DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/p8l4hh/global_colorectal) has announced the addition of the "Global Colorectal Cancer Drugs Market 2015-2019" report to their offering. The global colorectal cancer drugs market to grow at a CAGR of 3.62% over the period 2014-2019. Biologics are rapidly becoming the treatment of choice for colorectal cancer. Buy Mobic (Meloxicam) without Rx Biologics are targeted therapy, which act only on the malignant cells and do not attack the healthy cells. Buy Levaquin (Levofloxacin) with free prescription The major biologics used for treating colorectal cancer include Erbitux (cetuximab), Zaltrap (ziv-Aflibercept), Avastin (bevacizumab), and Vectibix (panitumumab). About Female Viagra (Sildenafil Citrate) with free prescription These biologics together accounted for the major share of the market, and the same trend is expected to continue during the forecast period. According to the report, colorectal cancers cannot be cured by the currently available therapeutic options. About Ditropan In addition, if it has not metastasized, surgery would be the only option. About Thorazine (Chlorpromazine) without Rx The chances of cancer recurring near the place of origin are high. Buy Vitamin B2 - Riboflavin online The currently available branded and generic drugs are indicated only for off-label treatment use. http://medical-reviews.blogspot.com However, these drugs have many side effects. Hyperbilirubinemia, gastrointestinal perforation, coagulopathy, cardiotoxicity, hemorrhage, hepatotoxicity, neutropenia, proteinuria, thrombocytopenia, ischemia, soft tissue toxicity, pulmonary fibrosis, and increased mortality are some of the significant adverse side effects. Thus, a drug maker has opportunities to exploit and seek a favorable position in the market by addressing these issues. Further, the report states that many branded drugs available in the market have lost their patents or are expected to lose it during the forecast period. This report covers the present scenario and the growth prospects of the global colorectal cancer drugs market for the period 2015-2019. To calculate the market size, the report considers revenue generated from sales of various drugs used in the treatment of colorectal cancer. Based on the type of molecule, the market is grouped into two categories: - Biologics - Small molecules Based on the route of administration, the market is grouped into two categories: - Oral - Parenteral Key Vendors - Amgen - Bayer - Bristol-Myers Squibb - F. Hoffmann-La Roche - Merck Serono Other Prominent Vendors - Accord Healthcare - Advenchen Laboratories - Aeterna Zentaris - AstraZeneca - Bavarian Nordic - Biothera - Boehringer Ingelheim - Daiichi Sankyo - Debiopharm - Eisai - Eli Lilly - Immodulon Therapeutics - Mologen - Mylan - Nektar Therapeutics - Oncothyreon - Otsuka Pharmaceutical - Precision Biologics - Sun Pharmaceutical - Symphogen - Taiho - Takeda - Teva - ThromboGenics - Xbiotech - Yakult Honsha For more information visit .researchandmarkets.com/research/p8l4hh/global_colorectal

Takeda pr'esente un dossier d'autorisation de mise sur le march'e pour l'ixazomib en vue du traitement des patients atteints de my'elome multiple r'ecurrent ou r'efractaire aux m'edicaments

CAMBRIDGE, Massachusetts et OSAKA, Japon--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (Bourse de Tokyo : 4502) a annonc e aujourd hui qu elle avait pr esent e `a la Food and Drug Administration (FDA) des Etats-Unis un dossier d autorisation de mise sur le march e pour l ixazomib, un inhibiteur oral exp erimental du prot easome, en vue du traitement des patients atteints de my elome multiple r ecurrent ou r efractaire aux m edicaments. Le dossier d autorisation de mise sur le march e se fonde sur l etude clinique de phase III TOURMALINE-MM1, un essai clinique international, randomis e, `a double insu, contr^ol e par placebo, men e aupr`es de 722 patients dans le but d evaluer la sup eriorit e de l ixazomib en association avec le l enalidomide et la dexam ethasone sur un placebo en association avec le l enalidomide et la dexam ethasone chez des patients adultes atteints de my elome multiple r ecurrent et/ou r efractaire. About Indocin Sr (Indomethacin) without Rx Durant l essai clinique, les patients poursuivent leur traitement et les r esultats `a long terme sont evalu es. « L etude TOURMALINE-MM1 est la premi`ere d une s erie de cinq essais cliniques de phase III faisant partie de notre programme sur l ixazomib, lequel a pour but d evaluer si un traitement prolong e par un inhibiteur du prot easome, par voie orale, am eliore les r esultats cliniques des patients atteints de my elome multiple ou d amylose A, a d eclar e Andrew Plump, M.D., Ph. About Nizoral Cream (Ketoconazole) with free prescription D., m edecin-chef et conseiller scientifique en chef de Takeda. About Viagra Soft (Sildenafil Citrate) with free Rx Cette pr esentation t emoigne de l engagement continu de Takeda `a innover au service des patients atteints de my elome multiple. About Detrol with free prescription Nous remercions les patients et leur famille de la confiance qu ils accordent `a Takeda et `a l ixazomib en participant au programme TOURMALINE. Vitamin B12 (Methylcobalamin) with no Rx » « La continuit e du traitement chez les patients atteints de my elome multiple est maintenant accept ee comme norme de traitement etant donn e l am elioration des r esultats `a long terme, a fait remarqu e Paul Richardson, M.D., directeur du programme clinique et directeur de la recherche, Jerome Lipper Multiple Myeloma Center, m edecin au Dana-Farber Cancer Institute. Buy Stevia online L inhibition du prot easome est devenue une composante essentielle du traitement, mais les approches intraveineuses et sous-cutan ees posent des probl`emes d ordre logistique aux patients, en particulier en l absence d option orale efficace. http://webmdhelper.wordpress.com S il est approuv e, l ixazomib devrait repr esenter une avanc ee significative pour nos patients, etant donn e son efficacit e et la commodit e d une administration orale hebdomadaire. » Il s agit de la premi`ere pr esentation r eglementaire concernant l ixazomib. D autres dossiers seront d epos es en Europe et dans d autres pays plus tard cette ann ee. `A propos du my elome multipleLe my elome multiple est un cancer du sang qui se d eclare dans la moelle osseuse. La maladie se caract erise par la prolif eration de cellules plasmatiques anormales. Parce les cellules plasmatiques circulent largement dans le corps, elles peuvent affecter de nombreux os et entra^iner des fractures par tassement, des l esions osseuses lytiques et de la douleur. Le my elome multiple peut entra^iner nombre de graves probl`emes de sant e touchant les os, le syst`eme immunitaire, les reins et le nombre de globules rouges dans le sang, les sympt^omes les plus courants etant notamment des douleurs aux os et de la fatigue, un signe d an emie. Le my elome multiple est une forme de cancer relativement rare. Chaque ann ee, environ 20 000 nouveaux cas sont d eclar es aux Etats-Unis et il y a 114 000 nouveaux cas `a l echelle mondiale. `A propos de l ixazomibL’ixazomib (MLN9708) est un inhibiteur oral exp erimental du prot easome `a l etude dans le traitement du my elome multiple, de l’amylose AL et d autres affections malignes. L’ixazomib a recu la d esignation de m edicament orphelin pour le my elome multiple aux Etats-Unis et en Europe en 2011, et pour l’amylose AL aux Etats-Unis et en Europe en 2012. En 2014, la Food and Drug Administration (FDA) des Etats-Unis a accord e `a l’ixazomib la d esignation « th erapie r evolutionnaire » pour les patients atteints d amylose AL r ecurrente ou r efractaire. Il s’agit egalement du premier inhibiteur oral du prot easome `a faire l objet d essais cliniques de phase III. Le programme de d eveloppement clinique de l ixazomib souligne l engagement constant de Takeda `a mettre au point des m edicaments novateurs au profit des personnes souffrant de my elome multiple dans le monde entier et des professionnels de la sant e qui participent `a leur traitement. Cinq essais mondiaux de phase III sont en cours : TOURMALINE-MM1, qui etudie l’ixazomib comparativement au placebo en association avec le l enalidomide et la dexam ethasone pour le my elome multiple r ecurrent et/ou r efractaire TOURMALINE-MM2, qui etudie l’ixazomib comparativement au placebo en association avec le l enalidomide et la dexam ethasone chez des patients atteints d un my elome multiple nouvellement diagnostiqu e TOURMALINE-MM3, qui etudie l’ixazomib comparativement au placebo comme traitement d entretien chez des patients atteints d un my elome multiple nouvellement diagnostiqu e apr`es un premier traitement et une greffe de cellules souches autologue TOURMALINE-MM4, qui etudie l’ixazomib comparativement au placebo comme traitement d entretien chez des patients atteints d un my elome multiple nouvellement diagnostiqu e qui n ont pas subi de greffe de cellules souches autologue TOURMALINE-AL1, qui etudie l’ixazomib en association avec la dexam ethasone comparativement `a une s election de sch emas th erapeutiques au choix du m edecin chez des patients ayant une amylose AL r ecurrente ou r efractaire Pour en apprendre plus sur les etudes de phase III en cours, visitez le site .clinicaltrials.gov. `A propos de Takeda OncologyTakeda Oncology est une unit e commerciale d envergure mondiale de Millennium Pharmaceuticals inc., une filiale en propri et e exclusive de Takeda Pharmaceutical Company Limited. Takeda aspire `a gu erir le cancer en mettant au point de nouveaux m edicaments afin de r epondre aux besoins uniques et pressants des personnes atteintes d un cancer, de leurs proches et des fournisseurs de soins de sant e dans le monde entier. Takeda arrive au 11e rang mondial des soci et es pharmaceutiques sp ecialis ees en oncologie. Elle compte un portefeuille de m edicaments aptes `a modifier les paradigmes de traitement et plusieurs produits exp erimentaux qui ont le potentiel d am eliorer consid erablement les r esultats des patients atteints de diff erents cancers. En alliant le pouvoir de la recherche scientifique `a l esprit d entreprise et aux vastes ressources d une soci et e pharmaceutique mondiale, Takeda Oncology trouve des facons nouvelles et novatrices d am eliorer le traitement du cancer. Pour obtenir de plus amples renseignements sur Takeda Oncology, consultez son site Web `a l adresse .takedaoncology.com. `A propos de TakedaTakeda est une soci et e pharmaceutique d envergure mondiale ax ee sur la recherche. Son si`ege social est situ e `a Osaka, au Japon. La plus grande soci et e pharmaceutique au Japon et un des leaders mondiaux dans son secteur, Takeda concentre ses efforts sur l am elioration de la sant e des patients `a travers le monde au moyen d innovations m edicales de premier plan. Pour de plus amples renseignements sur Takeda, consultez le site Web de la soci et e `a l adresse .takeda.com. 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.

