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Caroline Lahrmann, a member of the DAA, objects to the DRO class action on behalf of her twins, who have profound intellectual and developmental disabilities. "The Americans with Disabilities Act is about protecting their rights as individuals and enabling them to make choices to best accommodate their unique disabilities and circumstances," says Lahrmann. "Without a range of choices, individuals with disabilities will be forced into a one-size-fits-all service model. Ultimately, people will be harmed and their opportunities diminished." DAA members disagree with the DRO's assertion that Intermediate Care Facilities (ICFs) and sheltered workshop environments are not as favorable as community living and working arrangements. While community homes benefit some individuals with disabilities, they are not appropriate for everyone. The parents, siblings and guardians who filed the motion know their loved ones need more intensive services and supports that are not available in a small community setting. Currently, the state of Ohio's Developmental Disabilities budget is heavily weighted toward community settings, with $1.9 billion directed toward community waiver services. In contrast, only $770 million is directed toward state-operated and privately-run ICFs. The DRO's class action seeks to widen this funding gap by taking money away from ICFs and sheltered workshops, which will likely force closures of many facilities. For Lahrmann and the parents and guardians who joined in the motion, closing important care options reduces choice, a basic tenet of the Americans with Disabilities Act. ICFs provide services such as licensed nursing, therapy and behavioral supports, personal care and 24-hour supervision. These are vital to addressing the requirements of those with complex needs such as severe and profound intellectual disabilities, quadriplegia, autism, epilepsy, maladaptive behaviors, non-verbal and requiring all nutrition through a gastrointestinal tube. Families opposing the DRO's action also say that ICF residents will be torn from the communities of friends and caregivers to which they have grown accustomed and formed attachments. Because they cannot afford legal counsel to fight lengthy litigation, the parents, siblings and guardians are representing the interests of their family members before the court. "The DRO is charged to protect and advocate the rights of all individuals with I/DD and serve as their publicly funded legal counsel," says Lahrmann. "By bringing this suit as a class action, however, DRO has marginalized a significant portion of its constituency from its services – those who cannot handle and benefit from community settings." The motion may be viewed here: http://nebula.wsimg.com/e3a89eb2227eb9d599c5b6a32897b98a?AccessKeyId=3AA4F2DE7107738E8E2F&disposition=0&alloworigin=1. About the Disability Advocacy Alliance The Disability Advocacy Alliance (DAA) is a volunteer organization which was formed in January 2015 by parents and family members to protect the rights of individuals with intellectual and developmental disabilities in Ohio. DAA's mission is faithful to the U.S. Supreme Court's Olmstead decision and the Americans with Disabilities Act (ADA).  Olmstead clearly states that an individual's choices are paramount in determining residential placement. It is with this legal foundation that DAA asserts that the Ohio Department of Developmental Disabilities must offer a range of residential, habilitation, and employment options to meet the diverse needs of individuals with intellectual and developmental disabilities. To learn more, please visit www.DisabilityAdvocacyAlliance.org. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/family-members-and-guardians-of-individuals-with-intellectual-and-developmental-disabilities-file-motion-to-maintain-options-for-care-300450850.html


News Article | April 20, 2017
Site: www.eurekalert.org

ILC 2017: Eight studies being presented at The International Liver Congress™ 2017 demonstrate contrasting evidence on the potential link between direct-acting antiviral treatment for hepatitis C and liver cancer According to data from eight studies being presented at The International Liver Congress™ 2017 in Amsterdam, The Netherlands, there remains continued debate on whether patients are at risk of developing liver cancer after achieving sustained virologic response (SVR) with a direct-acting antiviral (DAA) regimen for Hepatitis C virus (HCV). Investigators will present the results of their studies that show both sides of the argument - DAA therapy is associated with a higher risk of liver cancer compared with interferon-based therapy, versus there is no difference in liver cancer risk following cure with either therapy. Whilst remarkable progress has been made in the development of successful antiviral therapies for HCV infection, some recent studies suggest that curing patients does not eliminate the risk of developing liver cancer. There also appears to be an unexpectedly high rate of liver cancer (also known as hepatocellular carcinoma [HCC]) recurrence in patients who previously had