news for an individual member and delivering it straight to them - saving time and ensuring that life-saving clinical news is actually read.” Survey findings: 98 percent of physicians reported that reading medical literature was important or very important to their practice. 16 percent of physicians reported that reading medical literature directly helped save the life of a patient in the last year, with medical news of rare immune disorders, new melanoma treatments and stroke guidelines cited in physician stories. When asked how often reading medical literature directly changed their clinical practice with patients, 14 percent of physicians reported changing weekly, 28 percent reported monthly, 44 percent reported quarterly and 14 percent reported yearly. 44 percent of physicians reported spending 1 to 2 hours a week reading news online on a smartphone, computer or tablet. About Alesse (Levonorgestrel BP, Ethinylestradiol BP) with free Rx 22 percent read news online 3 to 4 hours a week and 24 percent read more than 5 hours a week online. Buy Cortef with no Rx Only 10 percent read news online less than an hour a week. Doximity currently has over 40 percent of US physicians as members of its professional network. Buy Osteoporosis online Doximity’s Curator algorithm is used to power DocNews, the first and only service to automatically source medical news based on a physician’s professional interests, publishing history and clinical expertise - an average of 28 profile data points per member. “Doximity s DocNews offered timely news and a common platform to inform our practice and stimulate conversation among our surgeons about the best approaches for atrial fibrillation treatment,” said Hassan Tetteh, MD, a Washington DC-based surgeon specializing in thoracic surgery, critical care, and heart and lung transplantation. http://pharmaceuticaljournal.wordpress.com “Having a secure dynamic platform like Doximity to share knowledge and communicate with my medical colleagues is priceless." Physicians interested in receiving for free personalized DocNews updates can learn more at .doximity.com/curate. Survey Methodology Doximity’s survey of physicians was conducted online between July 9 and July 17, 2014 with 80 responses. About Doximity Launched in 2011, Doximity (.doximity.com) connects physicians to make them more successful and productive. With more than 40 percent of U.S. physicians as members, collaborating across every specialty and academic medical center, Doximity is the largest secure medical network on the Internet. Doximity is headquartered in Silicon Valley and was created by the founders of Epocrates (NASDAQ:EPOC), now owned by athenahealth, Inc. (NASDAQ:ATHN).

Friday, July 18, 2014

Resumen GVK BIO lanza nueva "marca" para un renovado enfoque hacia el cliente en su oferta de servicios de desarrollo cl'inico


. http://pharmaceuticaljournal.wordpress.com Buy Hard On Oral Jelly (Sildenafil Citrate) MUMBAI, India--(BUSINESS WIRE)--GVK Biosciences (GVK BIO), la organizaci on de desarrollo e investigaci on de descubrimiento l ider en Asia, ha presentado hoy la nueva marca CLINOGENT en el sector del desarrollo cl inico. Buy Yasmin (Drospirenone, Ethinyl, Estradiol) with no prescription CLINOGENT ofrece servicios de desarrollo cl inico de principio a fin. Co-betaloc with no prescription CLINOGENT se compromete a ofrecer soluciones innovadoras para resolver todos los retos cient ificos y cl inicos a los que se enfrentan los clientes. El comunicado en el idioma original, es la versi on oficial y autorizada del mismo. Buy NAC online Hard On (Sildenafil Citrate) with no Rx La traducci on es solamente un medio de ayuda y deber a ser comparada con el texto en idioma original, que es la unica versi on del texto que tendr a validez legal.

Thursday, July 17, 2014

De nouvelles 'etudes pr'esent'ees lors de la conf'erence internationale de l’Alzheimer’s Association d'emontrent la valeur diagnostique du18F]Flutemetamol de GE Healthcare