Celgene to Acquire Receptos, Advancing Leadership in Immune-Inflammatory Diseases

SUMMIT, N.J. Buy Glucophage Xr (Metformin) & SAN DIEGO--(BUSINESS WIRE)--Celgene Corporation (NASDAQ: CELG) and Receptos, Inc. About Patanol (Olopatadine Hcl) with free prescription (NASDAQ: RCPT) today announced the signing of a definitive agreement in which Celgene has agreed to acquire Receptos. Buy Kamagra (Sildenafil Citrate) with no Rx Under the terms of the merger agreement, Celgene will pay $232.00 per share in cash, or a total of approximately $7.2 billion, net of cash acquired. The acquisition of Receptos significantly enhances Celgene’s Inflammation & Immunology (I&I) portfolio, further diversifies the Company’s revenue beginning in 2019 and beyond, and builds upon Celgene’s growing expertise in inflammatory bowel disease (IBD). About Depreks with free Rx The transaction adds Ozanimod, a novel, potential best-in-class, oral, once-daily, selective sphingosine 1-phosphate 1 and 5 receptor modulator (S1P) to Celgene’s deep and diverse pipeline of potential disease-altering medicines and investigational compounds. Based on clinical studies, Ozanimod demonstrated several areas of potential advantage over existing oral therapies for the treatment of ulcerative colitis (UC) and relapsing multiple sclerosis (RMS), including its cardiac, hepatotoxicity and lymphocyte recovery profile. Xeloda (Capecitabine) without Rx The phase III TRUE NORTH trial in UC is currently underway with data expected in 2018. Buy Skin Care - Face online The phase III RADIANCE and SUNBEAM RMS trials are ongoing and data are expected in the first half of 2017 to support a RMS approval in 2018. http://medical-questions-answers.blogspot.com Additionally, Ozanimod is positioned to potentially become the first S1P receptor modulator to be approved for IBD. "The Receptos acquisition provides a transformational opportunity for Celgene to impact multiple therapeutic areas,” said Bob Hugin, Chairman and Chief Executive Officer of Celgene. “This acquisition enhances our I&I portfolio and allows us to leverage the investments made in our global organization to accelerate our growth in the medium and long-term.” Celgene has a strong scientific foundation in inflammation and immunology that covers a broad spectrum of diseases. Anchored by the successful global launch of OTEZLA® (apremilast) in psoriasis and psoriatic arthritis, and new opportunities for expansion as a result of the addition of the Receptos programs, Celgene’s I&I pipeline will, upon completion of the transaction, consist of three high-potential commercialized or late-stage assets; OTEZLA, GED-0301 and Ozanimod. All three candidates are in phase III development and encompass four indications: Behcet’s disease, Crohn’s disease (CD), UC and RMS. The pipeline also includes seven molecules in phase II development in a variety of indications, including RPC4046 for eosinophilic esophagitis (EoE), and a growing number of phase I and preclinical assets. Learn more about Celgene’s I&I pipeline here. “In Celgene, we have found the ideal partner to maximize the potential of Ozanimod and our promising pipeline in order to improve the lives of patients worldwide,” said Faheem Hasnain, President and Chief Executive Officer of Receptos. “Ozanimod is a potentially transformational oral therapy that has demonstrated robust clinical activity with impressive immune-inflammatory modulating properties in phase II trials,” said Scott Smith, President, I&I for Celgene. “Ozanimod is a highly differentiated next-generation S1P receptor modulator with important efficacy and safety features that create the opportunity for development across a spectrum of immune-inflammatory diseases.” Recent Receptos Clinical Data: Ulcerative Colitis Ozanimod phase II data were presented by Receptos at the Gastroenterology Conference Digestive Disease Week (DDW) in May 2015 in Washington, D.C. The TOUCHSTONE phase II study, evaluating Ozanimod in UC, met key clinical and endoscopic endpoints for both induction and maintenance with statistical significance in patients on the 1.0 mg dose of Ozanimod in the 8-week induction and 32-week maintenance periods. The overall safety and tolerability profile of Ozanimod was consistent with the results of the phase II trial in RMS. A phase III program, TRUE NORTH, in UC has initiated enrollment and a phase II program in CD is expected to initiate by year-end. Recent Receptos Clinical Data: Relapsing Multiple Sclerosis At the 2015 Annual Meeting of the American Academy of Neurology (AAN) in Washington, D.C., Receptos presented results of an Ozanimod phase II study in RMS. The study demonstrated that Ozanimod achieved the primary endpoint of reduction in MRI brain lesion activity as well as secondary endpoints measuring effects on other MRI parameters. The overall safety profile of Ozanimod was consistent with the results of prior trials and continues to demonstrate differentiation against other oral agents for the treatment of RMS. Two phase III clinical trials are underway: RADIANCE and SUNBEAM, both of which are randomized, controlled, double-blind studies designed to compare 0.5 mg and 1.0 mg of Ozanimod against interferon beta-1a (Avonex®) in patients with RMS. Terms of the Agreement Celgene will acquire all of the outstanding shares of common stock of Receptos through a tender offer, followed by a second-step merger. In the tender offer, Celgene, through a wholly-owned subsidiary, will offer to purchase all of the outstanding shares of common stock of Receptos for $232.00 per share in cash, or an aggregate of approximately $7.2 billion, net of cash acquired. The transaction has been approved by the boards of directors of both companies and is subject to customary closing conditions, including the tender of at least a majority of outstanding shares of Receptos common stock and expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The transaction is anticipated to close in 2015. Celgene will acquire all remaining shares of Receptos common stock that are not tendered in the tender offer through a second-step merger, which will be completed shortly following the tender offer. Celgene expects to fund the transaction through a combination of existing cash and new debt. The resulting capital structure is consistent with Celgene’s financial strategy and investment grade profile. This acquisition maintains flexibility for additional value creating transactions and share buyback. J.P. Morgan and Citi are acting as financial advisors to Celgene on the transaction. Centerview Partners LLC is acting as financial advisor to Receptos. Legal counsel for Celgene is Proskauer Rose LLP, and Receptos’ legal counsel is Latham & Watkins LLP. Preliminary Second Quarter 2015 Financial Highlights for Celgene Preliminary net product sales of $2,254 million for the second quarter of 2015 compared to $1,845 million in the second quarter of 2014, represents an increase of 22 percent. Second quarter total revenue also increased 22 percent to approximately $2,278 million compared to $1,873 million in the second quarter of 2014. For the same period, adjusted diluted EPS increased 37 percent to approximately $1.23 from $0.90. Adjusted diluted EPS for the second quarter of 2015 included a $0.06 per share gain related to the sale of an equity investment upon the completion of their acquisition by another company. Based on U.S. GAAP (Generally Accepted Accounting Principles), preliminary second quarter 2015 diluted EPS was approximately $0.43 per diluted share. For the second quarter of 2014, diluted EPS was $0.72 per diluted share. Second quarter 2015 GAAP EPS included increased expenses for upfront collaboration payments. 