Thrasos Announces Successful Formal Interim Analysis and Clinical Update for Phase 2 Study of THR-184 for Acute Kidney Injury

MONTREAL--(BUSINESS WIRE)--Thrasos Therapeutics, a biotherapeutics company focused on delivering new solutions for kidney disease, today announced that a pre-planned formal interim analysis of 140 subjects enrolled in its Phase 2 clinical study of THR-184 for Acute Kidney Injury (AKI) has been completed. The study will now continue and the dosing strategy will be adjusted based on recommendations of the Independent Data Monitoring Committee (IDMC). At this time 200 subjects have been enrolled in the ongoing clinical trial. The interim analysis was conducted by an independent statistical team and reviewed with the IDMC. Buy Dilantin (Phenytoin) with free Rx It focused on the safety and efficacy of three original doses of THR-184 compared to placebo. About Diovan (Valsartan) with free prescription The IDMC recommended continuation of the study based on safety and further recommended that the study proceed using the original high dose arm, dropping the two lower dose arms. Buy Dexone (Dexamethasone) with no prescription Thrasos will continue the study as recommended by the IDMC and will add a higher dose arm, expanding the study to a total of approximately 450 subjects. “I am pleased that the IDMC was able to complete its assessment of the safety and potential efficacy of THR-184 in the Phase 2 trial, and particularly pleased that the Committee determined, based on the observed safety profile, that additional subjects could be enrolled,” said Glenn Chertow, Professor of Medicine and Chief, Division of Nephrology, Stanford University School of Medicine. THR-184 is a small proprietary peptide that acts on the BMP/Smad pathway. About Desloratadine with no Rx It is in development for the prevention and treatment of AKI. Buy Soap online Results from a broad set of preclinical studies, as well as two, Phase 1 clinical trials in which THR-184 was found to be safe and well-tolerated, led to the design and initiation of this Phase 2 clinical trial. http://mdreview.wordpress.com The trial is expected to enroll up to 450 patients at more than 40 sites in Canada and the United States. The trial is focused on the prevention of AKI in patients undergoing cardiac surgery. Earlier this year, THR-184 was granted Fast Track designation for this indication by the U.S. Food and Drug Administration (FDA). “The incidence of acute kidney injury following cardiac surgery is a serious concern for patients and physicians; the potential of THR-184 to prevent this complication is very exciting,” said Jean-Claude Tardiff, Director of the Montreal Heart Institute Research Centre, Universit e de Montr eal and Co-Chair of the Study Committee. “The successful outcome of this interim analysis is an important step in moving this program forward to a more complete understanding of the potential of this therapy.” “We are very pleased with the progress of this Phase 2 study. The Company has worked closely with the experts on its Steering Committee to bring us to this stage. And, this trial has been carefully designed to evaluate the safety, tolerability and efficacy of different doses of THR-184,” said Jens Eckstein, Ph.D., President, SR One and Chairman of the Board of Thrasos. “We are looking forward to the next stage of this Phase 2 program.” About Acute Kidney Injury (AKI) Acute kidney injury (AKI) is the sudden loss of kidney function, and it affects more than 1.2 million people each year in the United States. It occurs in different situations and is particularly frequent in patients hospitalized for major surgery, including cardiac and/or vascular surgery, trauma, infection, cardiac disease or cancer. Acute kidney injury can lead to permanent reduction of kidney function and is also associated with an increased risk of death, extended hospitalization and significantly increased medical cost. There are currently no available therapies to prevent or treat AKI. About Thrasos Thrasos is a privately held, clinical-stage biotherapeutics company focused on delivering new solutions to individuals affected by kidney disease. The company’s lead compound, THR-184, is currently being evaluated in a Phase 2 clinical study for the prevention of acute kidney injury in patients undergoing cardiac surgery. Thrasos is also developing compounds for diabetic nephropathy, a major cause of chronic kidney disease. .thrasos.com

Lannett Receives FDA Approval for Oxycodone Hydrochloride Capsules 5 mg

PHILADELPHIA--(BUSINESS WIRE)--Lannett Company, Inc. (NYSE: LCI) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride Capsules, 5 mg, the therapeutic equivalent to the reference listed drug, Oxycodone Hydrochloride Capsules, 5 mg, of Lehigh Valley Technologies, Inc. Buy Clarinex (Desloratadine) with free prescription According to IMS, for the year ended June 2014 total sales of Oxycodone Hydrochloride Capsules, 5 mg, at Average Wholesale Price (AWP) were approximately $7.1 million. Buy Claritin (Loratadine) with no prescription The company expects to commence shipping the product in the coming months. “Oxycodone Hydrochloride Capsules, 5 mg, represents our third product approved by the FDA thus far in 2014, and, importantly, adds to our goal of vertical integration,” said Arthur P. About Cialis Sublingual (Tadalafil) Bedrosian, president and chief executive officer of Lannett. Decaderm with free prescription “We hope to receive additional product approvals in the near future while we continue to develop our robust pipeline.” About Lannett Company, Inc.: Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. Buy Sage online For more information, visit the company’s website at .lannett.com. This news release contains certain statements of a forward-looking nature relating to future events or future business performance. http://mdreview.wordpress.com Any such statement, including, but not limited to, successfully commercializing Oxycodone Hydrochloride Capsules, 5 mg, and the receipt of product approvals in coming months, whether expressed or implied, is subject to market and other conditions, and subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the risk factors discussed in the Company’s Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC. These forward-looking statements represent the Company s judgment as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements.

Cellectis Sells Its Swedish Subsidiary, Cellectis AB, to the Japanese Company Takara Bio Inc.

PARIS--(BUSINESS WIRE)--Regulatory News: Cellectis (Paris:ALCLS)(Alternext: ALCLS.PA), a leader in the development of adoptive immunotherapies based on engineered allogeneic CART cells (UCART) announces today the sale of its subsidiary Cellectis AB to the Japanese Company Takara Bio Inc. This operation, which will be realized in the coming weeks subject to the completion of certain usual conditions, is for Cellectis the extension to its strategic therapeutic focus. The Company now concentrates its activities in the field of oncology through the development of Chimeric Antigen Receptor T-cell (CAR-T) immunotherapy products generated through its allogeneic CAR-T platform, both on its own as well as in partnership with Servier and Pfizer. Cellectis AB is a biotechnology company focused on applications of human embryonic stem cell (hES) based products and technologies for the Industry and the research community. The quick downturn of the market had led Cellectis SA to restructure in 2013 its heavily loss-making “Tools and Services” Business Unit. The sale of Cellectis AB is the last step of the reorganization of this Business Unit which in 2013 recorded an operating loss of 14 million euros before booking of extraordinary depreciation and of the costs related to the company downsizing. The financials terms of the transaction have not been disclosed. Azulfidine (Sulfasalazine) with no prescription It will lead to a loss of about € 5 million in 2014 Cellectis’ books. About Cellectis Cellectis is a biopharmaceutical company focused on oncology. About Bactrim (Trimethoprim And Sulfamethoxazole) without Rx The company’s mission is to develop a novel generation of therapies based on engineered T-cells to treat cancer. Buy Azulfidine (Sulfasalazine) without prescription Cellectis capitalizes on its 14 years of expertise in genome engineering, based on TALEN™, meganucleases and the state-of-the-art electroporation technology Pulse Agile, to create a new generation of cancer immunotherapy for treating leukemias and solid tumors. About Cyclophil Cellectis’ adoptive cancer immunotherapy for chronic and acute leukemias is based on the first allogeneic T-cell chimeric antigen receptor (CAR) technology. Buy Pre Workout online CAR technologies are designed to target surface antigens expressed on cells. http://mdreview.wordpress.com These treatments reduce toxicities associated with current chemotherapeutics and have the potential for curative therapies. The Cellectis Group is focused on life sciences and uses leading genome engineering technologies to build innovative products in various fields and markets. Cellectis is listed on the NYSE Alternext market (ticker: ALCLS). To find out more about us, visit our website: .cellectis.com Disclaimer This press release and the information contained herein do not constitute an offer to sell or subscribe, or a solicitation of an offer to buy or subscribe for shares in Cellectis in any country. This press release contains forward-looking statements that relate to the Company’s objectives based on the current expectations and assumptions of the Company’s management only and involve unforeseeable risk and uncertainties that could cause the Company to fail to achieve the objectives expressed by the forward-looking statements.

Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Announce Strategic Immuno-Oncology Collaboration in Japan, South Korea and Taiwan

NEW YORK & OSAKA, Japan--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Ono Pharmaceutical Co., Ltd. (“Ono”) have signed a strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens to help address the unmet medical needs of patients with cancer in Japan, South Korea and Taiwan. As part of the agreement, Bristol-Myers Squibb and Ono will jointly develop and commercialize Opdivo (nivolumab) and Yervoy (ipilimumab) across a broad range of tumor types. Opdivo is a PD-1 immune checkpoint inhibitor approved in Japan for the treatment of patients with unresectable melanoma, making it the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world, and is being developed in multiple tumor types in more than 35 clinical trials. Azulfidine (Sulfasalazine) with no prescription Yervoy, a CTLA-4 immune checkpoint inhibitor, is approved in Taiwan for the treatment of patients with advanced melanoma who have received prior therapy, and is in late-stage development as a potential treatment option for melanoma, small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) in Japan. About Bactrim (Trimethoprim And Sulfamethoxazole) without Rx The agreement includes three additional early-stage clinical immuno-oncology assets from Bristol-Myers Squibb: lirilumab, an antibody that blocks the KIR receptor on natural killer cells, urelumab, an agonist of the CD137 co-stimulatory receptor, and BMS-986016, a LAG3 immune checkpoint inhibitor. Bristol-Myers Squibb and Ono will jointly pursue development of monotherapy and combination regimens, with Opdivo as the foundational therapy in Japan, South Korea and Taiwan, and leverage global clinical trials by including patients from the three countries. “Bristol-Myers Squibb’s collaboration with Ono supports our goal to maximize the full potential of our immuno-oncology portfolio for patients worldwide,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. Buy Azulfidine (Sulfasalazine) without prescription “This collaboration combines our leadership in immuno-oncology with both companies’ experience and capabilities in Asia, and strengthens our long-standing relationship with Ono.” “Our collaboration with Bristol-Myers Squibb strengthens our ability to further enhance the potential of Opdivo, for which Ono recently received manufacturing and marketing approval in Japan as the first PD-1 inhibitor approved anywhere in the world,” said Gyo Sagara, President, Representative Director and CEO, Ono. About Cyclophil “By pursuing the study of investigational combination regimens of immunotherapies with Bristol-Myers Squibb, we hope to bring a range of new therapeutic options to cancer patients.” Under the terms of the agreement, Bristol-Myers Squibb and Ono will jointly develop and commercialize all collaboration products in Japan, South Korea and Taiwan. Buy Pre Workout online Development costs and commercial profits will be shared equally when Opdivo is used in combination with any Bristol-Myers Squibb compound (Yervoy, lirilumab, urelumab, BMS-986016). http://mdreview.wordpress.com For a Bristol-Myers Squibb compound used as monotherapy, or two Bristol-Myers Squibb compounds used in a combination regimen, Bristol-Myers Squibb will fund the substantial majority of development costs and receive the substantial majority of commercial profits. When Opdivo is used as a single agent, Ono will fund the substantial majority of development costs and receive the substantial majority of commercial profits. Prior to this announcement, Ono held exclusive rights to develop and commercialize Opdivo in Japan, South Korea and Taiwan while Bristol-Myers Squibb held such rights in the rest of the world, along with sole rights to develop and commercialize Yervoy, lirilumab, urelumab, and BMS-986016 worldwide. The trade name Opdivo has been proposed in the U.S. and other countries, but remains subject to health authority approval. About Opdivo (nivolumab) Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo is an investigational human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. The companies are investigating whether by blocking this pathway, Opdivo would enable the immune system to resume its ability to recognize, attack and destroy cancer cells. Opdivo was approved in Japan on July 4, 2014 for the treatment of patients with unresectable melanoma and is being studied in multiple tumor types in more than 35 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in NSCLC, melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin lymphoma. In 2013, the FDA granted Fast Track designation for Opdivo in NSCLC, melanoma and RCC. In May 2014, the FDA granted Opdivo Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab. About Yervoy (ipilimumab) Yervoy, which is a recombinant, human monoclonal antibody, blocks the cytotoxic T- lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of Yervoy’s effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumor immune responses. On March 25, 2011, the FDA approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is now approved in more than 40 countries, including Taiwan. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types. This includes Phase 3 trials in prostate and lung cancers. Yervoy (ipilimumab) INDICATION & IMPORTANT SAFETY INFORMATION Yervoy (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma. Important Safety Information WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS Yervoy can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of Yervoy. Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs) and thyroid function tests at baseline and before each dose. Permanently discontinue Yervoy and initiate systemic high-dose corticosteroids for sever immune-mediated reactions. Recommended Dose Modifications Withhold dose for any moderate immune-mediated adverse reactions or for symptomatic endocrinopathy until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue Yervoy for any of the following: Persistent moderate adverse reactions or inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day Failure to complete full treatment course within 16 weeks from administration of first dose Severe or life-threatening adverse reactions, including any of the following: Colitis with abdominal pain, fever, ileus, or peritoneal signs; increase in stool frequency (>=7 over baseline), stool incontinence, need for intravenous hydration for >24 hours, gastrointestinal hemorrhage, and gastrointestinal perforation AST or ALT >5 x the upper limit of normal (ULN) or total bilirubin >3 x the ULN Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full-thickness dermal ulceration or necrotic, bullous, or hemorrhagic manifestations Severe motor or sensory neuropathy, Guillain-Barr e syndrome, or myasthenia gravis Severe immune-mediated reactions involving any organ system Immune-mediated ocular disease which is unresponsive to topical immunosuppressive therapy Immune-mediated Enterocolitis: In the pivotal Phase 3 study in Yervoy-treated patients, severe, life-threatening, or fatal (diarrhea of >=7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 (5%) patients Across all Yervoy-treated patients (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis Infliximab was administered to 5 of 62 (8%) patients with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms Permanently discontinue Yervoy in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to

Puma Biotechnology Announces Amendment to Neratinib Licensing Agreement with Pfizer