COPENHAGUE, Danemark--(BUSINESS WIRE)--Les donn ees provenant d’une nouvelle etude pr esent ees aujourd’hui lors de la conf erence internationale de l’Alzheimer’s Association® 2014 (AAIC®) ont montr e qu’une imagerie TEP positive au [18F]flutemetamol pour le d epistage d’une plaque amylo"ide c er ebrale constituait un indicateur particuli`erement significatif de la progression de la pathologie - d’une atteinte cognitive amn esique l eg`ere (aMCI) `a une probable maladie d’Alzheimer (pAD).1 Une seconde etude a d emontr e la valeur diagnostique du [18F]flutemetamol en confirmant la pr esence d’une plaque amylo"ide neuritique chez les patients atteints de d emence pr ecoce. 2 [18F]Flutemetamol est le produit radiopharmaceutique candidat de GE Healthcare pour l’imagerie TEP de la densit e de la plaque de b^eta-amylo"ide neuritique dans le cerveau des patients adultes atteints de d eficience cognitive en cours d’ evaluation pour la maladie d’Alzheimer et d’autres causes de d eficience cognitive. « Collectivement, ces donn ees d emontrent la valeur diagnostique de [18F]flutemetamol et confortent le nombre croissant de preuves confirmant qu’il peut aider les m edecins `a identifier l’histopathologie associ ee `a un diagnostic de maladie d’Alzheimer dans une population sp ecifique de patients, » a affirm e Ger Brophy, PhD, directeur de la technologie, Sciences de la Vie, chez GE Healthcare. « S’il est approuv e dans l’Union europ eenne, [18F]flutemetamol constituera un outil important pour soutenir l’ evaluation des patients atteints de d eficiences cognitives, ainsi qu’un pr ecieux outil de recherche dans notre qu^ete de th erapies permettant de lutter contre la maladie d’Alzheimer. » Utilisation de l’imagerie TEP au [18F]Flutemetamol comme indicateur de la progression de la maladie - d’une atteinte cognitive amn esique l eg`ere `a une probable maladie d’Alzheimer Dans cette etude, 232 participants atteints de d eficience cognitive l eg`ere, un diagnostic caract eris e par des d eficiences cognitives insuffisantes pour avoir un effet sur le fonctionnement quotidien et ne correspondant par cons equent pas `a la d efinition de la d emence, ont recu une piq^ure de [18F]flutemetamol et subi une imagerie du cerveau. Buy Diprolene (Betamethasone) with free prescription L’ etude a montr e que les patients ayant obtenu un r esultat positif `a l’imagerie au VIZAMYL etaient environ 2,5 fois plus susceptibles de contracter une probable maladie d’Alzheimer (pAD) que ceux ayant obtenu un r esultat n egatif. About Dostinex (Cabergoline) without Rx La capacit e qu’a l’imagerie TEP positive au [18F]flutemetamol d’identifier les patients souffrant d’une atteinte cognitive amn esique l eg`ere de avec un risque elev e de progression de la maladie jusqu’au stade de maladie d’Alzheimer pourrait permettre de mieux evaluer et g erer les patients, tout en soutenant leur stratification pour un recrutement dans des essais cliniques portant sur des m edicaments modificateurs de la maladie. « Ces conclusions d emontrent le r^ole potentiel du [18F]flutemetamol dans la stratification des patients qui pr esentent un risque elev e de d evelopper la maladie d’Alzheimer, outre son utilisation comme outil de diagnostic, » a d eclar e David Wolk, MD, directeur-adjoint du Penn Memory Center et investigateur principal dans le cadre de cette etude. Dilantin (Phenytoin) without Rx « Outre le fait de fournir aux patients des informations pronostiques potentiellement importantes au sujet de leur probabilit e de d evelopper une d emence, le fait d’identifier les patients `a haut risque pourrait aider `a orienter les recommandations des m edecins en termes de surveillance des patients, de r egimes de soins de sant e et d’utilisation des ressources diagnostiques. Desogestrel with free Rx Il s’agit l`a de r esultats passionnants, mais nous devons poursuivre nos recherches afin de comprendre enti`erement comment ceux-ci peuvent ^etre utilis es dans la pratique clinique. » Valeur diagnostique du [18F]Flutemetamol) dans la d emence pr ecoce Dans cette etude, 80 patients atteints de d emence pr ecoce (^ag es de moins de 70 ans) et pr esentant une fiabilit e diagnostique m edicale inf erieure `a 90 % ont subi des imageries TEP au [18F]flutemetamol, evalu ees comme etant amylo"ide positives ou n egatives. Buy Soy Protein online Le diagnostic clinique et la fiabilit e diagnostique ont et e etudi es, `a la fois avant et apr`es communication des r esultats de l’imagerie. http://pharmaceuticaljournal.wordpress.com Cette etude a d emontr e que l’utilisation du [18F]flutemetamol aidait les m edecins `a accro^itre la fiabilit e diagnostique et, chez de nombreux patients, `a confirmer ou exclure le diagnostic de maladie d’Alzheimer, ce qui permettait d’adapter en cons equence la gestion de la maladie. « Des diagnostics pr ecoces et pr ecis pourraient avoir des cons equences `a la fois en termes de pronostic et de traitement des patients atteints de d emence pr ecoce, » a affirm e le Dr. Marissa Zwan du VU University Medical Center d’Amsterdam, principale investigatrice de cette etude. « Une plus grande fiabilit e diagnostique permet de soutenir une meilleure gestion du patient et aide les m edecins `a d eterminer les options de traitements ad equates, tout en aidant les patients et les soignants `a etablir des plans pour l’avenir. » Les donn ees ont montr e que le diagnostic etait modifi e pour 20 % des patients suite `a l’analyse de l’imagerie au [18F]flutemetamol. Plus particuli`erement, le diagnostic clinique de 12 patients sur 15 diagnostiqu es comme atteints de la maladie d’Alzheimer avant l’imagerie au [18F]flutemetamol qui pr esentaient un r esultat n egatif amylo"ide a et e modifi e. Dans l’ensemble, la fiabilit e diagnostique s’est accrue de mani`ere significative, passant de 67 %(±12) `a 90 %(±16) apr`es communication des r esultats de l’imagerie. En outre, chez 48 % des patients, les r esultats de l’imagerie TEP au 18F]flutemetamol ont abouti `a un changement en termes de gestion des soins de sant e du patient (c’est `a dire, des changements de r egimes m edicamenteux, des soins additionnels). En octobre 2013, [18F]flutemetamol a recu l’approbation de la Food and Drug Administration am ericaine. Il est commercialis e sous l’appellation VIZAMYL™ aux Etats-Unis, pour l’imagerie m edicale (tomographie par emission de positrons – PET) du cerveau destin ee `a l’ evaluation de la densit e de la plaque b^eta-amylo"ide neuritique chez les patients adultes atteints de d eficience cognitive en cours d’ evaluation pour la maladie d’Alzheimer ou d’autres causes de d eficience cognitive. Uniquement destin e `a une utilisation diagnostique, VIZAMYL doit ^etre utilis e parall`element `a une evaluation clinique. VIZAMYL n’est homologu e sur aucun march e pour l’ evaluation du risque de progression de la maladie - de la d eficience cognitive l eg`ere `a la maladie d’Alzheimer. En juin 2014, [18F]flutemetamol a recu un avis positif du Comit e des M edicaments `a usage humain (CHMP) de l’Agence Europ eenne des M edicaments, qui a recommand e l’octroi d’une autorisation de commercialisation de l’imagerie TEP pour l’ evaluation de la densit e de la plaque b^eta-amylo"ide neuritique dans le cerveau des patients adultes atteints de d eficience cognitive en cours d’ evaluation pour la maladie d’Alzheimer et d’autres causes de d eficience cognitive. Le m edicament n’est pas encore approuv e pour une utilisation en Europe ou au Japon. L’ENGAGEMENT DE GE HEALTHCARE EN FAVEUR DE LA RECHERCHE EN IMAGERIE [18F]Flutemetamol est l’un des composants du vaste portefeuille de solutions diagnostiques exp erimentales en cours de d eveloppement par GE Healthcare dans le domaine de la neurologie. GE Healthcare adopte une approche exhaustive de la compr ehension de la d emence et de la maladie d’Alzheimer par le biais de sa recherche en cours qui vise `a d ecouvrir les causes, les risques et les effets physiques de la maladie. GE Healthcare offre un vaste portefeuille de ressources d’imagerie qui comprend des cyclotrons et des syst`emes chimiques de fabrication d’agents d’imagerie TEP, ainsi que des scanners TEP et MR pour les patients, et qui d eveloppe actuellement un logiciel d’analyse des images afin de fournir des outils de quantification, de visualisation optimis ee et de production de rapports. En outre, GE Healthcare collabore avec l’industrie pharmaceutique afin de participer `a l’ elaboration de la prochaine g en eration de th erapies. Dans cette optique, nous travaillons avec des partenaires potentiels de l’industrie afin de comprendre leurs besoins strat egiques, et nous les aidons `a fournir un support d’imagerie dans le cadre de leurs essais cliniques portant sur des agents th erapeutiques. `A PROPOS DE GE HEALTHCARE GE Healthcare offre des technologies et services m edicaux transformatifs permettant de r epondre `a la demande d’acc`es accru, d’am elioration de la qualit e et de soins de sant e plus abordables dans le monde entier. GE (NYSE: GE) se consacre aux choses qui comptent vraiment - un personnel et des technologies sup erieurs, capables de relever des d efis de taille. De l’imagerie m edicale aux solutions d’am elioration de la performance, en passant par les logiciels et les technologies de l’information, la surveillance des patients et les diagnostics, la d ecouverte de m edicaments et les technologies de fabrication biopharmaceutiques, GE Healthcare aide les professionnels de la sant e `a fournir des soins de qualit e `a leurs patients. Pour nos toutes derni`eres actualit es, veuillez visiter 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. Data presented at Alzheimer’s Association International Conference® 2014 2 Zwan MD, Bouwman FH, Lammertsma AA, et al. Clinical Impact of [18F]Flutemetamol PET in Young Onset Dementia. Data presented at Alzheimer’s Association International Conference® 2014 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.