2015 Guidance for Celgene Reaffirming total net product sales to a range of $9 billion to $9.5 billion Raising adjusted diluted EPS to a range of $4.75 to $4.85 from the previous range of $4.60 to $4.75, an increase of approximately 29 percent over 2014 adjusted diluted EPS GAAP diluted EPS is expected to be in the range of $2.43 to $2.71 from the previous range of $2.97 to $3.19 2020 Long-term Financial Targets for Celgene Increasing 2020 net product sales to exceed $21 billion, up from the previous target of greater than $20 billion Hematology franchise expected to exceed $14.8 billion Oncology franchise expected to exceed $2.2 billion I&I franchise now expected to exceed $4.0 billion, up from the previous target of $3.0 billion Adjusted diluted EPS is expected to exceed $13.00, up from the previous target of $12.50 Fully diluted share count is expected to be approximately 830 million About Ozanimod Ozanimod is a selective immune-inflammatory modulator of the G protein-coupled receptors sphingosine 1-phosphate 1 and 5, which are part of the sphingosine 1-phosphate (S1P) receptor family. Treatment with S1P receptor modulators interferes with S1P signaling and blocks the response of lymphocytes (a type of white blood cell) to exit signals from the lymph nodes, sequestering them within the nodes. The result is a downward modulation of circulating lymphocytes and anti-inflammatory activity by inhibiting cell migration to sites of inflammation. About Receptos Receptos is a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases. Receptos lead program, Ozanimod, is a sphingosine 1-phosphate 1 and 5 receptor small molecule modulator in development for immune-inflammatory indications including IBD and RMS. Patents supporting Ozanimod were exclusively licensed to Receptos from The Scripps Research Institute (TSRI). Receptos is also developing RPC4046, an anti-interleukin-13 (IL-13) antibody for (EoE), an allergic/immune-mediated orphan disease, as well as other pipeline and pre-clinical stage compounds. About Celgene Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit .celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn and YouTube. Conference Call and Webcast Information Celgene will host a conference call today, July 14, to discuss the strategic acquisition of Receptos at 5:30 p.m. EDT. The conference call will be available by webcast on the Investor Relations page of Celgene’s website, .Celgene.com. An audio replay of the call will be available from midnight July 14, 2015 until midnight July 30, 2015. To access the replay in the U.S., dial (855) 859-2056; outside the U.S. dial (404) 537-3406. The participant passcode is 81657332. Additional Information about the Transaction and Where to Find It The tender offer described herein has not yet commenced. The description contained herein is for informational purposes only and is not an offer to buy or the solicitation of an offer to sell any shares of Receptos. At the time the tender offer is commenced, Celgene and its wholly-owned subsidiary, Strix Corporation, intend to file with the U.S. Securities and Exchange Commission (the “SEC”) a Tender Offer Statement on Schedule TO containing an offer to purchase, a form of letter of transmittal and other documents relating to the tender offer, and Receptos intends to file a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. Celgene, Strix Corporation and Receptos intend to mail these documents to the stockholders of Receptos. THESE DOCUMENTS, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, WILL CONTAIN IMPORTANT INFORMATION ABOUT THE TENDER OFFER AND RECEPTOS STOCKHOLDERS ARE URGED TO READ THEM CAREFULLY WHEN THEY BECOME AVAILABLE. Stockholders of Receptos will be able to obtain a free copy of these documents (when they become available) and other documents filed by Receptos, Celgene or Strix Corporation with the SEC at the website maintained by the SEC at .sec.gov. Forward-Looking Statements This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management s current plans, estimates, assumptions and projections, and speak only as of the date they are made. Celgene and Receptos undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond the control of either company, including the following: (a) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement; (b) the inability to complete the transaction due to the failure to satisfy conditions to the transaction; (c) the risk that the proposed transaction disrupts current plans and operations; (d) difficulties or unanticipated expenses in connection with integrating Receptos into Celgene; (e) the risk that the acquisition does not perform as planned; and (f) potential difficulties in employee retention following the closing of the transaction. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in the public reports of each company filed with the SEC. In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted financial measures that Celgene believes provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information. These adjusted financial measures are non-GAAP and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. Celgene typically excludes certain GAAP items that management does not believe affect its basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways. See the attached Reconciliation of Estimated/Projected GAAP to Adjusted (Non-GAAP) Diluted EPS for explanations of the amounts excluded and included to arrive at Celgene’s adjusted EPS amounts for the three month period ended June 30, 2015 and for the projected amounts for the year ending December 31, 2015. Celgene Corporation and Subsidiaries Reconciliation of Estimated/Projected GAAP to Adjusted (Non-GAAP) Diluted EPS (Unaudited)           Three Months Ended Twelve Months Ending June 30, 2015 December 31, 2015 Range Range Low High Low High Estimated/projected diluted earnings per common share - GAAP (1) $ 0.42 $ 0.44 $ 2.43 $ 2.71   Per share impact of excluded items before tax: Share-based compensation expense (2) 0.18 0.18 0.71 0.68 Upfront collaboration expense (1)(3) 0.69 0.69 1.40 1.29 Amortization of acquired intangible assets (1)(4) 0.08 0.08 0.31 0.31 Change in fair value of contingent consideration (1)(5) (0.03 ) (0.05 ) 0.07 0.05 Acquisition related charges (1)(6) - - 0.09 0.03 Net income tax adjustments (7)   (0.11 )     (0.11 )   (0.26 )   (0.22 ) Estimated/projected diluted earnings per common share - Adjusted Approximately $ 1.23 $ 4.75   $ 4.85     In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted financial measures that we believe provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information. These adjusted financial measures are non-GAAP and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We typically exclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways.   Explanation of adjustments: (1)   Our estimated/projected 2015 diluted EPS amounts do not include the effect of any business combinations, collaboration agreements, asset acquisitions, intangible asset impairments, or changes in the fair value of our CVRs issued as part of the acquisition of Abraxis BioScience Inc. (Abraxis) that may occur or be announced after this press release. (2) Exclude share-based compensation expense. (3) Exclude upfront payment expense for research and development collaboration arrangements. (4) Exclude amortization of intangible assets acquired in the acquisitions of Pharmion Corp., Gloucester Pharmaceuticals, Inc. (Gloucester), Abraxis and Celgene Avilomics Research, Inc. (Avila). (5) Exclude changes in the fair value of contingent consideration related to the acquisitions of Gloucester, Abraxis, Avila and Nogra Pharma Limited. (6) Exclude acquisition related charges related to the acquisition of Receptos, Inc. (7) Net income tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain other non-operating tax adjustments, including the effects of acquisition related matters, adjustments to the amount of unrecognized tax benefits, and an adjustment related to the gain on the sale of an equity investment.