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE:PBYI), a development stage biopharmaceutical company, announced an amendment to its licensing agreement with Pfizer for Puma s investigational drug PB272 (neratinib). Puma is currently developing PB272 for the treatment of patients with HER2-positive breast cancer and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation. At the time that Puma licensed PB272 from Pfizer, a number of ongoing clinical trials (legacy clinical trials) that had been previously initiated by Pfizer were transferred to Puma. Buy Advair Diskus (Fluticasone-Salmeterol) without prescription The original license agreement set a limit on the amount of external expenses that Puma would incur in completing these legacy clinical trials. Buy Aggrenox (Asiprin - Dipyridamole) without prescription Puma reached this limit in the fourth quarter of 2012. About Aggrenox (Asprin, Dipyridamole) with no Rx The original license agreement also provided that Pfizer would be responsible for all expenses for these ongoing legacy trials above the pre-determined limit until the trials were completed. The amendment to the license agreement provides that Puma will now be solely responsible for the expenses associated with the ongoing legacy clinical trials. Cordarone with no Rx Puma anticipates that this will result in an increase in research and development expenses, which will total approximately $30 million. Buy Organic Tea online Puma further anticipates that a significant percentage of this approximately $30 million will occur in 2014 and will decrease over time until the trials are completed. In addition, according to the terms of the original license agreement, upon commercialization of neratinib, Puma is obligated to pay Pfizer incremental annual royalties ranging between 10 to 20 percent of net sales of neratinib. http://mdreview.wordpress.com Under the terms of the amendment to the license agreement, upon commercialization of neratinib, Puma will be obligated to pay Pfizer annual royalties on net sales of neratinib at a fixed rate in the low- to mid- teens. “We are pleased to enter into this amendment to the licensing agreement for neratinib. By assuming responsibility for the expenses associated with the ongoing legacy clinical trials, and by fixing the royalty rate for the drug at a reduced rate, we believe that we have significantly improved the potential value of the drug,” said Alan H. Auerbach, Chief Executive Officer and President. Conference Call and Webcast Puma Biotechnology will host a conference call to discuss the amendment to the license agreement for neratinib at 2:00 p.m. PDT (5:00 p.m. EDT) on Tuesday, July 22, 2014. The conference call may be accessed by dialing 1-877-709-8150 for domestic callers and 1-201-689-8354 for international callers. Please specify to the operator that you would like to join the “Puma Biotechnology Update Call.” The conference call will also be webcast live and accessible through the Investor Relations section of Puma’s website at .pumabiotechnology.com/ir_events.html and will be archived there for 30 days following the call. Please visit Puma’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. About Puma Biotechnology Puma Biotechnology, Inc. is a development stage biopharmaceutical company that acquires and develops innovative products for the treatment of various forms of cancer. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. The Company is initially focused on the development of PB272 (oral neratinib), a potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2-positive breast cancer and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation. Further information about Puma Biotechnology can be found at .pumabiotechnology.com. Forward-Looking Statements: This press release contains forward-looking statements, including statements regarding the anticipated increases in, the timing of the increases in and the decrease over time in research and development expenses. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing; the Company’s dependence on PB272, which is still under development and may never receive regulatory approval; the challenges associated with conducting and enrolling clinical trials; the risk that the results of clinical trials may not support the Company’s drug candidate claims; even if approved, the risk that physicians and patients may not accept or use the Company’s products; the Company’s reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates; the Company’s dependence on licensed intellectual property; and the other risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2013. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.

Terumo BCT abre nueva planta de fabricaci'on en Vietnam

. http://mdreview.wordpress.com LAKEWOOD, Colorado--(BUSINESS WIRE)--Terumo BCT, l ider mundial en componentes de la sangre, af eresis terap eutica y tecnolog ias celulares, anunci o hoy la inauguraci on de su nueva planta de 91 440 metros cuadrados cerca de Ciudad Ho Chi Minh, Vietnam. La planta de fabricaci on de 100 millones USD respalda la expansi on de Terumo BCT a nivel mundial. Cuando comiencen las operaciones de fabricaci on a principios de 2015, la nueva planta de fabricaci on ofrecer a mayor capacidad de producci on. Hechos clave: Terumo BCT es un fabricante mundial de dispositivos m edicos con sede en Lakewood, Colorado. Las sedes regionales se encuentran en: Bruselas, Buenos Aires, Hong Kong y Tokio. Con una inversi on de 100 millones USD, Terumo BCT ha construido una planta de 91 440 metros cuadrados ubicada cerca de Ciudad Ho Chi Minh en un area de 10 hect areas. Una vez que cuente con todo el personal, se espera que el edificio albergue a m as de 900 asociados nuevos. Con la inauguraci on de la planta de Vietnam, los productos de Terumo BCT se fabricar an en siete pa ises: B elgica, China, India, Jap on, Irlanda del Norte, los Estados Unidos y Vietnam. En Vietnam, se fabricar an materiales desechables y bolsas de sangre entera para extracciones automatizadas. Actualmente, Terumo BCT tiene m as de 4800 asociados y atiende tres segmentos primarios de clientes en m as de 120 pa ises y territorios: centros de sangre, af eresis terap eutica y extracciones automatizadas, y procesamiento de c elulas. La planta de Vietnam es parte de una estrategia m as amplia de Terumo BCT que incluye inversiones en sus operaciones de fabricaci on existentes en los EE. UU., en sus sedes globales en Colorado, y sus plantas de fabricaci on en Irlanda del Norte y la India. Citas clave: Craig Rinehardt, Vicepresidente Ejecutivo de Operaciones Globales, Terumo BCT “La finalizaci on de esta planta de fabricaci on representa un compromiso continuo para con nuestros clientes en todos los continentes, al brindar la capacidad global y mejorar la t ecnicas de fabricaci on que se usar an en Vietnam para aumentar la velocidad en la que llegan los productos al mercado y perfeccionar nuestra capacidad de cumplir con las necesidades de los clientes”. “Iniciamos y completamos la construcci on en menos de un a~no. Cialis Daily (Tadalafil) Con la ayuda de muchos, hemos dado vida a esta inversi on y nos emociona abrir nuestras puertas a la planta de fabricaci on de Vietnam, una muy buena incorporaci on a nuestras sedes de fabricaci on de los EE. UU., y a nuestras operaciones globales”. Yutaro Shintaku, Presidente y Director Representante, Terumo Corporation “La nueva planta de Vietnam de Terumo BCT es el ejemplo m as reciente de c omo Terumo Corporation est a invirtiendo en sus capacidades a nivel mundial, y la inauguraci on de esta planta es un nuevo y emocionante paso para nosotros. Cialis Professional (Tadalafil) without prescription Somos optimistas con respecto a las oportunidades que esta nueva planta nos brinda para formar parte del crecimiento de la regi on y para vivir nuestra misi on de contribuir con la sociedad a trav es de la atenci on m edica”. Recursos clave: Fotograf ias de la planta de Vietnam, 2014 Inicio de la construcci on en Vietnam, 2013 Inversi on de Terumo BCT en Colorado Inversi on de Terumo BCT en Irlanda del Norte Acerca de Terumo BCT: Terumo BCT, l ider global en componentes de la sangre, af eresis terap eutica y tecnolog ias celulares, es la unica empresa con la combinaci on exclusiva de recolecciones por af eresis, procesamiento manual y automatizado de sangre entera y reducci on de pat ogenos. Wellbutrin Sr (Bupropion) Creemos que la sangre tiene un potencial para hacer a un m as por los pacientes de lo que hace hoy. Clotrimazole without prescription Esta creencia inspira nuestra innovaci on y fortalece nuestra colaboraci on con los clientes. El texto original en el idioma fuente de este comunicado es la versi on oficial autorizada. Buy Multi Oil Blends online Las traducciones solo se suministran como adaptaci on y deben cotejarse con el texto en el idioma fuente, que es la unica versi on del texto que tendr a un efecto legal.