their tumour treated successfully and had received DAAs.1 This claim was further supported by a Spanish study led by Dr Maria Reig and Dr Mariño, Hospital Clinic Barcelona, Spain in which patients with HCV and HCC who had previously been cured of HCC received DAA therapy. After a median 12.4 month follow-up, following treatment with DAAs, the rate of HCC coming back (recurrence) was 31.2% (24/77) and of those who received HCC treatment at recurrence, 30% (6/20) of patients presented progression in the immediate 6-month follow-up. This is an update of the study that will be published in the May 2017 issue of Seminars in Liver Disease, and is available here: https:/ . "Our study offers further support to previous findings that there is an unexpected high recurrence rate of hepatocellular carcinoma associated with DAAs, and that this association may result in a more aggressive pattern of recurrence and faster tumour progression," said Dr Maria Reig, Barcelona Clinic Liver Cancer Group, Hospital Clinic Barcelona, Spain, and lead author of the study. "These data indicate that there needs to be further research conducted in this area, clarifying the mechanism for the association between liver cancer recurrence and DAA therapy." Identifying those patients at risk of liver cancer is essential, a task that Dr Etienne Audureau, Public Health, Henri Mondor University Hospital, Créteil, France, and colleagues attempted to achieve by developing a prognostic tool for HCC. They found that in patients with severe scarring of the liver due to HCV (compensated cirrhosis), failure to achieve SVR was the most influential factor in predicting liver cancer. In addition, risk factors for liver cancer differ according to SVR status. The investigators recommend that in patients with compensated cirrhosis, eradication of HCV should be achieved before liver function is impaired and people who have achieved SVR should be monitored for liver cancer after 50 years of age. The mechanisms behind the development of liver cancer following HCV cure are not yet understood. One group of investigators led by Prof Thomas Baumert, Inserm Institute for Viral and Liver Diseases, University of Strasbourg, France, aimed to investigate if HCV infections produce epigenetic and transcriptional changes that persist after the infection is cured, and whether these epigenetic changes drive liver disease and HCC following cure. They found that the epigenetic and transcriptional changes are only partially reversed by DAAs and persist after HCV cure, suggesting that these changes are a driver for liver cancer that develops after HCV infection has been cured. The investigators concluded that these findings open a new perspective to develop novel biomarkers to identify patients at high risk of HCC and provide an opportunity to develop urgently needed strategies for HCC prevention. On the other side of the debate, a systematic review, meta-analyses, and meta-regression study, by Prof Gregory Dore and Dr Reem Waziry from The Kirby Institute, UNSW Sydney, and colleagues, found no evidence for higher risk of HCC occurrence or recurrence following DAA treatment, compared with interferon-based HCV therapy. A total of 41 studies, including 26 on HCC occurrence and 15 on HCC recurrence (in total, n=13,875 patients) were included. In studies assessing HCC occurrence, average follow up was shorter and average age was higher in DAA studies compared to interferon studies; incidence was lower with longer follow-up and younger age. In studies assessing HCC recurrence, average follow up was also shorter. Ultimately, in the meta-regression analysis, no evidence in favour of a differential HCC occurrence or recurrence was found between DAA and interferon regimens, after adjusting for study follow-up and age. "Recent studies have reported contradicting evidence on risk of hepatocellular carcinoma following direct-acting antiviral therapy; our aim was to bring some clarity to this," said Prof Gregory Dore, Kirby Institute and lead author of the study. "These data show the higher incidence of HCC observed following DAA therapy can be explained by the shorter duration of follow-up and older age of participants, rather than the DAA treatment regimen." A Scottish study, led by Dr Hamish Innes, School of Health and Life Sciences, Glasgow Caledonian University, Scotland, found that the risk of liver cancer following SVR was not associated with the use of DAAs, but baseline risk factors. Furthermore, risk of HCC development was similar in patients taking interferon-free regimens versus interferon-containing regimens, following a multivariate adjustment (IRR: 0.96, p=0.929) and no significant differences in HCC risk were found when treatment regimen was defined in terms of DAA containing regimens versus DAA free regimens. These data indicate that rather than the treatment regimens themselves, it is the baseline risk factors that determine risk of hepatocellular carcinoma. Another interesting study in Japanese patients with HCV genotype 1 infection, found a reduced incidence of liver cancer following achievement of SVR after 12 weeks of therapy with an interferon-free