Apexus Launches New Online Education Program Aimed to Improve 340B Compliance

IRVING, Texas--(BUSINESS WIRE)--Apexus, the nation’s leading source of information about the 340B Drug Pricing Program, has released a new online educational resource for the growing number of health care professionals working in the 340B field. About Cyklokapron (Tranexamic Acid) with free prescription The program’s content has been reviewed and certified by the U.S. Silagra (Sildenafil Citrate) with free Rx Health Resources and Services Administration (HRSA), as consistent with its interpretation of federal 340B policy. 340B University OnDemand™ modules provide 340B education for all stakeholders involved in the 340B Drug Pricing Program. About Penisole () with no prescription These online modules cover the foundational topics of the 340B program, including eligibility, registration, recertification, pricing, contract pharmacy, implementation models, and audit preparedness, among other topics. “There is a growing demand for information and education about the 340B program,” said Chris Hatwig, MS, RPh, FASHP, the president of Apexus. About Cyproheptadine with no prescription “Every year we see more than 2,500 people attend our live 340B University programs around the country. Antivert (Meclizine) without prescription Our new online program will expand the reach of these efforts and help improve program compliance and integrity.” The 340B University OnDemand e-learning modules can be accessed online and is offered by Apexus at no charge. Buy Prostate Supplements online Self-directed modules are authored by subject matter experts, are convenient, and come from a trusted source. http://webmdmagazine.wordpress.com The coursework will help all stakeholders better understand how 340B can help expand access to needed treatment by shoring up the resources of institutions that provide access and treatment to patients who are uninsured or underinsured. Apexus serves as the exclusive prime vendor for the 340B Drug Pricing Program, managed by the Health Resources and Services Administration (HRSA). As the 340B prime vendor, Apexus works closely with HRSA s Office of Pharmacy Affairs to enable approved entities to optimize the value of the 340B drug pricing by both reducing costs and supporting entities to establish compliant operations in the communities they serve. Apexus also operates Apexus Answers, the national call center available for all stakeholder questions, and manages in-depth 340B educational programs through 340B University™ to support stakeholder compliance and program integrity. Based in Irving, Texas, Apexus currently serves more than 25,000 safety-net provider locations by delivering additional savings on pharmaceuticals through the 340B Prime Vendor Program (PVP).

. Buy Prostate Supplements online Watchful waiting in the management of localized low-risk prostate cancer has risen sharply as "overtreatment" has fallen, suggesting an improvement in the management of the disease, according to a report in JAMA. There has been more watchful waiting instead of aggressive treatment such as surgery. In the analysis of 10,472 men from 1990 to 2013, use of surveillance for low-risk disease rose sharply in 2010 through 2013, to 40% of cases. http://webmdmagazine.wordpress.com About Cyklokapron (Tranexamic Acid) with free prescription Use of surveillance had previously remained low, at between 7% and 14%, from 1990 through 2009. Dr. Silagra (Sildenafil Citrate) with free Rx Matthew Cooperberg did the study with Dr. About Penisole () with no prescription Peter Carroll, both of the University of California, San Francisco, to analyze recent trends in community-based patterns of managing localized prostate cancer. Data from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) were used. About Cyproheptadine with no prescription This is a national registry of men with prostate cancer cared for since 1995 across 45 US urology practices. The study included men with tumors classified as stage cT3aNoMo or lower managed with prostatectomy, radiation, androgen deprivation monotherapy, or active surveillance/watchful waiting between 1990 and 2013. While watchful waiting rose, rates of treatment with androgen deprivation for intermediate-risk and high-risk tumors fell. This form of management had been rising steadily from 1990 (10% and 30% for intermediate- and high-risk respectively), but fell sharply from 2010 (to 4% and 24%, respectively). The rise in opting for surveillance also happened among men of 75 years of age or older, although after a dip. Antivert (Meclizine) without prescription This rate was 54% from 1990 through 1994, 22% from 2000 through 2004, and 76% from 2010 through 2013. There was an increase in the use of surgery for men aged 75 years or older with low-risk cancer, to 9.5%, and intermediate-risk cancer, to 15%. There was no increase in opting for surgery, however, for those with high-risk cancer, among whom androgen deprivation still accounted for 67% of treatment. Arguments against population screening now less strong The authors believe the trends may result in changes to approaches for the cancer mostly affecting older men: "Given that overtreatment of low-risk disease is a major driver of arguments against prostate cancer screening efforts, these observations may help inform a renewed discussion regarding early detection policy in the United States." They add: "The magnitude and speed of the changes suggest a genuine change in the management of patients with prostate cancer in the United States, which could accelerate as more clinicians begin to participate in registry efforts." Written by Markus MacGill