Research and Markets Late-Stage Four-FCritical Care Therapeutics in Major Developed Markets to 2020

DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/lzxd54/latestage) has announced the addition of the "Late-Stage Four-FCritical Care Therapeutics in Major Developed Markets to 2020 - New andactor PCCs and Recombinant Products to Drive Market" report to their offering. The critical care market in the eight major developed markets (the US, UK, France, Germany, Italy, Spain, Japan and Canada) was worth an estimated $1.8 billion in 2013 and is expected to grow to $2.5 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 4.7%. The majority of this revenue was due to albumin sales which amounted to $1.1 billion in 2013 and are expected to grow to $1.6 billion by 2020. In terms of markets, the US held the largest share with 41% of the total critical care market in 2013 and is projected to grow at the highest rate of any market at 7.5% during the 2013-2020 period. Albumin was used to treat the highest share of the critical care treatment population across all eight markets with 2.2 million patients of a total of 2.4 million in 2013. Buy Dilantin (Phenytoin) with free Rx Expectedly, the highest share of these patients was in the US, a total of 46% in 2013. About Diovan (Valsartan) with free prescription A further 39.3% of the 2013 treatment population were located in the top five countries of Europe, followed by Japan with 9.5% and rest from Canada. Buy Dexone (Dexamethasone) with no prescription The treatment population in the US is estimated to grow at a CAGR of 0.9% until 2020 with highest growth expected in the number of patients treated with Prothrombin Complex Concentrate (PCC) which is expected to grow at a CAGR of 2%. About Desloratadine with no Rx Globally, the treatment population receiving Anti-Thrombin (AT) concentrates and PCCs is expected to be larger than any other category and will grow at a CAGR of 1.5% during the 2013-2020 period. The projected high growth rate of revenues in the US market of 7.5% is mainly due the increased uptake of factor concentrates over older alternatives (such as Fresh-Frozen Plasma (FFP)), higher price inflation and the launch of new drugs such as Kcentra (PPC, human) and Tretten (Factor XIII concentrate, recombinant) in 2013. Buy Soap online Kcentra is the first four-factor PCC in the US and Tretten is the first recombinant factor XIII concentrate. http://mdreview.wordpress.com In the top five European critical care markets there have been no recent significant product launches and none are expected during the forecast period. These markets are therefore anticipated to grow slowly during the forecast period, the UK market will grow at a CAGR of 3.0%, followed by France at 2.5%, Germany and Spain will each grow at 2.3% and Italy at 2.0%. Key Topics Covered: 1 Tables & Figures 2 Introduction Albumin in Critical Care Anti-Thrombin III Concentrates in Critical Care Factor XIII Concentrates in Critical Care Fibrinogen Concentrates in Critical Care Prothrombin Complex Concentrate in Critical Care 3 Therapeutic Landscape Albumin Products Anti-Thrombin Concentrates Factor XIII Concentrates Fibrinogen Concentrates Prothrombin Complex Concentrates 4 Pipeline for Critical Care Market Overview of Pipeline Promising Pipeline Candidates 5 Critical Care Market Forecast to 2020 Geographical Markets Drivers and Barriers 6 Deals and Strategic Consolidations 7 Appendix Companies Mentioned Bain Capital Baxter BioRx Biomat CSL Behring Cangene Grifols Inspiration Biopharma Ipsen Novartis Octapharma Pfizer Plasma Resources Sangamo BioSciences Sanquin Shin Poong Pharmaceutical Shire For more information visit .researchandmarkets.com/research/lzxd54/latestage

Teva Announces FDA Acceptance of NDA Filing for Investigational Short-Acting Beta-Agonist (SABA) Inhaler (Albuterol MDPI)

JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceuticals Industries Ltd., (NYSE:TEVA) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s new drug application (NDA) for albuterol multi-dose dry-powder inhaler (MDPI), an investigational breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm (EIB) in patients 12 years of age and older. “We are extremely pleased the FDA has accepted for review the NDA for albuterol MDPI. If approved, albuterol MDPI would become the first breath-actuated dry-powder symptomatic and rescue inhaler available to asthma patients,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. Cialis Daily (Tadalafil) “As the current market-leader in asthma rescue inhalers, it is our hope that the new dry-powder innovation utilized with albuterol MDPI will help fill an unmet need in the existing asthma market.” The NDA filing includes data from eight clinical studies that evaluated the safety and efficacy of albuterol MDPI in adults and adolescents (12 years of age and older) with asthma and exercise-induced bronchospasm (EIB). Cialis Professional (Tadalafil) without prescription The NDA for albuterol MDPI has been accepted by the FDA for standard review, with a FDA Regulatory Action expected in March 2015. About Asthma Asthma is a chronic (long-term) disease of inflammation of both the large and small airways of the lung, characterized by symptoms of wheezing and coughing. Wellbutrin Sr (Bupropion) Asthma causes recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath and coughing that often occurs at night or early in the morning. Clotrimazole without prescription Without appropriate treatment, asthma symptoms may become more severe and result in an asthma attack, which can lead to hospitalization and even death. About Teva Teva Pharmaceutical Industries Ltd. Buy Multi Oil Blends online (NYSE:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. http://mdreview.wordpress.com Headquartered in Israel, Teva is the world s leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva s Specialty Medicines businesses focus on CNS, respiratory oncology, pain, and women s health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013. Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our innovative products, especially COPAXONE® (including competition from orally-administered alternatives, as well as from potential purported generic equivalents); the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from the research and development efforts invested in our pipeline of specialty and other products; our ability to reduce operating expenses to the extent and during the timeframe intended by our cost reduction program; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; our potential exposure to product liability claims that are not covered by insurance; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; uncertainties related to our recent management changes; the effects of increased leverage and our resulting reliance on access to the capital markets; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; the impact of continuing consolidation of our distributors and customers; significant impairment charges relating to intangible assets and goodwill; potentially significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2013 and in our other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and we assume no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Great Success for the First Edition of “French Life Sciences Days”

PARIS--(BUSINESS WIRE)--France Biotech, (.france-biotech.org), an association of entrepreneurs in the life sciences industry, today announced the high level of interest in the first edition of “French Life Sciences Days” on June 25th and 26th in New York and is pleased to announce the event renewal next year on June 17th and 18th in New York. This brand new initiative allowed 19 Life Sciences companies, recently listed or more mature, with a market capitalization from Euro 25 to 477 million, developing Biotech and Medtech breakthrough technologies with advanced clinical results or sales. Their CEOs have displayed their business plans to 50 American non-specialized and specialized financial investors. Our firms’ investment opportunities have attracted prestigious names of Finance from Boston, New York and Philadelphia. These investors showed a tremendous interest in the 19 innovative companies during 70 one-to-one meetings (about 4 meetings per company).This first edition has also been broadly covered in French and American media (Forbes, The Wall Street Journal: on.wsj.com/1wBk3UW, Reuters, Les Echos, La Tribune, and a specific coverage from BFM Business). “The Life Sciences Days are a major element in promoting and reinforcing the whole innovative SMEs funding scene, from startup to more mature companies. About Ventolin (Albuterol (Salbutamol)) with no Rx Our goal has been achieved: French innovation in the healthcare field has been recognized in the United States and the investors are convinced that world future champions are among us! The French financial players confirm Euronext’s leading position. About Vepesid (Etoposide) with no Rx This event’s success calls for further ones and we will renew this event on June 17th and 18th 2015 in New York and already plan the same initiative in Asia. Timoptic (Timolol) I particularly thank our sponsors, Bryan Garnier & Co, Soci et e G en erale, Invest Securities, Deloitte, Mazars and NewCap who have been key to this success!”, Pierre-Olivier Goineau, the president of France Biotech, said. About the “French Life Sciences Days”This new initiative by France Biotech aims at fostering and boosting the connections between French public companies and investors worldwide in an effort to facilitate exchanges and demonstrate the solidity of our own financial community. About Citol with no prescription The first edition will be held in New York. Buy Male Performance online This “French Life Sciences Days” initiative brings together key Parisian players (banks, brokers, analysts, auditors, lawyers and communication agencies) to form a sponsorship committee that will support entrepreneurs in the life sciences. http://mdreview.wordpress.com During this occasion, the French biotech and medtech companies listed on the NYSE Euronext exchange will introduce themselves to international investors. About France BiotechFrance Biotech brings together the main French life science companies and their expert partners. Its mission is to support the development of the French life sciences by advocating for a favorable regulatory and fiscal environment. In 2004, France Biotech successfully lobbied the French government to create a special fiscal status for innovative start-ups and continues to act as an advocate for the French innovative sector. The organization is currently chaired by Pierre-Olivier Goineau, Co-Founder and CEO of ERYTECH Pharma. France Biotech has over 150 members and its board of directors is composed of 20 entrepreneurs in the life sciences.