regimen (ledipasvir plus sofosbuvir) to a similar degree as that obtained with an interferon-containing regimen (simeprevir with peginterferon plus ribavirin). This study, which was conducted by Dr Masaaki Korenaga, Kohnodai Hospital, National Center for Global Health and Medicine, Chiba, Japan, and colleagues, also found that unexpected development of liver cancer following SVR in patients without previous liver cancer could potentially be predicted by imaging procedures (computer tomography or enhanced magnetic resonance imaging). Similarly, a Chinese study led by Dr George Lau, from the Beijing 302-Hong Kong Humanity and Health Hepatitis C Diagnosis and Treatment Centre, in Beijing, China, found no increase in the incidence of liver cancer in patients who achieved SVR12 with DAA compared to peginterferon plus ribavirin. A Sicilian study conducted by Dr Vincenza Calvaruso, University of Palermo, Palermo, Italy, and colleagues, demonstrated that patients who achieved SVR with DAAs had a similar risk of developing liver cancer when compared to historical controls of patients with compensated cirrhosis who achieved SVR after interferon-based therapy. In addition, those who achieved SVR with DAAs had a lower risk of developing liver cancer than those patients whose HCV infection was not cured. "The original observations made by researchers from the Barcelona Clinic Liver Cancer Group have sparked a huge number of studies aimed at verifying the potential association between DAA treatment and increased HCC recurrence after cure," said Prof Francesco Negro, Divisions of Gastroenterology and Hepatology of Clinical Pathology, University Hospital of Geneva, and EASL Governing Board Member. "At this stage, there is no reason to alter treatment guidelines until the issue is definitively clarified. We cannot exclude, however, that we may have to revise post-SVR surveillance in some specific patient subgroups." This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ 2017 will take place from April 19 - 23, at the RAI Amsterdam, Amsterdam, The Netherlands. About The European Association for the Study of the Liver (EASL) Since its foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European Association with international influence, with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy. Contact For more information, please contact the ILC Press Office at: Session title: Parallel session: Liver tumours: from patient stratification to management Time, date, and location of session: 16:00 - 18:00, Thursday 20 April, Elicium 2 Abstract: No evidence for higher risk of hepatocellular carcinoma occurrence or recurrence following direct-acting antiviral HCV therapy: A systematic review, meta-analyses, and meta-regression (PS160), 16:00 - 16:15 Gregory Dore, Australia Session title: Parallel session: HCV: post SVR management and complications Time, date, and location of session: 16:00 - 18:00, Thursday 20 April, Hall 5 Abstracts presented in order of appearance in press release: Tumour recurrence after Interferon-free treatment for hepatitis C in patients with previously treated hepatocellular carcinoma discloses a more aggressive pattern and faster tumour growth (PS031), 16:00 - 16:15 Maria Reig, Spain Identifying residual risk of hepatocellular carcinoma following hepatitis C virus eradication in compensated cirrhosis: decision-tree and random forest models developed in the French multicenter prospective ANRS CO12 CirVir cohort (PS034), 16:45 - 17:00 Etienne Audureau, France Hepatitis C virus-induced epigenetic and transcriptional changes persist post cure (PS033), 16:30 - 16:45 Thomas Baumert, France Among cirrhotic patients with a hepatitis C sustained viral response, the risk of de-novo hepatocellular carcinoma relates to baseline factors and not the use of direct acting antivirals: results from a nationwide cohort (PS035), 17:00 - 17:15 Hamish Innes, United Kingdom Sustained virologic response by ledipasvir/sofosbuvir reduces the incidence of hepatocellular carcinoma in Japanese patients with HCV genotype 1 infection. - Comparison with Simeprevir with peginterferon plus ribavirin (PS036), 17:15 - 17:30 Masaaki Korenaga, Japan No increase in the occurrence rate of hepatocellular carcinoma in Chinese treated by direct-acting antivirals compared to Interferon after eradication of hepatitis c virus: A long-term follow-up (PS037), 17:30 - 17:45 George Lau, China Occurrence of hepatocellular carcinoma in patients with hepatitis C virus related liver disease treated with direct-acting antivirals (PS038), 17:45 - 18:00 Vincenza Calvaruso, Italy Gregory Dore: Advisory board member and receives honorarium from Gilead, Merck, Abbvie, Bristol-Myers Squibb, Janssen, has received research grant funding from Gilead, Merck, Abbvie, Bristol-Myers Squibb, Janssen, and travel sponsorship from Gilead, Merck, Abbvie, and Bristol-Myers Squibb Vincenza Calvaruso: Advisory Board for AbbVie, BMS, Gilead Sciences and Intercept. Grant and research support for MSD 1 Reig M et al. Unexpected early tumor recurrence in patients with HCV-related HCC undergoing interferon-free therapy; a note of caution. J Hepatol. 2016;65:719-726.