Two studies published in PLOS Pathogens this month shed further light on the effect of neutralizing antibodies in the steep challenge facing researchers to develop a vaccine against AIDS/HIV. Buy Aristocort (Triamcinolone) with no prescription Nabs are immune proteins that can recognize, bind to, and trigger the elimination of a virus. Buy Vibramycin (Doxycycline) Image credit: Dr. Buy Feldene (Piroxicam) Alexandra Trkola The search for an effective vaccine for AIDS/HIV has long been a battle for scientists and researchers around the world. Co-trimoxazole Although HIV incidence have remained stable around the world at 50,000 new infections per year, a cure still remains to be found. Neutralizing antibodies are immune proteins that can recognize, bind to, and trigger the elimination of a virus before it can establish a chronic infection. Cialis Daily (Tadalafil) with free prescription Nabs have previously been researched as a tool against HIV and AIDs. Buy Nasal online In a study last year, scientists discovered for the first time how to create Nabs in those already infected with HIV-1. http://webmdconsult.wordpress.com Dr. Julia Overbaugh, from the Fred Hutchinson Cancer Research Center in Seattle, WA, and her team, focused on the role of Nabs in those "superinfected" with HIV, which is defined as those sequentially infected at least twice with HIV by different sexual partners. Results from 21 women who were tested suggest that Nabs mount a broad and potent response against diverse HIV subtypes. It is hoped that that this particular response can be mediated at least in part by polyclonal antibodies, which can then target different aspects of the virus. These findings follow on from the team s previous research into the superinfected. In that study, it was discovered that those infected twice had a more potent antibody response to the virus - which inhibited the virus from replicating - compared with women who have only been infected once. Dr. Overbaugh hopes further research can be done on those superinfected, stating further research may "provide insight to the development of a diverse Nab response with multiple epitope specificities." Direct cell to cell transmission more prone to mutation strains The second study published in PLOS Pathogens focused on Nabs effect on those infected with HIV/AIDS by cell-to-cell contact. Dr. Alexandra Trkola from the University of Zurich, Switzerland, and her colleagues, developed an assay that can specifically test the potency of Nabs to prevent direct cell-to-cell transmission of HIV. By establishing an assay system, the free virus infection is restricted, resulting in infections only occurring through cell-to-cell transmissions. Researchers were able to test whether a large selection of Nabs could prevent cell-to-cell transmission of different HIV strains. Although Nabs showed an overall decrease in activity, losses varied substantially depending on the antibody and virus strain examined. Scientists also discovered certain Nabs still retained activity during cell-to-cell transmission for individual viruses. However, this was generally not linked to a high potency of the free virus, but instead, displayed Nabs inhibiting prior to the binding of the virus to the CD4 receptor on T cells. Mathematical analysis showed that when the virus was transmitted via cell to cell transmission, it was substantially more prone to give rise to mutation strains that can escape immune control compared to free virus transmissions. Dr. Trkola said: "This highlights the importance of controlling virus replication via the cell-cell transmission pathway even if the contribution of this transmission should provide to occur to a less extent than free virus spread in infected individuals." Written by Peter Lam

Mammography 'does not reduce breast cancer deaths'

Mammography for detection of breast cancer does not reduce the number of deaths from the disease and may actually lead to overdiagnosis, according to a new study published in JAMA Internal Medicine. While mammography was associated with a 16% increase in breast cancer diagnosis, researchers found it was not linked with a reduction in deaths from the disease. After skin cancer, breast cancer is the most common cancer among American women. Buy Aldara (Imiquimod) with no Rx Around 231,840 women in the US will be diagnosed with breast cancer this year, and around 40,290 will die from the disease. As with other cancers, early detection of breast cancer is key for successful treatment, and this can be achieved through breast cancer screening. Zantac (Ranitidine) with no Rx The main tool used for breast cancer screening is mammography, which involves taking an X-ray of each breast, allowing clinicians to see any tissue abnormalities. The US Preventive Services Task Force (USPSTF) recommend that women aged 50-74 have a mammogram every 2 years. According to the American Cancer Society, death rates from breast cancer have been falling since around 1989, and this is partly attributed to earlier detection as a result of breast cancer screening. However, study co-author Richard Wilson, of Harvard University in Cambridge, MA, and colleagues note that there is increasing concern that mammography may lead to overdiagnosis by "identifying small, indolent or regressive tumors that would not otherwise become clinically apparent," which means many women may receive treatment they do not necessarily need. What is more, although clinical trials have shown mammography is effective for early breast cancer diagnosis, Wilson and colleagues note that most of these trials are decades old. Methotrexate () with free Rx "There are concerns that the benefits and harms may have changed as treatments improved and screening was applied in general practice," they add. Breast cancer screening increased diagnosis by 16%, but did not reduce death rates For their study, the team set out to assess the link between rates of mammography for breast cancer detection and breast cancer incidence, tumor size and death rates from the disease. They analyzed data from the Surveillance, Epidemiology and End Results (SEER) cancer registries, involving more than 16 million women aged 40 and older from 547 counties in the US. About Clobevate with no prescription Breast cancer was diagnosed in 53,207 of these women during the 12-month period, and these women were followed-up over the next 10 years. The rate of breast cancer screening was assessed in each county, as determined by the percentage of women who underwent a mammogram in the previous 2 years. Buy Claritin (Loratadine) without prescription Overall breast cancer incidence in the year 2000 was calculated for each county, as was the rate of breast cancer deaths during the 10-year follow-up. Buy Milk Thistle online The team age-adjusted this data and applied it to the US population. The results of the analysis revealed a 10% rise in breast cancer screening. http://webmd-help.blogspot.com This was associated with a 16% increase in breast cancer diagnosis. However, no reduction was found in the rate of breast cancer deaths. In addition, the 10% increase in breast cancer screening was linked to a 25% rise in incidence of small breast cancers - defined as the presence of tumors 2 cm or less. However, the increase in breast cancer screening was not associated with a reduction in incidence of larger breast cancers - it was linked to a 7% increase. Commenting on their findings, Wilson and colleagues say: "Across US counties, the data show that the extent of screening mammography is indeed associated with an increased incidence of small cancers but not with decreased incidence of larger cancers or significant differences in mortality. What explains the observed data? The simplest explanation is widespread overdiagnosis, which increases the incidence of small cancers without changing mortality, and therefore matches every feature of the observed data." Clinicians right to be wary of breast cancer screening studies The researchers add, however, that clinicians are right to have concerns about ecological studies regarding breast cancer screening because of "ecological fallacy." Dr. Joann G. Elmore, of the University of Washington, agrees with this statement in a linked editorial. "It is well known, for example, that ecological studies provide no information as to whether the people who were actually exposed to the intervention were the same people who developed the disease, whether the exposure or the onset of disease came first, or whether there are other explanations for the observed association," she explains. As such, she says better tools and communication are required to help women make informed decisions about breast cancer screening. "Perhaps most important, we need to learn how to communicate with our patients about uncertainty and the limits of our scientific knowledge," she adds. "In the end, we all need to become comfortable with informing women that we do not know the actual magnitude of overdiagnosis with precision. Part of informed decision making is providing all the information, even our uncertainty." In contrary to these latest findings, a study reported by Medical News Today last month claims mammography is the best screening method for reducing breast cancer mortality among women aged 50 and older. Written by Honor Whiteman