Global Genes Hosts Third Annual Tribute to Champions of Hope Gala

ALISO VIEJO, Calif.--(BUSINESS WIRE)--On September 13th, 2014, over 600 attendees will gather at the Hyatt Regency Resort and Spa in Huntington Beach, CA, for the third annual Tribute to Champions of Hope Gala, hosted by Global Genes™. This annual sold-out event brings together rare disease stakeholders including patients, advocates, biotech and pharmaceutical executives, rare disease researchers, celebrities, and philanthropists. The Tribute to Champions of Hope Gala celebrates the pioneering achievements of individuals and corporations in the rare and genetic disease community who are leading the fight against rare disease. This event continues to raise awareness for the over 7,000 different types of rare diseases that affect roughly 30 million Americans and approximately 350 million people worldwide. Proceeds from the evening will benefit Global Genes’ educational programs, as well as the innovative Undiagnosed Patient Program, which aims to support the start of the rare disease journey for undiagnosed patients through direct funding for complex diagnostics, including genome sequencing. Global Genes is pleased to announce the evening award recipients: RARE Champion of Hope – Industry Trailblazer, Dr. About Neurontin (Gabapentin) without prescription Moncef Slaoui, Chairman, Global Research & Development and Vaccines, GlaxoSmithKline. Buy Nexium (Esomeprazole) with no prescription Moncef Slaoui has led the transformation and commitment to rare disease within one of the world’s largest pharmaceutical companies. Microzide (Hydrochlorothiazide) with free prescription Because of his leadership, over 50 rare disease therapies are now in development. Buy Capecitabine with free prescription He is a true champion for rare disease, and a symbol of what steadfast commitment, desire and smarts can accomplish for a community in need. RARE Champion of Hope – Collaborations in Advocacy, Carolyn Levering, President & CEO, The Marfan Foundation. Buy Gymnema Sylvestre online Led by Carolyn Levering, The Marfan Foundation is a best-in-class example of collaboration in advocacy. http://medicalquestionanswers.wordpress.com The Marfan Foundation in conjunction with Univision, Mayo Clinic, and the Larson Family, set out to expand their reach and spread their message to the Spanish-speaking community. Through this partnership, they created an entire pilot program that included extensive national and local broadcast, print, and online media coverage, materials for the Spanish-speaking community, and a Spanish-language track at the Foundation’s Annual Family Conference in Los Angeles in August 2013. This collaboration brought together an advocacy organization, a large media company, a leading medical institution, and a family to reach an under-served segment of their patient population in a much more interactive way. RARE Champion of Hope – Collaborations in Science, David Altshuler, M.D., Ph.D., Chair, Steering Committee and Peter Goodhand, Executive Director, Global Alliance for Genomics and Health (GAGH). Spearheading the creation and development of the GAGH in 2013, they have together established the first collaborative organization to enable the sharing of genomic and clinical data to help unlock potential advancements in medicine and science. Today, the GAGH is comprised of more than 193 partner organizations based in 28 countries including healthcare, biomedical research, disease and patient advocacy, life science and information technology. RARE Champion of Hope – Public Service, David Williams, President and CEO, Make-A-Wish® America. Make-A-Wish grants the wishes of children diagnosed with life-threatening medical conditions, many of which are rare diseases--enriching their lives and bringing hope. Last year alone, Make-A-Wish granted the most heartfelt wishes of more than 14,000 children throughout the United States and its territories. David Williams is raising the bar at this organization, which has the bold vision to grant every eligible child’s wish. “We are always humbled this time of year when we bring together advocates and scientists who are leading efforts in the fight against rare disease,” said Nicole Boice, CEO of Global Genes, “There is always more work to be done, but this event gives us the opportunity to honor and recognize those who are innovating, inspiring and teaching all of us what it really means to be a Champion.” Global Genes will also be hosting the Third Annual RARE Patient Advocacy Summit™ in conjunction with the Tribute to Champions of Hope Gala, September 11-12, 2014, which raises funds and awareness for rare diseases. The purpose of the RARE Patient Advocacy Summit is to help patient advocates become successful activists and provide the discussion, insights, and tools to move down this advocacy path, equipped and prepared. Some of this year’s partners include FasterCures, Health 2.0, Caregiver Action Network and Smart Patients. This event will also be available to view via Livestream, in real-time, for those who cannot attend in person. To date, sponsors of the 2014 Tribute to Champions of Hope Gala and RARE Patient Advocacy Summit include the following organizations: Walgreens, Alexion, Pfizer, Shire, Genzyme, Vidara, BIO, AstraZeneca, Raptor, Recordati Rare Diseases, Amicus Therapeutics, Jazz Pharmaceuticals, Sigma-Tau Pharmaceuticals and Sarepta Therapeutics. To learn more, register for these events, or for sponsorship opportunities, please visit .globalgenes.org/events About Global Genes – Allies in Rare Disease Global Genes™ is a leading rare disease patient advocacy organization. The group’s mission is to eliminate the challenges of rare disease, by providing patients with educational tools, building awareness, providing critical connections to people and resources, and through investment in technologies that will positively impact affected patients and families. Recognized worldwide by the Blue Denim Genes Ribbon™, Global Genes unites experts, advocates and patients of all ages to stand together in hope for treatments and cures for the estimated 7,000 rare and genetic diseases that impact approximately 30 million Americans and over 350 million people worldwide.