Monday, July 14, 2014

ARIAD Announces Continuation of Iclusig Review under the Article 20 Procedure in Europe


CAMBRIDGE, Mass. & LAUSANNE, Switzerland--(BUSINESS WIRE)--ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has provided the Company with a request for limited additional information regarding Iclusig® (ponatinib) as part of its ongoing review under the Article 20 referral procedure. Hard On (Sildenafil Citrate) with no Rx The PRAC has requested further information regarding proposed dose modifications after achievement of a response and patient monitoring and details concerning a risk management plan. Buy Hard On Oral Jelly (Sildenafil Citrate) Following ARIAD’s response and input from the agency’s Scientific Advisory Group, the Company expects that the PRAC will complete its review and make final recommendations to the Committee for Medicinal Products for Human Use (CHMP) at its meeting in October 2014. “As we finalize our recommendations on dose modifications of Iclusig and response monitoring of patients, we will work closely with the European regulatory agency and its expert advisors so that CML patients and their treating physicians have the best guidance available supporting the appropriate use of Iclusig,” said Timothy P. Buy Yasmin (Drospirenone, Ethinyl, Estradiol) with no prescription Clackson, Ph.D., president of research and development and chief scientific officer at ARIAD. In March 2014 ARIAD submitted responses to initial questions outlined by the PRAC as part of the Article 20 process, which was initiated in December of last year, and responses to a second set of questions were submitted to the PRAC in June. The authorized indications of Iclusig in Europe, as approved in July 2013, remain as follows: The treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or The treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. To view the Iclusig Summary of Medicinal Product Characteristics, click here. The PRAC is the committee at the EMA that is responsible for assessing and monitoring safety issues for human medicines. Co-betaloc with no prescription The PRAC s recommendations are considered by the CHMP when it adopts opinions for centrally authorized medicines and referral procedures. About CML and Ph+ ALL CML is a cancer of the white blood cells that is diagnosed in approximately 7,000 patients each year in Europe[1]. Buy NAC online CML is characterized by an excessive and unregulated production of white blood cells by the bone marrow due to a genetic abnormality that produces the BCR-ABL protein. http://pharmaceuticaljournal.wordpress.com After a chronic phase of production of too many white blood cells, CML typically evolves to the more aggressive phases referred to as accelerated phase and blast crisis. Ph+ ALL is a subtype of acute lymphoblastic leukaemia that carries the Ph+ chromosome that produces BCR-ABL. It has a more aggressive course than CML and is often treated with a combination of chemotherapy and tyrosine kinase inhibitors. The BCR-ABL protein is expressed in both of these diseases. About Iclusig® (ponatinib) Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. About ARIAD ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-to-treat cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit .ariad.com or follow ARIAD on Twitter (@ARIADPharm). This press release contains “forward-looking statements” including, but not limited to, updates on regulatory developments in Europe. Forward-looking statements are based on the Company’s expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, a potential decision by the CHMP not to adopt the recommendations of the PRAC or the European Commission not to adopt the recommendation of the CHMP, or, in either case, to adopt the recommendation but with revisions affecting the Company’s ability to successfully commercialize and generate profits from sales of Iclusig; difficulties in commercializing Iclusig arising from the post-marketing approval review process or from its results; the emergence of new safety concerns based on additional adverse events in patients being treated with Iclusig and other risk factors detailed in the Company s public filings with the U.S. Securities and Exchange Commission. The information contained in this press release is believed to be current as of the date of original issue. The Company does not intend to update any of the forward-looking statements after the date of this document to conform these statements to actual results or to changes in the Company s expectations, except as required by law. Iclusig® is a registered trademark of ARIAD Pharmaceuticals, Inc. Reference: 1. Rohrbacher M, Hasford J. Epidemiology of chronic myeloid leukaemia (CML). Best Pract Res Clin Haematol. 2009 Sept;22(3):295-302. Based on current estimate of population of Europe (738,199,000 in 2010).