News Article | April 21, 2017
Site: marketersmedia.com

LONDON, UK / ACCESSWIRE / April 21, 2017 / Active Wall St. blog coverage looks at the headline from AbbVie Inc. (NYSE: ABBV) as the Company announced on April 20, 2017, that its Phase 3 EXPEDITION-1 study demonstrated that 99% of chronic hepatitis C virus (HCV) infected patients achieved sustained virologic response at 12 weeks' post-treatment (SVR12) with its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P). Register with us now for your free membership and blog access at: http://www.activewallst.com/register/. One of AbbVie's competitors within the Drug Manufacturers - Major space, Impax Laboratories, Inc. (NASDAQ: IPXL), announced on April 06, 2017, that it will release its Q1 2017 financial results on Wednesday, May 10, 2017, prior to the open of the US financial markets. The Company will host a conference call and live webcast with the investment community at 8:30 a.m., ET on May 10, 2017. AWS will be initiating a research report on Impax Labs in the coming days. Today, AWS is promoting its blog coverage on ABBV; touching on IPXL. Get all of our free blog coverage and more by clicking on the link below: http://www.activewallst.com/register/. AbbVie's EXPEDITION-1 is a single arm, multicenter, open-label study evaluating the efficacy and safety of 12 weeks of G/P in adults with GT1, 2, 4, 5 or 6 chronic HCV infection and compensated cirrhosis (Child-Pugh A) in 146 patients, including those new to treatment or had prior treatment experience with IFN-based treatments. The primary endpoint was the percentage of patients achieving SVR12. SVR12 was achieved by 145/146 patients, with one GT1a-infected patient experiencing relapse. These high SVR12 rates were seen following 12 weeks of G/P treatment without ribavirin. Patients with specific virus strains associated with resistance or with a high quantity of the virus in their bloodstream before treatment initiation were not excluded from the study. "We have already seen great progress in the treatment of HCV patients with compensated cirrhosis. However, treatment challenges remain related to the use of ribavirin," said Xavier Forns, M.D., head of hepatitis unit, Hospital Clinic de Barcelona, Spain, "The positive findings from the EXPEDITION-1 study, along with previously reported data, show that G/P has the potential to become a ribavirin-free treatment for patients with compensated cirrhosis across these genotypes." In the EXPEDITION-1 study, the majority of adverse events (AEs) were mild and no patients discontinued treatment due to an AE. The most common AEs were fatigue and headache. No patients experienced ALT elevations equal to or above Grade 3. Of the 11 patients who experienced serious AEs, none were considered treatment-related. Approximately 130 to 150 million people worldwide are living with chronic HCV, for whom the risk of cirrhosis of the liver is between 15-30% within 20 years. Treatment guidelines around the world recommend that all patients with cirrhosis should be considered for treatment, yet the treatment of specific patients with HCV and compensated cirrhosis is still challenging. AbbVie's glecaprevir/pibrentasvir (G/P) is an investigational, pan-genotypic regimen being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment with direct-acting antivirals (DAA), which make up the majority of HCV patients. AbbVie's G/P is a once-daily regimen that combines two distinct antiviral agents. G/P is a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral tablets. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with CKD, including patients on dialysis. Authorization applications for G/P are currently under review by regulatory authorities around the world. G/P has been granted accelerated assessment by the European Medicines Agency (EMA), and priority review designations by the US Food and Drug Administration (FDA), and Japanese Ministry of Health, Labor and Welfare (MHLW). On Thursday, April 20, 2017, the stock closed the trading session at $63.78, slightly up 0.52% from its previous closing price of $63.45. A total volume of 5.70 million shares have exchanged hands. AbbVie's stock price advanced 4.94% in the last three months, 5.71% in the past six months, and 9.53% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have gained 3.90%. The stock is trading at a PE ratio of 17.47 and has a dividend yield of 4.01%. Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below. AWS has not been compensated; directly or indirectly; for producing or publishing this document. The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst [for further information on analyst credentials, please email info@activewallst.