CORRECTING and REPLACING 2014 Next-Generation Pharmacistв„ў Finalists Announced

CORRECTING and REPLACING 2014 Next-Generation Pharmacistв„ў Finalists Announced

DURHAM, N.C.--(BUSINESS WIRE)--Under Military Pharmacist and Rising Star sections, Capt. Rohin N. Kasudia’s designation should be: BSC (instead of BCS). The corrected release reads: 2014 NEXT-GENERATION PHARMACIST™ FINALISTS ANNOUNCED Fifth Annual Event Recognizes Leaders, Encourages Excellence in Pharmacy Parata Systems and Pharmacy Times are pleased to announce the finalists for the 2014 Next-Generation Pharmacist™ awards. In its fifth year, the Next-Generation Pharmacist awards recognize pharmacy leaders across a wide range of practice settings, and this year the program attracted more than 500 entries. Finalists and winners in each category will be recognized at the Aug. About Lioresal (Baclofen) with no Rx 24 Innovation and Inspiration gala event in Boston where healthy aging pioneer, Dr. Buy Lipitor (Atorvastatin) James F. About Lamisil Cream (Terbinafine) with no prescription Fries of Stanford University School of Medicine, will celebrate and encourage the gathering with his keynote address, Pharmacists Helping Patients Live Well. The celebration of pharmacy innovators continues Aug. Buspirone without Rx 25 when Next-Generation Pharmacist convenes health care thought leaders for an industry insights roundtable, Helping Patients Live Better: Pharmacists in a Value-Driven Health Care System. Buy Garcinia Cambogia online The invitation-only conversation will focus on how pharmacists are helping to improve patient outcomes and lower health care costs in the age of accountable care and the evolving health care landscape. “Over five years, the Next-Generation Pharmacist program has grown a community of 150 finalists and hundreds of nominees recognized by their peers as the top pharmacists who are touching the lives of patients and caregivers daily,” said Tom Rhoads, CEO, Parata. http://medicalquestionanswers.wordpress.com “A conversation among these innovators in patient care promises to inspire all of us.” Established through a partnership of Parata Systems and Pharmacy Times, Next-Generation Pharmacist is pharmacy’s premier recognition program that honors and inspires pharmacists, technicians, student pharmacists and industry advocates who are defining the future of the industry. Next-Generation Pharmacist 2014 nominations were received across 10 award categories, and an independent panel of esteemed judges, chaired by Pharmacy Times Editor-in-Chief, Fred M. Eckel, RPh, MS, ScD (Hon), reviewed all entries. Three finalists are selected in each category, and these pharmacists, technicians and student pharmacists will be recognized at the 2014 awards gala. These finalists represent a true cross section of the industry, from large chain retailers, independent pharmacies, specialty pharmacies, military bases, health clinics and educational institutions. The 2014 finalists are: Civic Leader: Chris Geronsin, RPh, Beverly Hills Pharmacy and Gateway Apothecary, St. Louis, Mo. Amy Gutierrez, PharmD, Los Angeles County Department of Health Services, Los Angeles, Calif. Danny R. Johnson, RPh, Marble City Pharmacy, Sylacauga, Ala. Entrepreneur: Barry S. Bryant, RPh, CDM, CFTs, Barney’s Pharmacy, Augusta, Ga. Chris Geronsin, RPh, Beverly Hills Pharmacy and Gateway Apothecary, St. Louis, Mo. Bretton C. Walberg, RPh, Walberg Family Pharmacies, Jamestown, Pa. Future Pharmacist: Saswat Kabisatpathy, PharmD, South Carolina College of Pharmacy, Medical University of South Carolina, Charleston, S.C. Megan E. Saunders, PharmD, University of Wyoming School of Pharmacy, Laramie, Wyo. Laura Vollmer, PharmD Candidate 2015, Drake University College of Pharmacy and Health Sciences, Des Moines, Iowa Lifetime Leadership: Michel Disco, BSPharm, RPh, MBA, University of New Mexico College of Pharmacy, Albuquerque, N.M. Albert Garcia, BSPharm, RPh, MHL, Navarro Discount Pharmacy and Navarro Health Services, Medley, FL. Col. Keith A. Wagner, PharmD, RPh, U.S. Army, Dwight David Eisenhower Army Medical Center, Fort Gordon, Ga. Military Pharmacist: Lt. Cmdr. Vince Deguzman, PharmD, MBA, MSC, FACHE, U.S. Navy, Naval Hospital Lemoore Pharmacy, Lemoore, Calif. Capt. Rohin N. Kasudia, PharmD, BCACP, BSC, U.S. Air Force, 6th Medical Group, MacDill AFB, Fla. Col. Keith Wagner, PharmD, RPh, U.S. Army, Dwight David Eisenhower Army Medical Center, Fort Gordon, Ga. Patient Care Provider: Andrew Dum, RPh, FAPhA, Ahold USA, Inc., Carlisle, Pa. Jennifer Feig, PharmD, Duane Reade, New York Julienne Tran, PharmD, Ahold USA, Inc., Quincy, Mass. Rising Star: Michael N. Crowe, PharmD, MBA, CSP, FMPA, Diplomat Specialty Pharmacy, Flint, Mich. Capt. Rohin N. Kasudia, PharmD, BCACP, BSC, U.S. Air Force, 6th Medical Group, MacDill AFB, Fla. Samuel Stolpe, PharmD, Pharmacy Quality Alliance, Inc., Springfield, Va. Specialty Pharmacist: Michael N. Crowe, PharmD, MBA, CSP, FMPA, Diplomat Specialty Pharmacy, Flint, Mich. Greg Fox, RPh, Altius Heathcare/Fox Infusion, Tucson, Ariz. Jennifer Powers, PharmD, Walgreens, Lawrenceville, Ga. Technician: Colleen Jenkins, CPhT, St. Luke’s Health System, Boise, Idaho Mary Jane Magno, CPhT, Naval Hospital Lemoore Pharmacy, Lemoore, Calif. Brenton Michales, CPhT, CVS Pharmacy, Cortland, N.Y. Technology Innovator: Stephen F. Eckel, PharmD, MHA, BCPS, FASHP, FAPhA, FCCP, UNC Eshelman School of Pharmacy and UNC Hospitals Department of Pharmacy, Chapel Hill, N.C. Chris Geronsin, RPh, Beverly Hills Pharmacy and Gateway Apothecary, St. Louis, Mo. Jannette Soto, PharmD, Farmacia Del Pozo, Manati, Puerto Rico “The judges had a strong, diverse group of pharmacists to choose from,” said Ashley Hennessy Talamo, publisher, Pharmacy Times. “Each year the bar rises, and each year we are continually impressed with the candidates who are nominated. Every finalist represents the best and brightest of each category, and they are all making a difference in their fields.” “The tenacity and passion that each of these pharmacists brings to their roles within the larger health care system is inspiring,” said Rhoads. “They represent the epitome of excellence and leadership in the pharmaceutical industry. We are proud to have them represent the Next-Generation Pharmacist program and look forward to honoring each finalist as we recognize the category winners.” Each finalist will be profiled in the July 2014 issue of Pharmacy Times and on .pharmacytimes.com/. The winner for each category will be announced at the 2014 Next-Generation Pharmacist awards event Aug. 24 at The Fairmont Copley Plaza Hotel in Boston. Fries, this year’s keynote speaker, is a professor of medicine, immunology and rheumatology at Stanford University School of Medicine and author of more than 300 articles, numerous book chapters and 11 books, including “Take Care of Yourself” and “Living Well.” The Next-Generation Pharmacist industry insights roundtable will be held Monday, Aug. 25, and is entitled Helping Patients Live Better: Pharmacists in a Value-Driven Health Care System. Rhoads and Eckel will host and moderate the discussion. Panelists include Troy Trygstadt, PharmD, PhD, vice president, Pharmacy Programs, Community Care of North Carolina and guest editor, Directions in Pharmacy, a Pharmacy Times publication; Laura Cranston, RPh, executive director, Pharmacy Quality Alliance, Inc.; James F. Fries, MD, Stanford University School of Medicine; and Thomas E. Hubbard, vice president for policy research, Network for Excellence in Health Innovation. More information can be found at .nextgenerationpharmacist.com and .pharmacytimes.com. Sponsorship opportunities are also available and can be found at .nextgenerationpharmacist.com/sponsors. For regular updates, follow Next-Generation Pharmacist on Twitter and Facebook. About Parata Systems, LLC Parata provides technology solutions to support coordinated care, better health outcomes and lower medical costs, empowering pharmacists to grow their businesses. Founded in 2001, the Durham-based company is a brand trusted by more than 12,000 pharmacies and a growing number of global health care professionals serving diverse patient populations. Through Parata, pharmacists can leverage a combination of high-tech tools and workflow to free time to counsel patients, identify and avoid medication interactions, encourage adherence and more. We have filled more than 2.5 billion prescriptions, helping pharmacists avoid an estimated 15 million medication errors. For more information, visit .parata.com or contact info@parata.com or 888-PARATA1 (727-2821). About Pharmacy Times Pharmacy Times is the industry’s leading publication, providing practical clinical information pharmacists can use in their everyday practices when counseling patients and interacting with physicians. Each issue contains articles and features covering medication errors, drug interactions, patient education, pharmacy technology, disease state management, patient counseling, product news, pharmacy law and specialty pharmacy. The Pharmacy Times Office of Continuing Professional Education (CPE) is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Learn more at .PharmacyTimes.com, write to editorial@pharmacytimes.com, call 609-716-7777 or visit us on Facebook and on Twitter. Pharmacy Times is published by Michael J. Hennessy Associates, Inc., a leading provider of health care publishing, research, information and education. Next-Generation PharmacistTM is a trademark of Parata Systems, LLC.