Saturday, July 12, 2014

Le 25e Prix Plasticit'e Neuronale de la Fondation Ipsen a 'et'e attribu'e `a Barry J. Everitt (Cambridge, Royaume-Uni), George F. Koob (La Jolla, 'Etats-Unis) et Michel Le Moal (Bordeaux, France)


PARIS--(BUSINESS WIRE)--Le 25e Prix annuel Plasticit e Neuronale de la Fondation Ipsen a et e attribu e `a trois chercheurs pour leurs travaux pr ecurseurs dans le domaine de la "Neuropsychologie de la toxicomanie" : Barry J. Everitt (University of Cambridge, Cambridge, Royaume-Uni), George F. Koob (The Scripps Research Institute, La Jolla, Etats-Unis) et Michel Le Moal (Inserm U862, Bordeaux, France). About Viagra (Sildenafil Citrate) with no Rx La bourse de 60 000 € a et e attribu ee le 8 juillet 2014 durant la FENS (Federation of European Neuroscience Societies) `a Milan, par un jury international pr esid e par le professeur Nikos Logothetis (Max Planck Institute for Biological Cybernetics, T"ubingen, Allemagne). Les laur eats Barry Everitt est professeur et directeur de recherche, et recteur du Gates Cambridge Trust, de l’University of Cambridge. About Viagra Soft (Sildenafil Citrate) Il est titulaire d un Master de zoologie obtenu en 1967 `a la Hull University, et d un Doctorat en neuroendocrinologie comportementale obtenu `a l’University of Birmingham Medical School en 1970. Trandate (Labetalol) without Rx Apr`es son doctorat, il a men e des recherches d eterminantes en neuroscience au Karolinska Institutet de Stockholm (1973-1974), et a et e nomm e charg e de cours, puis ma^itre de conf erences en neuroscience au d epartement d anatomie de l’University of Cambridge. About Clamycin Il a int egr e le D epartement de psychologie exp erimentale de Cambridge en 1995 et a et e nomm e Professeur de neuroscience comportementale. Buy Mangosteen online Il a et e elu Membre de la Royal Society en 2007, Membre de l’Academy of Medical Sciences en 2008, et Membre de l EMBO en 2014. Les recherches de Barry Everitt ont pour objectif la compr ehension des m ecanismes neuronaux de la motivation, de l apprentissage et de la m emoire, en particulier dans le contexte de la toxicomanie. http://pharmaceuticaljournal.wordpress.com Son laboratoire a fait des d ecouvertes fondamentales sur les syst`emes limbiques corticostriataux m ediant les m ecanismes pavloviens et instrumentaux d apprentissage et de m emoire, qui sont sous-jacents `a la recherche et `a la consommation de drogues addictives. Il s int eresse egalement de pr`es au fondement mol eculaire et syst emique de la reconsolidation des souvenirs de la drogue addictive et des souvenirs de peur, et `a la possibilit e de cibler les souvenirs m esadapt es dans le cadre du traitement des troubles neuropsychiatriques, notamment de l addiction. Il a et e pr esident de la British Association for Psychopharmacology (1992-1994), de la European Brain and Behaviour Society (1998-2000), et de la European Behavioural Pharmacology Society (2003-2005). Il a et e r edacteur-en-chef du European Journal of Neuroscience (1997-2008) et est actuellement r edacteur-r eviseur pour la revue Science. Il a recu de nombreux prix, notamment le Distinguished Scientific Contribution Award de la American Psychological Association (2011), le Distinguished Scientific Achievement Award de la European Behavioural Pharmacology Society (2011), et le FENS-EJN Award de la Federation of European Neuroscience Societies (2012). Dr George F. Koob a et e nomm e r ecemment directeur du National Institute on Alcohol Abuse and Alcoholism (National Institutes of Health, Washington DC). En tant que sp ecialiste de l alcoolisme, de la toxicomanie et du stress. Il est l’auteur d travaux qui ont permis de mieux comprendre les neurocircuits associ es aux effets renforcateurs aigus de l alcool et de la drogue, ainsi que les neuroadaptations des circuits des r ecompenses et du stress associ ees `a la transition vers la d ependance. Le Dr Koob a publi e plus de 600 articles `a comit e de lecture et plusieurs ouvrages, notamment Neurobiology of Addiction, un trait e complet sur les recherches emergentes sur le sujet. Michel Le Moal est Professeur em erite de Neuroscience `a l Universit e de Bordeaux. Dipl^om e en m edecine (1962), en philosophie et sociologie, en sciences naturelles, en neurologie (1967), ainsi qu en psychiatrie (1968). Il a obtenu un Doctorat en science `a l Universit e de Bordeaux en 1974. Parall`element `a son travail d enseignement `a Bordeaux, il a travaill e plusieurs ann ees comme chercheur associ e ou professeur `a Caltech (Pasadena), dans le laboratoire de Jim Olds (1974-1976), au Salk Institute et au Scripps Research Institute (San Diego), dans les laboratoires de Floyd Bloom et George Koob (1979-1994). Dans ces deux institutions, il a travaill e sur l electrophysiologie des neurones dopaminergiques, puis sur les r^oles jou es par les syst`emes CRF et dopaminergique dans le comportement et la toxicomanie. Ses recherches portent sur les processus comportementaux et adaptatifs, leurs fondements biologiques et la psychopathologie exp erimentale, discipline qu il a tent e de promouvoir. Le concept de vuln erabilit e individuelle aux pathologies comportementales est au centre de ses hypoth`eses de travail. Michel Le Moal a fond e et dirig e plusieurs laboratoires de recherche du CNRS et de l Inserm, avant de diriger l’Institut Magendie de Neuroscience et de Psychiatrie de Bordeaux. Il a et e elu membre de l Acad emie des Sciences. Le Prix Plasticit e Neuronale Cr e e en 1990, le Prix Plasticit e Neuronale de la Fondation Ipsen compte au nombre de ses r ecipiendaires des scientifiques majeurs : Albert Aguayo (Montr eal, 1990), Anders Bj"orklund (Lund, 1990), Fred Gage (La Jolla, 1990), Ursula Bellugi (La Jolla, 1991), Wolf Singer (Francfort, 1990), Torsten Wiesel (New York, 1991), Philippe Ascher (Paris, 1992), Kjell Fuxe (Stockholm, 1992), Terje Lomo (Oslo, 1992), Per Andersen (Oslo, 1993), Masao Ito (Wako Saitama, 1993), Constantino Sotelo (Paris, 1993), Mariano Barbacid (Princeton, 1994), Yves Barde (Planegg-Martinsried, 1994), Hans Thoenen (Planegg-Martinsried, 1994), Jacques Mehler (Paris, 1995), Brenda Milner (Montr eal, 1995), Mortimer Mishkin (Bethesda, 1995), Friedrich Bonhoeffer (Tubingen, 1996), Corey Goodman (Berkeley, 1996), Marc Tessier-Lavigne (San Francisco, 1996), Antonio Damasio (Iowa City, 1997), Richard Frackowiac (Londres, 1997), Michael Merzenich (San Francisco, 1997), Heinrich Betz (Francfort, 1998), Gerald Fischbach (Boston, 1998), Uel McMahan (Stanford, 1998), Masakazu Konishi (Pasadena, 1999), Peter Marler (Davis, 1999), Fernando Nottebohm (Millbrook, 1999), Tomas H"okfelt (Stockholm, 2000), Lars Olson (Stockholm, 2000), Lars Terenius (Stockholm, 2000), Albert Galaburda (Boston, 2001), John Morton (Londres, 2001), Elisabeth Spelke (Cambridge, USA, 2001), Arturo Alvarez-Buylla (San Francisco, 2002), Ronald Mc Kay (Bethesda, 2002), Sam Weiss (Calgary, 2002), Francois Clarac (Marseille, 2003), Sven Grillner (Stockholm, 2003), Serge Rossignol (Montr eal, 2003), James Gusella (Boston, 2004), Jean-Louis Mandel (Strasbourg, 2004), Huda Y. Zoghbi (Houston, 2004), Ann Graybiel (Cambridge, USA, 2005), Trevor Robbins (Cambridge, UK, 2005), Wolfram Schultz (Cambridge, UK, 2005, Eckhart D. Gundelfinger (Magdeburg, 2006), Mary B. Kennedy (Pasadena, 2006), Morgan Sheng (Cambridge, USA, 2006), Nikos K. Logothetis (T"ubingen, 2007), Keiji Tanaka (Wako, 2007), Giacomo Rizzolati (Parma, 2007), Jean-Pierre Changeux (Paris, 2008), Peter W. Kalivas (Charleston 2008), Eric J. Nestler (Dallas, 2008), Alim-Louis Benabid (Grenoble, 2009), Apostolos P. Georgopoulos (Minneapolis, 2009) , Miguel A. L. Nicolelis (Durham, 2009), Thomas Insel (Bethesda, 2010), Bruce Mc Ewen (New York, 2010) and Donald Pfaff (New York, 2010), Helen Neville (Eugene, 2011), Isabelle Peretz (Montr eal, 2011), Robert Zatorre (Montr eal, 2011), Catherine Dulac (Boston, 2012), Richard G. Morris (Edinburgh, 2012), J. David Sweatt (Birmingham, 2012), Tim V.P. Bliss (London, 2013), Richard G. M. Morris (Edinburgh, 2013), Yadin Dudai (Rehovot, 2013). Le jury : Albert Aguayo (Montr eal General Hospital, Montr eal, Canada), Jo"el Bockaert (Institut de G enomique Fonctionnelle, Montpellier, France), Alexis Brice (H^opital de la Salp`etri`ere, Paris, France), Stanislas Dehaene (Inserm U562, Orsay, France), Stephen Dunnett (Cardiff University, Cardiff, UK), Kjell Fuxe (Karolinska Institute, Stockholm, Sweden), Christine Petit (Institut Pasteur, Paris, France), Wolf Singer (Max-Planck Institute for Brain Research, Francfort, Allemagne). La Fondation Ipsen Cr e ee en 1983 sous l egide de la Fondation de France, la Fondation Ipsen a pour vocation de contribuer au d eveloppement et `a la diffusion des connaissances scientifiques. Inscrite dans la dur ee, l action de la Fondation Ipsen vise `a favoriser les interactions entre chercheurs et cliniciens, echanges indispensables en raison de l extr^eme sp ecialisation de ces professions. L ambition de la Fondation Ipsen est d initier une r eflexion sur les grands enjeux scientifiques des ann ees `a venir. La Fondation a d evelopp e un important r eseau international d experts scientifiques qu’elle r eunit r eguli`erement dans le cadre de Colloques M edecine et Recherche, consacr es `a cinq grands th`emes: la maladie d Alzheimer, les neurosciences, la long evit e, l endocrinologie et le cancer. Par ailleurs, la Fondation Ipsen a initi e, `a partir de 2007, plusieurs s eries de r eunions en partenariat avec le Salk Institute, le Karolinska Institutet, le Massachusetts General Hospital, la Fondation DMMGF, ainsi qu’avec les revues Nature, Cell et Science. La Fondation Ipsen a publi e plus d’une centaine d’ouvrages et a attribu e plus de 250 prix et bourses. Vous trouverez plus d informations sur notre site Web : .fondation-ipsen.org