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by AWS. AWS is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way. AWS, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. AWS, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, AWS, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice. This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither AWS nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://www.activewallst.com/disclaimer/. For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at: CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute. LONDON, UK / ACCESSWIRE / April 21, 2017 / Active Wall St. blog coverage looks at the headline from AbbVie Inc. (NYSE: ABBV) as the Company announced on April 20, 2017, that its Phase 3 EXPEDITION-1 study demonstrated that 99% of chronic hepatitis C virus (HCV) infected patients achieved sustained virologic response at 12 weeks' post-treatment (SVR12) with its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P). Register with us now for your free membership and blog access at: http://www.activewallst.com/register/. One of AbbVie's competitors within the Drug Manufacturers - Major space, Impax Laboratories, Inc. (NASDAQ: IPXL), announced on April 06, 2017, that it will release its Q1 2017 financial results on Wednesday, May 10, 2017, prior to the open of the US financial markets. The Company will host a conference call and live webcast with the investment community at 8:30 a.m., ET on May 10, 2017. AWS will be initiating a research report on Impax Labs in the coming days. Today, AWS is promoting its blog coverage on ABBV; touching on IPXL. Get all of our free blog coverage and more by clicking on the link below: http://www.activewallst.com/register/. AbbVie's EXPEDITION-1 is a single arm, multicenter, open-label study evaluating the efficacy and safety of 12 weeks of G/P in adults with GT1, 2, 4, 5 or 6 chronic HCV infection and compensated cirrhosis (Child-Pugh A) in 146 patients, including those new to treatment or had prior treatment experience with IFN-based treatments. The primary endpoint was the percentage of patients achieving SVR12. SVR12 was achieved by 145/146 patients, with one GT1a-infected patient experiencing relapse. These high SVR12 rates were seen following 12 weeks of G/P treatment without ribavirin. Patients with specific virus strains associated with resistance or with a high quantity of the virus in their bloodstream before treatment initiation were not excluded from the study. "We have already seen great progress in the treatment of HCV patients with compensated cirrhosis. However, treatment challenges remain related to the use of ribavirin," said Xavier Forns, M.D., head of hepatitis unit, Hospital Clinic de Barcelona, Spain, "The positive findings from the EXPEDITION-1 study, along with previously reported data, show that G/P has the potential to become a ribavirin-free treatment for patients with compensated cirrhosis across these genotypes." In the EXPEDITION-1 study, the majority of adverse events (AEs) were mild and no patients discontinued treatment due to an AE. The most common AEs were fatigue and headache. No patients experienced ALT elevations equal to or above Grade 3. Of the 11 patients who experienced serious AEs, none were considered treatment-related. Approximately 130 to 150 million people worldwide are living with chronic HCV, for whom the risk of cirrhosis of the liver is between 15-30% within 20 years. Treatment guidelines around the world recommend that all patients with cirrhosis should be considered for treatment, yet the treatment of specific patients with HCV and compensated cirrhosis is still challenging. AbbVie's glecaprevir/pibrentasvir (G/P) is an investigational, pan-genotypic regimen being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment with direct-acting antivirals (DAA), which make up the majority of HCV patients. AbbVie's G/P is a once-daily regimen that combines two distinct antiviral agents. G/P is a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral tablets. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with CKD, including patients on dialysis. Authorization applications for G/P are currently under review by regulatory authorities around the world. G/P has been granted accelerated assessment by the European Medicines Agency (EMA), and priority review designations by the US Food and Drug Administration (FDA), and Japanese Ministry of Health, Labor and Welfare (MHLW). On Thursday, April 20, 2017, the stock closed the trading session at $63.78, slightly up 0.52% from its previous closing price of $63.45. A total volume of 5.70 million shares have exchanged hands. AbbVie's stock price advanced 4.94% in the last three months, 5.71% in the past six months, and 9.53% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have gained 3.90%. The stock is trading at a PE ratio of 17.47 and has a dividend yield of 4.01%. Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below. AWS has not been compensated; directly or indirectly; for producing or publishing this document. The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst [for further information on analyst credentials, please email info@activewallst.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by AWS. AWS is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way. AWS, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. AWS, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, AWS, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice. This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither AWS nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://www.activewallst.com/disclaimer/. For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at: CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.