The Medicines Company riceve il rinnovo dell'autorizzazione all'immissione in commercio di AngioxВ® (Bivalirudin) dall'Agenzia europea per i medicinali e dalla Commissione europea

The Medicines Company riceve il rinnovo dell'autorizzazione all'immissione in commercio di AngioxВ® (Bivalirudin) dall'Agenzia europea per i medicinali e dalla Commissione europea

PARSIPPANY, New Jersey--(BUSINESS WIRE)--The Medicines Company (NASDAQ:MDCO) ha annunciato in data odierna che l Agenzia europea per i medicinali (EMA), il Comitato per i medicinali per uso umano (CHMP) e la Commissione europea hanno approvato il rinnovo all immissione in commercio di Angiox® (Bivalirudin) – dopo aver passato in rassegna gli ultimi dati sugli studi clinici, la sicurezza e l efficia relativi al farmaco, nonché il piano di gestione dei rischi di Angiox. La raccomandazione del CHMP per il rinnovo dell autorizzazione all immissione in commercio di Angiox riconferma il rapporto rischio/beneficio favorevole del farmaco. Angiomax è un inibitore diretto della trombina e, in Europa, è indicato come anticoagulante per pazienti adulti sottoposti ad angioplastica (detta anche PCI), inclusi pazienti con infarto miocardico con sopraslivellamento ST (STEMI) sottoposti a PCI primario. In Europa, Angiox è anche indicato per il trattamento di pazienti adulti con angina instabile/infarto miocardico senza sopraslivellamento ST (UA/NSTEMI), destinati a un intervento urgente o precoce. Il rinnovo è applicabile ad Angiox in tutti gli stati membri dell Unione Europea/ Area Economica Europea. Nelle linee guida della Società europea di cardiologia (a cui si ispira il processo decisionale nel settore clinico), Angiox dispone di una raccomandazione favorevole nella classe 1B per uso in pazienti STEMI e NSTEMI sottoposti a PCI primario. In oltre 20 anni di studi clinici, Bivalirudin ha dimostrato un efficacia paragonabile (ed emorragie ridotte) rispetto all eparina in pazienti sottoposti a PCI, con o senza l inibitore della glicoproteina IIb/IIIa (GPI). Clozaril (Clozapine) with no Rx Bivalirudin è stato studiato in tredici studi clinici multicentro e in uno studio clinico randomizzato monocentrico, su un totale di oltre 35.000 pazienti – a supporto dell uso di Bivalirudin in presenza di PCI indipendentemente dall accesso femorale o radiale e dal tipo di inibitore del P2Y12. Buy Colcrys (Colchicine) with free Rx È stato dimostrato che in pazienti STEMI, Bivalirudin ha ridotto il tasso di mortalità fino a 3 anni, indipendentemente dallo stato emorragico. About Claritin (Loratadine) without Rx Tali risultati sono stati corroborati da vasti registri osservativi con dati reali, che hanno raccolto informazioni da circa 500.000. Buy Avalide with free Rx pazienti. ”Il rinnovo emesso dall EMA e dal CHMP sottolinea il valore clinico e l importantza di Angiox nella moderna cardiologia d intervento", ha commentato Simona Skerjanec, Pharm.D., vicepresidente senior e leader della divisione Acute Cardiovascular Care Global Innovation Group presso The Medicines Company. Buy Cranberry Tea online “Angiox continua a essere un opzione antitrombina critica per i cardiologi interventisti di tutto il mondo, i quali vi si affidano in fase terapeutica nel laboratorio di emodinamica e nel contesto di PCI. http://futurepharmaceuticals.wordpress.com È stato dimostrato che Angiox riporta simili esiti ischemici e minori complicazioni emmoragiche rispetto alle cure standard, nonché una ridotta mortalità nell Horizons AMI. I benefici del farmaco sono in linea con la nostra missione volta a salvare vite, alleviare la sofferenza e migliorare l economia dei servizi sanitari a livello globale”. Informazioni su Angiox/Angiomax In Europa, Angiox è attualmente indicato come anticoagulante per pazienti adulti sottoposti a PCI, inclusi i pazienti con infarto STEMI sottoposti a PCI primario. Angiox è anche indicato per il trattamento di pazienti adulti con angina instabile/infarto miocardico senza sopraslivellamento ST, destinati a un intervento urgente o precoce. Si prega di consultare le informazioni complete sulla sua prescrizione del farmaco disponibili all indirizzo .angiox.com. Negli Stati Uniti, Bivalirudin viene commercializzato sotto il nome di Angiomax ed è indicato nei pazienti sottoposti ad angioplastica (detta anche PCI) e nei pazienti con o a rischio di trombocitopenia indotta da eparina e sindrome di trombosi (HIT / HITTS) sottoposti a PCI. Inoltre, Angiomax è indicato per l uso come anticoagulante in pazienti con UA sottoposti ad angioplastica coronarica percutanea transluminale (PTCA). Angiomax va assunto con aspirina. Angiomax non è approvato per l uso in pazienti ACS non sottoposti a PCI o PTCA. La reazione avversa più comune di Angiomax negli studi clinici di confronto tra Angiomax ed eparina è stata l emorragia (28%). Tra le altre reazioni avverse comuni rientrano mal di testa, trombocitopenia e febbre. Un inspiegabile calo della pressione sanguigna o dell ematocrito, o qualsiasi sintomo inspiegabile, dovrebbe far prendere seriamente in considerazione un evento emorragico e far cessare la somministrazione di Angiomax. Angiomax va somministrato con cautela in pazienti affetti da patologie associate con un maggiore rischio di emorragie. Nella brachiterapia gamma, è stato associato un maggiore rischio di formazione di trombi, inclusi casi con esiti fatali, con l uso di Angiomax. Angiomax è controindicato in pazienti affetti da emorragie primarie attive o da ipersensibilità verso Angiomax o i suoi componenti. Si prega di consultare le informazioni complete sulla sua prescrizione di Angiomax all indirizzo: .angiomax.com. Informazioni su The Medicines Company L obiettivo di The Medicines Company è quello di salvare vite, alleviare la sofferenza e contribuire all economia dei servizi sanitari, concentrando la propria attenzione su 3.000 ospedali in tutto il mondo specializzati in terapia intensiva e casi acuti. L azienda vuole essere un fornitore leader di soluzioni che rientrano in tre aree di interesse: trattamento per casi cardiovascolari acuti, chirugia e assistenza perioperatoria. The Medicines Company opera nelle seguenti regioni: Americhe, Europa, Medio Oriente, Asia-Pacifico. I suoi centri internazionali si trovano a Parsippany, in New Jersey (USA), e Zurigo. Le dichiarazioni contenute in questo comunicato stampa sulla Medicines Company che non sono puramente storiche, e tutte le altre affermazioni che non sono puramente storiche, possono essere considerate dichiarazioni previsionali ai sensi delle direttive Safe Harbor del Private Securities Litigation Reform Act del 1995. Senza limitare quanto sopra, le parole "crede", "anticipa", "pianifica" "prevede" ed espressioni analoghe hanno lo scopo di identificare le dichiarazioni previsionali. Queste dichiarazioni previsionali implicano rischi, noti e sconosciuti, e incertezze che potrebbero rendere i risultati effettivi della Società, i livelli di attività, le prestazioni o i conseguimenti sostanzialmente diversi da quelli espressi o impliciti in tali dichiarazioni previsionali. Fattori importanti che possono causare o contribuire a tali differenze includono l eventualità che medici, pazienti e altri legislatori chiave accettino i risultati degli studi clinici come i risultati sopra descritti,simili altri fattori indicati nei fattori di rischio specificati di volta in volta nelle relazioni periodiche della Società e nelle dichiarazioni formali depositate presso la Securities and Exchange Commission, tra cui, senza limitazione, i fattori di rischio dettagliati nel rapporto trimestrale della Società nel modulo 10-Q depositato il 9 novembre 2011, che sono incorporati per riferimento nel presente documento. La Società declina ogni obbligo di aggiornare queste dichiarazioni previsionali. Nota: Questo comunicato stampa è stato pubblicato negli Stati Uniti ed è inteso come riferimento per investitori e giornalisti statunitensi. Il testo originale del presente annuncio, redatto nella lingua di partenza, è la versione ufficiale che fa fede. Le traduzioni sono offerte unicamente per comodità del lettore e devono rinviare al testo in lingua originale, che è l unico giuridicamente valido.