Thursday, July 10, 2014

Research and Markets Cancer Anorexia Global Clinical Trials Review, H1, 2014

Research and Markets Cancer Anorexia Global Clinical Trials Review, H1, 2014


. Buy Hair Vitamins online About Nolvadex (Tamoxifen) with no prescription DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/5vxfdw/cancer_anorexia) has announced the addition of the "Cancer Anorexia Global Clinical Trials Review, H1, 2014" report to their offering. Our clinical trial report, Cancer Anorexia Global Clinical Trials Review, H1, 2014" provides data on the Cancer Anorexia clinical trial scenario. http://webmdhelp.wordpress.com Buy Norlutate (Norethindrone Acetate) with free Rx This report provides elemental information and data relating to the clinical trials on Cancer Anorexia. Buy Motilium (Domperidone) with free Rx It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Cancer Anorexia. Carbamazepine with no prescription This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by Our team of industry experts. Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. Scope Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type Listings of discontinued trials (suspended, withdrawn and terminated) Reasons to buy Understand the dynamics of a particular indication in a condensed manner Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more Obtain discontinued trial listing for trials across the globe Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies For more information visit .researchandmarkets.com/research/5vxfdw/cancer_anorexia

Research and Markets Chronic Subdural Hematoma Global Clinical Trials Review, H1, 2014