News Article | April 21, 2017
Site: www.accesswire.com

LONDON, UK / ACCESSWIRE / April 21, 2017 / Active Wall St. blog coverage looks at the headline from AbbVie Inc. (NYSE: ABBV) as the Company announced on April 20, 2017, that its Phase 3 EXPEDITION-1 study demonstrated that 99% of chronic hepatitis C virus (HCV) infected patients achieved sustained virologic response at 12 weeks' post-treatment (SVR12) with its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P). Register with us now for your free membership and blog access at: http://www.activewallst.com/register/. One of AbbVie's competitors within the Drug Manufacturers - Major space, Impax Laboratories, Inc. (NASDAQ: IPXL), announced on April 06, 2017, that it will release its Q1 2017 financial results on Wednesday, May 10, 2017, prior to the open of the US financial markets. The Company will host a conference call and live webcast with the investment community at 8:30 a.m., ET on May 10, 2017. AWS will be initiating a research report on Impax Labs in the coming days. Today, AWS is promoting its blog coverage on ABBV; touching on IPXL. Get all of our free blog coverage and more by clicking on the link below: http://www.activewallst.com/register/. AbbVie's EXPEDITION-1 is a single arm, multicenter, open-label study evaluating the efficacy and safety of 12 weeks of G/P in adults with GT1, 2, 4, 5 or 6 chronic HCV infection and compensated cirrhosis (Child-Pugh A) in 146 patients, including those new to treatment or had prior treatment experience with IFN-based treatments. The primary endpoint was the percentage of patients achieving SVR12. SVR12 was achieved by 145/146 patients, with one GT1a-infected patient experiencing relapse. These high SVR12 rates were seen following 12 weeks of G/P treatment without ribavirin. Patients with specific virus strains associated with resistance or with a high quantity of the virus in their bloodstream before treatment initiation were not excluded from the study. "We have already seen great progress in the treatment of HCV patients with compensated cirrhosis. However, treatment challenges remain related to the use of ribavirin," said Xavier Forns, M.D., head of hepatitis unit, Hospital Clinic de Barcelona, Spain, "The positive findings from the EXPEDITION-1 study, along with previously reported data, show that G/P has the potential to become a ribavirin-free treatment for patients with compensated cirrhosis across these genotypes." In the EXPEDITION-1 study, the majority of adverse events (AEs) were mild and no patients discontinued treatment due to an AE. The most common AEs were fatigue and headache. No patients experienced ALT elevations equal to or above Grade 3. Of the 11 patients who experienced serious AEs, none were considered treatment-related. Approximately 130 to 150 million people worldwide are living with chronic HCV, for whom the risk of cirrhosis of the liver is between 15-30% within 20 years. Treatment guidelines around the world recommend that all patients with cirrhosis should be considered for treatment, yet the treatment of specific patients with HCV and compensated cirrhosis is still challenging. AbbVie's glecaprevir/pibrentasvir (G/P) is an investigational, pan-genotypic regimen being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment with direct-acting antivirals (DAA), which make up the majority of HCV patients. AbbVie's G/P is a once-daily regimen that combines two distinct antiviral agents. G/P is a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral tablets. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with CKD, including patients on dialysis. Authorization applications for G/P are currently under review by regulatory authorities around the world. G/P has been granted accelerated assessment by the European Medicines Agency (EMA), and priority review designations by the US Food and Drug Administration (FDA), and Japanese Ministry of Health, Labor and Welfare (MHLW). On Thursday, April 20, 2017, the stock closed the trading session at $63.78, slightly up 0.52% from its previous closing price of $63.45. A total volume of 5.70 million shares have exchanged hands. AbbVie's stock price advanced 4.94% in the last three months, 5.71% in the past six months, and 9.53% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have gained 3.90%. 