Novel DNA repair mechanism could lead to new Alzheimer's treatments

Researchers have discovered a new mechanism with which DNA is repaired that could lead to further developments in the treatment and prevention of neurodegenerative disorders such as Alzheimer s disease. In the new study, the authors outline a new mechanism of DNA reparation by which single strand breaks previously deemed inaccessible can be repaired. Their findings are published in the American Association for the Advancement of Science s online-only journal Science Advances. The DNA damage response - consisting of mechanisms of detection, signaling and repair - is crucial for the health of the body, as unrepaired damage to DNA can lead to cell death and the development of severe conditions such as Alzheimer s disease. In particular, single-strand breaks (SSBs) "can interfere with transcription, replication, and DNA repair; induce accumulation of double-stranded DNA breaks [and] increase genomic instability and apoptosis," the authors write. DNA is bound alongside proteins in complexes referred to as nucleosomes. Buy Viagra Super Dulox-Force (Sildenafil Citrate + Duloxetine) with free Rx In nucleosomes, around 200 base pairs of DNA are wound around a core of histone proteins into two huge coiled loops. These coils are wound so tightly that molecules the length of around 2 meters can fit into microscopic cell nuclei. Arimidex (Anastrozole) with no prescription Lead researcher Vasily M. About Crixivan (Indinavir sulfate) without prescription Studitsky, a professor at Lomonov Moscow State University in Russia, explains that our entire genome is packed this way. However, due to the tight coiling, significant surfaces of the DNA are inaccessible - the surfaces interacting with the histones - and, as a result, certain SSBs are unrecognizable by the usual repair enzymes, known as PARP1. The discovery could herald new forms of drug treatment The researchers have discovered, however, that a special enzyme - the RNA polymerase II (Pol II) enzyme - can sense these SSBs by "riding" along the DNA coil. About Chlorsig Acting almost like a proofreader of a text, when the Pol II enzyme encounters an SSB, it triggers a number of reactions that lead to repair enzymes fixing the damaged area. "RNA polymerase can crawl along the DNA loops nearly as well as on histone-free DNA regions, but when it stops near locations of the DNA breaks, it panics, triggering the cascade of reactions to start DNA repairs, " Prof. About ED Medium Pack () with no prescription Studitsky explains. For the study, the researchers inserted SSBs into a model DNA system to observe how they would affect the progress of Pol II progressing along the coils. Buy Licorice online They discovered that this enzyme only stopped upon encountering breaks in the DNA connected to the histones and not in histone-free DNA. "These observations raise the possibility that nucleosomal structure could affect the process of detection and repair of DNA damages," the authors write. Prior to the study, the researchers had thought that DNA repair was only possible in histone-free DNA, as reparation with the previously identified mechanism would require complete unwinding of the DNA coils to make the SSBs accessible. Prof. http://pharmaceuticaljournal.wordpress.com Studitsky concludes that the discovery of a new method of DNA reparation promises new prospective methods of prevention and treatment of diseases: "We have shown that the formation of loops, which stop the polymerase, depends on its contacts with histones. If you make them more robust, it will increase the efficiency of the formation of loops and the probability of repair, which in turn will reduce the risk of disease. If these contacts are destabilized, then by using special methods of drug delivery you can program the death of the affected cells." Recently, Medical News Today reported on a study that discovered how a small molecule known for regulating gene expression plays a key role in progressing wounds through their healing stages. Written by James McIntosh

Traders' testosterone 'makes them take financial risks'

Researchers simulating the financial trading floor in the lab have found that traders hormone levels in the stressful, competitive environment are raised, making them invest in more risky assets. Cortisol is involved in the fight or flight response. The study, published in Scientific Reports, found that when given doses of either cortisol or testosterone, the participants buying and selling assets among themselves invested more in risky assets. They measured the volunteers natural hormone levels in one experiment and artificially raised them in another. Zofran (Ondansetron) without prescription "Our view is that hormonal changes can help us understand traders behavior, particularly during periods of financial instability," said Dr. About Azulfidine (Sulfasalazine) with no Rx Carlos Cueva, PhD, one of the lead authors of the study, from the department of economics at the University of Alicante, Spain. Cortisol is elevated in response to physical or psychological stress, increasing blood sugar and preparing the body for a fight-or-flight response. The authors suggest their findings could help with the development of more stable financial institutions. The paper s conclusion is: "Our results suggest that changes in both cortisol and testosterone could play a destabilizing role in financial markets through increased risk taking behavior, acting via different behavioral pathways." Dr. About Phoslo (Calcium Acetate) with no prescription Ed Roberts, from the department of medicine at the UK s Imperial College London and one of the lead authors of the study, says: "Our aim is to understand more about what these hormones do. Buy Cellcept with free Rx Then we can look at the environment in which traders work, and think about whether it s too stressful or too competitive. "These factors could be affecting traders hormones and having an impact on their decision-making." Saliva samples Some 142 volunteers, male and female, participated in the study, giving saliva samples for the measurement of the two hormones. They played an asset trading game in groups of around 10. About Esidrix (Hydrochlorothiazide) without Rx Those who had higher levels of cortisol were more likely to take risks, and high levels in the group were associated with instability in prices. In a second experiment, 75 young men were given either cortisol or testosterone before playing the game. Buy Joint Formulas online They were tested once while on the hormone and once while on a placebo. Both hormones had an effect toward greater risk-taking in investments. http://pharmaceutical-journal.blogspot.com Cortisol appeared to directly affect volunteers preference for riskier assets, while testosterone seemed to increase optimism about how prices would change in the future. Dr. Roberts says: "The results suggest that cortisol and testosterone promote risky investment behavior in the short run. "We only looked at the acute effects of the hormones in the lab. It would be interesting to measure traders hormone levels in the real world, and also to see what the longer term effects might be." Written by Markus MacGill

Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Harvoni®, the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. Buy Trecator-Sc (Ethionamide) without Rx (NASDAQ:GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Buy Combivir (Lamivudine - Zidovudine) Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved by the MHLW under the trade name Sovaldi® in March 2015. Viagra Pack-60 () without Rx Harvoni is indicated for the suppression of viremia in patients with genotype 1 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis, with a treatment duration of 12 weeks. “Today’s approval significantly advances the standard of care for chronic hepatitis C in Japan, as it eliminates the need for interferon and ribavirin, which can be difficult to take and to tolerate, and offers the majority of people with genotype 1 infection to be cured in as little as 12 weeks with a once-daily pill,” said Professor Masashi Mizokami, MD, PhD, The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine, Ichikawa, Japan. Primarily due to HCV, Japan has one of the highest rates of liver cancer of any industrialized country. Capecitabine with no prescription Of the more than one million people in Japan chronically infected with HCV, 70-80 percent are infected with the genotype 1 strain of the virus. Harvoni’s approval in Japan is supported by data from 318 treatment-na"ive and treatment-experienced Japanese patients with genotype 1 HCV infection randomized to ledipasvir/sofosbuvir (n=157) or ledipasvir/sofosbuvir plus ribavirin (n=161) in the Phase 3 clinical trial GS-US-337-0113. Hoodia () with free Rx Of the 318 patients enrolled in this study, 34 percent were ages 65 years or older and 23 percent had cirrhosis. Among patients receiving 12 weeks of ledipasvir/sofosbuvir without ribavirin, 100 percent (n=78/78) of treatment-na"ive and 100 percent (n=79/79) of treatment-experienced patients achieved sustained virologic response 12 weeks after completing therapy (SVR12). Buy Gymnema Sylvestre online Adverse events observed with ledipasvir/sofosbuvir without ribavirin were generally mild and included nasopharyngitis (29 percent), headache (7 percent) and malaise (6 percent). The approval is also supported by results from three Phase 3 studies (ION-1, ION-2 and ION-3) evaluating eight, 12 or 24 weeks of ledipasvir/sofosbuvir among genotype 1 HCV patients. http://medicalquestionanswers.wordpress.com Trial participants included patients from the United States, Europe and Puerto Rico who were treatment-na"ive or who had failed previous treatment, including protease inhibitor-based regimens, and also included patients with compensated cirrhosis. Trial participants in the ribavirin-free arms (n=1,080) achieved SVR12 rates of 94 to 99 percent. “Harvoni is a safe, simple and well-tolerated treatment. With cure rates of up to 100 percent and without the need for interferon or ribavirin, it offers genotype 1-infected patients a high likelihood of cure,” said Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development, and Chief Scientific Officer. “We are pleased to have partnered with the medical community in Japan to demonstrate the safety and efficacy of two significant advances in the treatment of chronic hepatitis C – Harvoni for genotype 1 infection and Sovaldi for genotype 2 infection, which was approved just three months ago. We look forward to making Harvoni available in Japan as quickly as possible.” Important Safety Information About Harvoni in Japan WarningsTreatment with Harvoni should be initiated by a physician with sufficient knowledge and experience in the management of patients with viral liver diseases who are appropriately diagnosed to receive the treatment. ContraindicationsHarvoni is contraindicated in the following patients: Patients with a history of hypersensitivity to the active substances or to any of the excipients; patients with severe renal function impairment (eGFR<30mL/min/1.73m2) or patients with renal insufficiency requiring dialysis. Contraindications for Coadministration Risk of Reduced Therapeutic Effect of Harvoni Due to P-gp Inducers: Carbamazepine, phenytoin, rifampin and St. John’s wort should not be administered with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations. Important Precautions Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with Harvoni due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia. Related Products Not Recommended: Harvoni is not recommended for use with other products containing sofosbuvir (Sovaldi). Adverse ReactionsThe major adverse reactions were pruritus (3.2 percent), nausea (2.5 percent) and stomatitis (2.5 percent). Drug InteractionsIn addition to carbamazepine, phenytoin, rifampin and St. John’s wort, coadministration of Harvoni is also not recommended with antacids, H2-receptor antagonists, proton-pump inhibitors, rifabutin and phenobarbital. Such coadministration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of Harvoni. Coadministration of Harvoni is not recommended with digoxin because the plasma concentration of digoxin may be increased. Coadministration is also not recommended with rosuvastatin or regimens containing tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively. Consult the full Prescribing Information for Harvoni for more information on potentially significant drug interactions, including clinical comments. Important Safety Information About Sovaldi in Japan WarningsTreatment with Sovaldi should be initiated by a physician with sufficient knowledge and experience in the management of patients with viral liver diseases who are appropriately diagnosed to receive the treatment. ContraindicationsSovaldi is contraindicated in the following patients: Patients with a history of hypersensitivity to the active substances or to any of the excipients; patients with severe renal function impairment (eGFR<30mL/min/1.73m2) or patients with renal insufficiency requiring dialysis. Contraindications for Coadministration Risk of Reduced Therapeutic Effect of Sovaldi Due to P-gp Inducers: Carbamazepine, phenytoin, rifampin and St. John’s wort should not be used with Sovaldi as they may significantly decrease sofosbuvir plasma concentration, reducing its therapeutic effect. Important PrecautionsSince Sovaldi is recommended for use in combination with ribavirin, the PRECAUTIONS of the ribavirin package insert, including Warnings, Contraindications, Careful Administration, Important Precautions, and Clinically Significant Adverse Reactions, must be consulted. Adverse ReactionsThe major adverse reactions observed in combination with ribavirin were anemia/hemoglobin decreased (15.0 percent), headache (5.0 percent), malaise (4.3 percent), nausea (4.3 percent) and pruritus (4.3 percent). Drug InteractionsIn addition to carbamazepine, phenytoin, rifampin and St. John’s wort, coadministration of Sovaldi is not recommended with phenobarbital and rifabutin. Such coadministration is expected to decrease the concentration of sofosbuvir, reducing its therapeutic effect. About GileadGilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California. Forward-Looking StatementThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including that physicians and patients may not see advantages of Harvoni over other therapies and may therefore be reluctant to prescribe the product, and the risk that payers may be reluctant to approve or provide reimbursement for the product. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements. U.S. full Prescribing Information for Sovaldi and Harvoni is available at .gilead.com. Sovaldi and Harvoni are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information on Gilead Sciences, please visit the company’s website at .gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Could a 'sniff test' lead to early autism diagnosis?