. Buy Hair Treatments online Buy Nizoral Cream (Ketoconazole) with free Rx DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/s6ktgl/chronic_subdural) has announced the addition of the "Chronic Subdural Hematoma Global Clinical Trials Review, H1, 2014" report to their offering. Our clinical trial report, Chronic Subdural Hematoma Global Clinical Trials Review, H1, 2014" provides data on the Chronic Subdural Hematoma clinical trial scenario. http://webmdconsult.wordpress.com Buy Nolvadex (Tamoxifen) with free prescription This report provides elemental information and data relating to the clinical trials on Chronic Subdural Hematoma. Moduretic (Amiloride, Hydrochlorothiazide) with free prescription It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Chronic Subdural Hematoma. Buy Carafate with no Rx This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by Our team of industry experts. Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. Scope Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type Listings of discontinued trials (suspended, withdrawn and terminated) Reasons to buy Understand the dynamics of a particular indication in a condensed manner Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more Obtain discontinued trial listing for trials across the globe Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies For more information visit .researchandmarkets.com/research/s6ktgl/chronic_subdural

Research and Markets Cognitive Impairment Global Clinical Trials Review, H1, 2014


. Buy Hair Loss Shampoo online About Nizoral (Ketoconazole) without prescription DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/k7zk4t/cognitive) has announced the addition of the "Cognitive Impairment Global Clinical Trials Review, H1, 2014" report to their offering. Our clinical trial report, Cognitive Impairment Global Clinical Trials Review, H1, 2014" provides data on the Cognitive Impairment clinical trial scenario. http://webmdreview.wordpress.com Nizoral Cream (Ketoconazole) without Rx This report provides elemental information and data relating to the clinical trials on Cognitive Impairment. About Mobic (Meloxicam) without prescription It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Cognitive Impairment. Buy Captopril with free Rx This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by Our team of industry experts. Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. Scope Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type Listings of discontinued trials (suspended, withdrawn and terminated) Reasons to buy Understand the dynamics of a particular indication in a condensed manner Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more Obtain discontinued trial listing for trials across the globe Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies For more information visit .researchandmarkets.com/research/k7zk4t/cognitive

Wednesday, July 9, 2014

La Jolla Pharmaceutical Company Announces Planned Initiation of Phase 3 Registration Program for LJPC-501 in Resistant Hypotension

La Jolla Pharmaceutical Company Announces Planned Initiation of Phase 3 Registration Program for LJPC-501 in Resistant Hypotension


SAN DIEGO--(BUSINESS WIRE)--La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the “Company” or “La Jolla”), a biotechnology company developing therapeutics targeting significant unmet, life-threatening diseases, today announced that the Company plans to begin a phase 3 registration program for LJPC-501 for the treatment of catecholamine-resistant hypotension (CRH), a new indication. Initiation of this registration program is the result of a recent meeting between the Company and the U.S. Food and Drug Administration at which agreement was reached that blood pressure is an appropriate primary endpoint for approval. “We are excited to begin a registration program in CRH,” said George F. Tidmarsh, M.D., Ph.D., President and CEO of La Jolla. Lopid (Gemfibrozil) “There are approximately 75,000-100,000 patients per year who suffer from CRH, and the prognosis is very poor. Lopressor (Metoprolol) without prescription We are excited to advance LJPC-501 into a registration trial for this significant unmet medical need.” Hypotension, if uncorrected, is life-threatening and occurs as the result of various underlying conditions such as blood loss due to trauma, septic shock, poor heart function or drug reactions. About Lariam (Mefloquine) with no Rx The first line of treatment is catecholamine infusion. About Butop without prescription Catecholamines are derived from the amino acid tyrosine and include epinephrine (adrenaline), norepinephrine (noradrenaline), and dopamine, which act as neurotransmitters that increase blood pressure. Buy General Allergies online While largely effective, some patients fail to respond to adequate doses and are defined as catecholamine-resistant. http://webmdreview.wordpress.com Furthermore, high doses of catecholamines can lead to cardiac and other toxicities, and can contribute to the high rate of mortality in these patients. Therefore, there is a major unmet need for a new pharmacological agent that can restore blood pressure while maintaining catecholamine doses at acceptable levels. LJPC-501 (angiotensin II) is a peptide agonist of the renin-angiotensin system that acts to stabilize blood pressure. One of the most widely prescribed classes of blood pressure medication, angiotensin converting enzyme inhibitors, inhibits the production of angiotensin II, thereby reducing blood pressure. A randomized, placebo-controlled pilot study of angiotensin II in 20 patients with catecholamine-resistant hypotension was presented at the 34th International Symposium on Intensive Care and Emergency Medicine by Dr. Lakhmir S. Chawla from George Washington University. This study demonstrated that the mean norepinephrine dose for the placebo cohort was 20.1 ± 16.8 μg/minute vs. 7.3 ± 11.9 μg/minute for the angiotensin II cohort (P = 0.022). This was the pre-defined primary endpoint and a surrogate measure of blood pressure effect. Approximately 80% of patients treated with angiotensin II experienced a rise in blood pressure compared to 10-20% with placebo. The most common adverse event was hypertension, which occurred in 20% of patients receiving angiotensin II. Due to the estimated size of the patient population in the United States for this indication, the Company has filed for Orphan Drug status for angiotensin II. Conference Call and Webcast The Company will hold an investor conference call and webcast at 8:00 AM Eastern Time/5:00 AM Pacific Time on Wednesday, July 9, 2014. You can participate on the call by either dialing (877) 359-9508 pin: 71366477 or click here for the webcast. 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. LJPC-501, the Company’s second product candidate, is a natural peptide being developed for the treatment of hepatorenal syndrome and CRH. LJPC-401, the Company’s third product candidate, is a natural peptide being developed for the treatment of iron overload. For more information on the Company please visit .ljpc.com. Forward-Looking Statement Safe Harbor This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operations. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause actual results to be materially different from these forward-looking statements. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Company s filings with the U.S. Securities and Exchange Commission (“SEC”), all of which are available free of charge on the SEC s web site .sec.gov. These risks include, but are not limited to: risks relating to the development of GCS-100, LJPC-501 and LJPC-401; the success and timing of future preclinical and clinical studies of these compounds, and potential indications for which GCS-100, LJPC-501 and LJPC-401 may be developed; the ability of the Company to secure the necessary intellectual property rights to commercialize its product candidates, if successfully developed; and the ability to successfully obtain Orphan Drug status for LJPC-501. Subsequent written and oral forward-looking statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in the Company s reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.