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AbbVie will present late-breaking studies on two investigational treatments for moderately to severely active Crohn's disease during the Clinical Science: Late-Breaking Abstract Plenary Session on Tuesday, May 9. The late-breaking research includes a Phase 2 study that evaluates the safety and efficacy of multiple dosing regimens of upadacitinib as induction therapy in patients with moderately to severely active Crohn's disease after 16 weeks of treatment. The majority of these patients had failed two or more biologics. Upadacitinib is an investigational oral JAK1-selective inhibitor, which targets an inflammatory pathway that plays an important role in Crohn's disease and several other chronic immune-mediated conditions. AbbVie will also present a Phase 2, open-label maintenance therapy study that evaluates clinical and endoscopic remission, and clinical and endoscopic response of risankizumab at one year in patients with moderately to severely active Crohn's disease. Risankizumab selectively blocks interleukin-23 (IL-23), a key signaling agent that has been linked to a number of chronic immune-mediated diseases. Risankizumab is an investigational treatment that is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialization of risankizumab globally. Additionally, AbbVie will present new HUMIRA analyses, including an evaluation of patients with ulcerative colitis treated in a clinical practice setting, an evaluation of the long-term safety of HUMIRA in patients with moderately to severely active Crohn's disease, and an evaluation of the efficacy of HUMIRA in anti-tumor necrosis factor-naïve pediatric patients with Crohn's disease. HUMIRA is one of the most comprehensively studied biologics available for immune-mediated diseases and is supported by more than 14 years of clinical trial experience in inflammatory bowel disease (Crohn's disease and ulcerative colitis).1 Data from AbbVie's hepatitis C virus (HCV) clinical development program will be presented in six presentations throughout the meeting. These studies provide primary and integrated analysis of treatment with its investigational, once-daily, ribavirin-free, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) in patients across all major genotypes (GT1-6). The results investigate the potential of G/P in patients with specific treatment challenges and explore a virologic cure* in as little as 8 weeks of treatment for HCV patients without cirrhosis and those new to treatment, who make up the majority of HCV patients. The new drug application (NDA) for G/P has been accepted by the U.S. Food and Drug Administration (FDA) with priority review designation and is currently under review. G/P is an investigational regimen and its safety and efficacy has not been established. *Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C. Abstracts are available here. About HUMIRA in the U.S. Uses2 HUMIRA is a prescription medicine used: Important Safety Information2 HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body's ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy, even if their TB test was negative. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, as these infections may happen or become more severe if people use HUMIRA. People should tell their doctor if they have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores. For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated. Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with anakinra or abatacept is not recommended. People using HUMIRA should not receive live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA. Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea. HUMIRA is given by injection under the skin. The benefits and risks of HUMIRA should be carefully considered before starting therapy. Please click here for the Full Prescribing Information and Medication Guide. About AbbVie's HCV Clinical Development Program AbbVie's glecaprevir/pibrentasvir (G/P) clinical development program was designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing treatment areas of continued unmet need. G/P is an investigational, pan-genotypic regimen being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment with direct-acting antivirals (DAA)**, who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with CKD, including patients on dialysis. G/P is a once-daily regimen that combines two distinct antiviral agents. G/P is a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral tablets. Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. *Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.  **Patients who are treatment-naive or had prior treatment experience with IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN). About AbbVie AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn. Forward-Looking Statements  Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2016 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 1 Hanauer SB, Sandborn WJ, Rutgeerts P, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology. 2006;130(2):323-333.  2 HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/abbvie-demonstrates-leadership-in-gastroenterology-and-hepatology-with-new-data-and-late-breaking-studies-to-be-presented-at-digestive-disease-week-300451228.html