Compugen Discloses Achievement of Milestone in Cancer Immunotherapy Collaboration with Bayer

Compugen Discloses Achievement of Milestone in Cancer Immunotherapy Collaboration with Bayer

TEL AVIV, Israel--(BUSINESS WIRE)--Compugen Ltd. (NASDAQ: CGEN) disclosed today that it has achieved the initial milestone in the cancer immunotherapy collaboration it entered last year with Bayer HealthCare (Bayer). The collaboration provides for the development and commercialization of therapeutic antibodies against two checkpoint protein candidates discovered by Compugen. The milestone being announced today relates to the first preclinical milestone for one of two checkpoint protein candidates for which Compugen will receive a $1.2 million payment out of the $30 million potential milestone payments associated with joint preclinical research for the two programs. Dr. Clozaril (Clozapine) with no Rx Anat Cohen Dayag, Compugen’s President and CEO, stated, “We are very pleased by the achievement of this initial drug development milestone for one of the two programs in our collaboration with Bayer. Buy Colcrys (Colchicine) with free Rx After investing more than a decade of extensive multidisciplinary research in establishing our broadly applicable predictive discovery infrastructure, we selected the area of checkpoint-based cancer immunotherapy as our first focused discovery effort. About Claritin (Loratadine) without Rx Therefore, it is extremely satisfying to see our growing competitive position, in terms of both advancement of our therapeutic programs in immuno-oncology and continuing discoveries of novel targets in this exciting area, which is increasingly being viewed as a potential major breakthrough in cancer treatment.” About the Bayer HealthCare/Compugen Collaboration and License Agreement The collaboration and license agreement provides the framework for the research, development, and commercialization of antibody-based therapeutics for cancer immunotherapy against two novel Compugen-discovered immune checkpoint regulators. Under the terms of the agreement, Bayer and Compugen are jointly pursuing a preclinical research program for each of the two candidates. Buy Avalide with free Rx Subsequently, Bayer will have full control over further development and have worldwide commercialization rights for potential cancer therapeutics. Under the terms of the agreement, Compugen has received an upfront payment of $10 million and is eligible to receive over $500 million in potential milestone payments for both checkpoint programs, plus an additional $30 million of potential milestone payments associated with joint preclinical research for the two programs. Compugen is also eligible to receive royalties on global net sales from any resulting products under the collaboration. About Cancer Immunotherapy Latest cancer immunotherapies have demonstrated impressive clinical benefit, even for end-stage patients with difficult-to-treat tumors such as metastatic melanoma and non-small cell lung cancer. Buy Cranberry Tea online Unlike conventional cancer therapies, which act by directly targeting the cancer cells, often resulting in only transient clinical responses as cancer cells become resistant, clinical responses to cancer immunotherapy tend to be durable, sometimes resulting in dramatic long-term survival and the absence of resistance or recurrences. About Compugen Compugen is a leading drug discovery company focused on therapeutic proteins and monoclonal antibodies to address important unmet needs in the fields of immunology and oncology. The Company utilizes a broad and continuously growing integrated infrastructure of proprietary scientific understandings and predictive platforms, algorithms, machine learning systems and other computational biology capabilities for the in silico (by computer) prediction and selection of product candidates, which are then advanced in its Pipeline Program. http://futurepharmaceuticals.wordpress.com The Company s business model includes collaborations covering the further development and commercialization of product candidates at various stages from its Pipeline Program and various forms of research and discovery agreements, in both cases providing Compugen with potential milestone payments and royalties on product sales or other forms of revenue sharing. Compugen’s wholly-owned U.S. subsidiary located in South San Francisco is developing oncology and immunology monoclonal antibody therapeutic candidates against its drug targets. For additional information, please visit Compugen s corporate website at .cgen.com. This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the potential for development and commercialization of therapeutic products pursuant to the Bayer Collaboration. Forward-looking statements can be identified by the use of terminology such as “will,” “may,” “expects,” “potential,” “anticipates,” “believes” and “intends,” and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the inability to reach mutually agreeable terms and conditions with respect to potential new collaborations; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are discussed in the "Risk Factors" section of Compugen’s most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission as well as other documents that may be subsequently filed by Compugen from time to time with the Securities and Exchange Commission. In addition, any forward-looking statements represent Compugen’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law.

Roche Seragon buy

. http://futurepharmaceuticals.wordpress.com Buy Black Cohosh online Aldactazide with free Rx Cialis Daily (Tadalafil) with no prescription Ciloxan (Ciprofloxacin) with no prescription About Cialis Super Active (Tadalafil) without prescription che offshoot Genentech has announced the US$1.7 billion acquisition of Seragon Pharmaceuticals, with the move said to boost Roche’s pipeline of potential cancer treatments. Seragon has a portfolio of experimental Oral Selective Oestrogen Receptor Degraders (SERDs) which target the treatment of hormone receptor-positive breast cancer. Genentech will pay an initial $725m in cash plus further milestone payments of up to $1b. Seragon was founded last year as a spin-off of Aragon Pharmaceuticals.