A new study published in the journal Current Biology has identified differences in the way people with autism respond to smells, suggesting a "sniff test" could be used for early diagnosis of the condition. Researchers say a sniff test may be a feasible way to diagnose autism early, after finding children with the disorder have different sniff responses to those without autism. Think of a pleasant smell - a bunch of flowers, for example. Buy Trecator-Sc (Ethionamide) without Rx You would likely take a big sniff in order to inhale the floral aroma. Buy Combivir (Lamivudine - Zidovudine) When it comes to bad smell, however, you would restrict the airflow in your nose to avoid inhaling it. Study author Noam Sobel, of the Weizmann Institute of Science in Israel, and colleagues found that children with autism are unable to make such adjustments - they sniff the same way regardless of whether they are presented with good or bad odors. In the US, around 1 in 68 children have been diagnosed with autism, the majority of whom are boys. Viagra Pack-60 () without Rx The condition is the fastest growing developmental disorder in the country. At present, there is no medical test for autism. Capecitabine with no prescription It is most commonly diagnosed via developmental screening, where a doctor assesses how a child moves, speaks, learns and behaves in order to determine whether there are any delays in these areas. But Sobel and colleagues say they may have uncovered a marker for autism, paving the way for a medical test for the condition. The team notes that past studies have suggested individuals with autism have impairments in areas of the brain responsible for sensory and motor coordination - known as "internal action models," or IAMs. "IAMs are brain templates that allow action initiation based on sensory expectations alone and ongoing refinement of motor output based on sensory input flow," they explain. Hoodia () with free Rx "Because the sniff response entails fine adjustment of a motor process (the sniff) in precise accordance with sensory input (the odor), it can be considered an IAM." The researchers set out to determine whether sniff response differs in children with autism, comparing the sniff response of 18 children with the disorder with that of 18 children free of the condition. Buy Gymnema Sylvestre online Sniff test identified autism with 81% accuracy The team created what they call a "computer-controlled air-dilution olfactometer equipped with a custom-designed double-barreled pediatric nasal cannula," allowing them to deliver different odors to the children while measuring their sniff response - determined by nasal airflow - at the same time. Using this device, the researchers delivered pleasant smells (rose or shampoo) and unpleasant smells (sour milk or rotten fish) to the children over a 10-minute period and measured their sniff response. They found that children without autism were able to adjust their sniff response within 305 milliseconds of being presented with an odor, while children with autism did not adjust their sniff response at all. The team says that using the differences they identified in sniff response between the two groups, they were able to identify the children as being with or without an autism diagnosis with 81% accuracy. In addition, they found that the more abnormal the sniffing response among children with autism, the more severe their social symptoms of autism were. http://medicalquestionanswers.wordpress.com "We propose that the altered IAM that is the sniff response leads to altered olfaction, which contributes to impaired social communication," say the authors. While the researchers note that further studies are needed to confirm their findings, their study opens to door to a sniff test that could be useful for early autism diagnosis. Sobel adds: "We can identify autism and its severity with meaningful accuracy within less than 10 minutes using a test that is completely nonverbal and entails no task to follow. This raises the hope that these findings could form the base for development of a diagnostic tool that can be applied very early on, such as in toddlers only a few months old. Such early diagnosis would allow for more effective intervention." Next, the researchers hope to determine whether olfactory impairment is involved social impairments among children with autism. They also plan to find out whether people with other neurodevelopmental conditions have similar sniff-response patterns to those identified in this study. Last month, Medical News Today reported on a study suggesting children with autism have enhanced visual search abilities from the age of 9 months - a finding that could one day lead to eye-tracking technology for early diagnosis. Written by Honor Whiteman

A new study published in the journal Current Biology has identified differences in the way people with autism respond to smells, suggesting a "sniff test" could be used for early diagnosis of the condition. Researchers say a sniff test may be a feasible way to diagnose autism early, after finding children with the disorder have different sniff responses to those without autism. Think of a pleasant smell - a bunch of flowers, for example. Buy Trecator-Sc (Ethionamide) without Rx You would likely take a big sniff in order to inhale the floral aroma. Buy Combivir (Lamivudine - Zidovudine) When it comes to bad smell, however, you would restrict the airflow in your nose to avoid inhaling it. Study author Noam Sobel, of the Weizmann Institute of Science in Israel, and colleagues found that children with autism are unable to make such adjustments - they sniff the same way regardless of whether they are presented with good or bad odors. In the US, around 1 in 68 children have been diagnosed with autism, the majority of whom are boys. Viagra Pack-60 () without Rx The condition is the fastest growing developmental disorder in the country. At present, there is no medical test for autism. Capecitabine with no prescription It is most commonly diagnosed via developmental screening, where a doctor assesses how a child moves, speaks, learns and behaves in order to determine whether there are any delays in these areas. But Sobel and colleagues say they may have uncovered a marker for autism, paving the way for a medical test for the condition. The team notes that past studies have suggested individuals with autism have impairments in areas of the brain responsible for sensory and motor coordination - known as "internal action models," or IAMs. "IAMs are brain templates that allow action initiation based on sensory expectations alone and ongoing refinement of motor output based on sensory input flow," they explain. Hoodia () with free Rx "Because the sniff response entails fine adjustment of a motor process (the sniff) in precise accordance with sensory input (the odor), it can be considered an IAM." The researchers set out to determine whether sniff response differs in children with autism, comparing the sniff response of 18 children with the disorder with that of 18 children free of the condition. Buy Gymnema Sylvestre online Sniff test identified autism with 81% accuracy The team created what they call a "computer-controlled air-dilution olfactometer equipped with a custom-designed double-barreled pediatric nasal cannula," allowing them to deliver different odors to the children while measuring their sniff response - determined by nasal airflow - at the same time. Using this device, the researchers delivered pleasant smells (rose or shampoo) and unpleasant smells (sour milk or rotten fish) to the children over a 10-minute period and measured their sniff response. They found that children without autism were able to adjust their sniff response within 305 milliseconds of being presented with an odor, while children with autism did not adjust their sniff response at all. The team says that using the differences they identified in sniff response between the two groups, they were able to identify the children as being with or without an autism diagnosis with 81% accuracy. In addition, they found that the more abnormal the sniffing response among children with autism, the more severe their social symptoms of autism were. http://medicalquestionanswers.wordpress.com "We propose that the altered IAM that is the sniff response leads to altered olfaction, which contributes to impaired social communication," say the authors. While the researchers note that further studies are needed to confirm their findings, their study opens to door to a sniff test that could be useful for early autism diagnosis. Sobel adds: "We can identify autism and its severity with meaningful accuracy within less than 10 minutes using a test that is completely nonverbal and entails no task to follow. This raises the hope that these findings could form the base for development of a diagnostic tool that can be applied very early on, such as in toddlers only a few months old. Such early diagnosis would allow for more effective intervention." Next, the researchers hope to determine whether olfactory impairment is involved social impairments among children with autism. They also plan to find out whether people with other neurodevelopmental conditions have similar sniff-response patterns to those identified in this study. Last month, Medical News Today reported on a study suggesting children with autism have enhanced visual search abilities from the age of 9 months - a finding that could one day lead to eye-tracking technology for early diagnosis. Written by Honor Whiteman