Tuesday, July 8, 2014

CEL-SCI Receives Regulatory Clearance to Expand CEL-SCI’S Phase III Head and Neck Cancer Trial into Austria

CEL-SCI Receives Regulatory Clearance to Expand CEL-SCI’S Phase III Head and Neck Cancer Trial into Austria


VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT:CVM) today announced that it has received regulatory clearance from the Austrian Federal Office for Safety in Health Care to begin patient enrollment in the Company’s Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). Austria is the 14th country to participate in CEL-SCI’s trial which is already active in numerous clinics around the world. CEL-SCI’s Phase III trial is assessing the use of the Company’s Multikine immunotherapy as a first line treatment for patients diagnosed with advanced primary head and neck cancer, prior to standard of care, which involves surgery, chemotherapy, and/or radiation therapy. If approved for use following completion of CEL-SCI s clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body s natural immune system in the fight against tumors. There were more than 150,000 new patients diagnosed with head and neck cancer in Europe in 2012 according to the European Head and Neck Society’s (EHNS) Makes Sense Campaign, sponsor of the 2nd Annual European Head and Neck Cancer Awareness Week September 22 – 26, 2014. The goal of the Makes Sense Campaign is to raise awareness of head and neck cancer symptoms in order to drive earlier diagnosis, which is a key factor in survival. Buy Duricef (Cefadroxil) without Rx According to the Makes Sense Campaign, if patients are diagnosed in the early stages of the disease there is an 80–90% survival rate. About Effexor (Venlafaxine) However 60% of people with head and neck cancer present with locally advanced disease at diagnosis, and 60% of those people diagnosed at an advanced stage die from the disease within five years. Dostinex (Cabergoline) with no Rx Key risk factors, as identified by the Makes Sense Campaign are smoking, alcohol, and human papillomavirus virus (HPV). “There is growing awareness in Europe of head and neck cancer, as well as our Phase III immunotherapy study for the disease. About Beconase with free Rx We recently were a Gold Sponsor of the European Congress on Head and Neck Oncology 2014 conference, which was also sponsored by the European Head and Neck Society. Buy Dong Quai online We are encouraged to see that the increasing number of head and neck oncologists, who already have experience with Multikine, are looking to enroll more of their patients in our study,” stated CEL-SCI Chief Executive Officer Geert Kersten. Further expansion of CEL-SCI’s Phase III head and neck cancer trial is underway with a goal to have a total of 880 patients enrolled through about 100 clinical centers through by the end of 2015. http://webmdconsult.wordpress.com Over 200 patients are already enrolled in, and being treated with Multikine. About Multikine Phase III Study The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only. About Multikine Multikine* (Leukocyte Interleukin, Injection) is an immunotherapeutic agent that is being tested in a randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI s clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body s natural immune system in the fight against tumors. CEL-SCI is aiming to complete enrollment of subjects to the Phase III head and neck cancer study by the end of 2015. The trial is expected to expand into a total of approximately 100 clinical centers in about 20 countries. In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the US Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI also announced that it entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV. About CEL-SCI Corporation CEL-SCI’s work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational therapy Multikine (Leukocyte Interleukin, Injection) is currently being studied in a pivotal Phase III clinical trial against head and neck cancer. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with Multikine treatment regimen as compared to subjects treated with current standard of care only is satisfied, the study results will be used to support applications which will be submitted to regulatory agencies in order to receive from these agencies commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine which are being investigated include cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the U.S. Navy under a CRADA (Cooperative Research and Development Agreement). CEL-SCI is also developing its LEAPS technology for the treatment of pandemic influenza and as a potential therapeutic vaccine against rheumatoid arthritis. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. For more information, please visit .cel-sci.com. * Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress. When used in this report, the words "intends," "believes," "anticipated", “plans” and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company s potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation s SEC filings, including but not limited to its report on Form 10- K for the year ended September 30, 2013. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

The Medicines Company Receives Market Authorization Renewal for AngioxВ® (Bivalirudin) from the European Medicines Agency and the European Commission


PARSIPPANY, N.J.--(BUSINESS WIRE)--The Medicines Company (NASDAQ:MDCO) today announced that the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP), and the European Commission have granted market authorization renewal for Angiox® (bivalirudin) following a review of the latest clinical, safety, and efficacy data, as well as the Angiox risk management plan. The CHMP recommendation for the renewal of the marketing authorization for Angiox reconfirms its favorable risk-benefit profile. Angiox is a direct thrombin inhibitor and is indicated in Europe as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. Angiox is also indicated in Europe for the treatment of adult patients with unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for urgent or early intervention. The renewal is applicable to Angiox in all Member States of the European Union/European Economic Area. Angiox has a favorable class 1B recommendation for use in STEMI and NSTEMI patients undergoing primary PCI in the European Society of Cardiology guidelines, which inform clinical decision making. In more than 20 years of clinical study, bivalirudin has been shown to provide comparable efficacy and reduced bleeding versus heparin with or without glycoprotein IIb/IIIa inhibitor (GPI) use in patients undergoing PCI. Bivalirudin has been studied in thirteen multi-center clinical trials and one-single center randomized clinical trial in more than 35,000 patients, supporting the use of bivalirudin in the PCI setting regardless of femoral or radial access site and type of P2Y12 inhibitor. In STEMI patients, bivalirudin has demonstrated the reduction of mortality out to three years, independent of bleeding status. In addition, large, observational, real-world registries have collected data from approximately 500,000 patients that also support these findings. ”The renewal issued by the EMA and CHMP underscores the clinical value and importance of Angiox in contemporary interventional cardiology,” said Simona Skerjanec, Pharm.D., Senior Vice President and Acute Cardiovascular Care Global Innovation Group Leader at The Medicines Company. “Angiox continues to be a critical antithrombin option for interventional cardiologists globally who rely on it as a part of their therapeutic armamentarium in the cath lab and PCI setting of care. Angiox has been shown to have similar ischemic outcomes and reduced bleeding complications vs. standard of care, as well as reduction in mortality in Horizons AMI. Its benefits are consistent with our mission to save lives, alleviate suffering, and improve the economics of healthcare globally.” About Angiox/Angiomax In Europe, Angiox currently is indicated as an anticoagulant for adult patients undergoing PCI, including patients with STEMI undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation MI planned for urgent or early intervention. Please see full prescribing information available at .angiox.com. In the United States, bivalirudin is marketed under the trade name Angiomax and is indicated in patients undergoing PCI with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA. In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding. In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. Please see full prescribing information for Angiomax, available at .angiomax.com. About The Medicines Company The Medicines Company s purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infection disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland. Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company s actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether physicians, patients and other key decision makers will accept clinical trial results and such other factors as are set forth in the risk factors detailed from time to time in the Company s periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company s Quarterly Report on Form 10-Q filed with the SEC on May 12, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements. Note: This press release was issued in the United States and is intended as reference information for U.S. investors and journalists.

Thursday, July 3, 2014

Samenvatting Trifarotene molecuul van Galderma is weesgeneesmiddel


. Aggrenox (Asprin, Dipyridamole) with free Rx LAUSANNE, Switzerland--(BUSINESS WIRE)--Galderma maakt bekend dat de Amerikaanse voedsel- en warenautoriteit (FDA) de status van weesgeneesmiddel heeft verleend aan Galderma s trifarotene molecuul voor de behandeling van aangeboren ichthyose. Buy Abilify with free prescription Naar aanleiding van deze beslissing implementeert Galderma een medisch ontwikkelingsplan, waarmee het zich verder toelegt op onderzoek naar nieuwe behandelingen van zeldzame ziektes. Buy Air Fresheners online Daarnaast komt het bedrijf tegemoet aan de behoeften van alle patiГ«nten met huidziektes. "Gezien de last van aangeboren ichthyose en het gebrek aan effectieve en makkelijk te gebruiken behandelingen, is het moeilijk met deze aandoening te leven. http://webmdconsult.wordpress.com Het doel van Galderma is daarom niet alleen een efficiГ«nte en veilige medische oplossing om de symptomen te verzachten, maar ook de verbetering van de kwaliteit van leven", zei directeur van Galderma Humberto C. About Advair Diskus (Fluticasone-Salmeterol) Antunes. Deze bekendmaking is officieel geldend in de originele brontaal. About Aggrenox (Asiprin - Dipyridamole) with no Rx Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal welke als enige juridische geldigheid beoogt.

Exercise for diversity


. http://webmdconsult.wordpress.com Buy Air Fresheners online Buy Abilify with free prescription Aggrenox (Asprin, Dipyridamole) with free Rx About Aggrenox (Asiprin - Dipyridamole) with no Rx About Advair Diskus (Fluticasone-Salmeterol) ercise and high levels of dietary protein have a beneficial effect on the gut by boosting its bacterial diversity, new research shows. Irish Researchers published in Gut found that professional athletes differed significantly from controls with respect to plasma creatine kinase (a marker of extreme exercise), and inflammatory and metabolic markers as well as having a higher diversity of gut microorganisms - CLICK HERE.

Monday, June 2, 2014

Klick Health Wins MIX M-Prize for Harnessing Big Data and Social Technologies

Klick Health today announced it won an Unlimited Human Potential Challenge M-Prize from the Management Innovation eXchange (MIX) for a case study on its transformative Genome enterprise operating system, entitled Loxitane (Loxapine) with no Rx How We Harnessed Big Data and Social Technology to Empower and Engage Employees.
“As ardent disciples of MIX co-founder Gary Hamel, we are absolutely thrilled by this honor and are extremely proud to be part of the MIX community of innovators striving to enrich management practices around the world”
“As ardent disciples of MIX co-founder Gary Hamel, we are absolutely thrilled by this honor and are extremely proud to be part of the MIX community of innovators striving to enrich management practices around the world,” Buy Lozol (Indapamide) without Rx said Klick Health CEO Leerom Segal.
Genome uses big data and social technologies to customize the employee experience, increase engagement, speed-up mastery of new skills, and maximize a team's success. Diflucan (Fluconazole) with no Rx It was recently profiled in the New York Times bestselling business book THE DECODED COMPANY: Know Your Talent Better Than You Know Your Customers (Portfolio/Penguin; February 2014), which reveals how a growing number of industry-leading companies are decoding employee work data in the same way that Facebook, Netflix, Spotify and other apps decode customer data to personalize, simplify and enhance the user experience.
This award is one of a growing number of accolades Klick has received for its enterprise operating systems, including the Nielsen Norman Group (NN/G) Acnelyse with free prescription Intranet of the Year award Klick won for the system it designed and built for Acorda Therapeutics.
In related news, Klick today also announced a new offering called Sensei Labs to help pre-commercial and rapidly scaling biotech companies evolve into optimized commercial entities with speed, precision, and confidence. Buy Vitamins online Sensei Labs offers consulting services and technology solutions to enhance the commercialization process and to enable rapidly transitioning companies to execute and evolve faster and focus on their core competencies.
About Klick Health
Klick Health is the world’s largest independent digital health agency, laser-focused on creating solutions that engage and educate about life-saving treatments. Klick helps inform and empower patients to manage their health and play a central role in their own care. future Pharmaceuticals Every solution hinges on Klick’s in-house expertise across the digital universe – strategy, creative, analytics, instructional design, user experience, relationship marketing, social and mobile.
Klick’s latest innovation, Sensei Labs, helps biotech companies evolve and execute faster using the data-driven, employee-centric philosophy outlined in the New York Times bestselling business book The Decoded Company (Portfolio/Penguin). Established in 1997, Klick has teams in Chicago, New Jersey, New York, Philadelphia, San Francisco and Toronto.