News Article | May 29, 2017
Site: www.marketwired.com

VICTORIA, BC--(Marketwired - May 29, 2017) - Vecima Networks Inc. (TSX: VCM), an experienced designer and manufacturer of innovative technology in the broadband equipment market, is pleased to announce the launch of the Entra Access Switch at ANGA COM 2017. Vecima's Entra Access Switch is designed to extend the capacity of networks with insufficient fibers while minimizing the use of expensive digital optics. The Entra Access Switch significantly reduces capital costs for short run fiber extensions, deep fiber deployments, and DOCSIS 3.1 node aggregations, ensuring the maximum ROI from existing short and long range fiber links. An outdoor centrally managed 8 port x 10GbE weatherproof network switch, it is capable of supporting Carrier Ethernet services in almost any deployment environment. A unique feature of the Entra Access Switch is its rugged versatility. Being strand mountable, it can be placed at the edge of a broadband access network to support businesses, mobile network backhaul and DOCSIS 3.1 distributed access architecture (DAA) aggregation. "In terms of customer reach and use, the capabilities of the Entra Access Switch are quite broad," said Sumit Kumar, Vecima's President and CEO. "We're seeing several use cases emerging, many of which are tied to fibre savings, fibre-to-commercial premises, and empowering distributed access where using the Entra Access Switch to feed DOCSIS nodes deeper in the network is an elegant approach." To learn more about Vecima's Entra Access Switch, please visit Hall 7, Booth #C72 at ANGA COM in Cologne, Germany or find additional product details at www.vecima.com/entra-access-switch. About Vecima Networks Vecima Networks Inc. (TSX: VCM) is a globally recognized leader in creating breakthrough technology solutions that empower network service providers to connect people and enterprises to information and entertainment worldwide. Vecima products for the cable industry allow service providers a cost-effective Last Mile Solution® for both video and broadband access, especially in the demanding business services market segment. Vecima also provides fleet managers the key information and analytics they require to optimally manage their business under the Contigo, Nero Global Tracking, and FleetLynx brands. More information is available at our website at www.vecima.com.


News Article | May 23, 2017
Site: www.foodprocessing-technology.com

Swiss-Irish baked foods company Aryzta has appointed former Glanbia USA senior executive Kevin Toland as its new chief executive. Toland is currently serving as chief executive for airport operator DAA and will join Aryzta after a six-month notice period. This appointment comes just more than three months following the previous CEO Owen Killian’s announcement to resign at the end of the current fiscal period in July. Killian has been serving Aryzta as CEO and executive director since 2008. “The quality and strength of the Aryzta franchise attracted a number of high-quality candidates." Earlier this month, the firm stated that it was exploring options for its 49% interest in French food company Picard. Aryzta was established with the merger of IAWS Group and Hiestand. Toland has been serving as CEO with DAA, which was previously called as Dublin Airport Authority, since 2013. Besides being a president and CEO of Glanbia USA and Global Nutritionals, he also served in several senior positions at Glanbia, including as group development director and chief executive of consumer foods unit. Aryzta chairman Gary McGann was quoted by Foodbusinessnews.net as saying: “The quality and strength of the Aryzta franchise attracted a number of high-quality candidates. “Kevin has an outstanding track record of delivering strategically, operationally and financially. He is a proven CEO. of businesses undergoing significant transformation and brings extensive experience of the food sector.”


News Article | May 15, 2017
Site: www.businesswire.com

Avant de rejoindre Visual IQ, St. Amand travaillait chez Brand Networks, fournisseur primé de solutions de publicité intercanaux sur les réseaux sociaux. En tant que directeur marketing, il était chargé de l’expansion internationale, via la conduite de projets marketing valorisant la société et ses produits. Chez Visual IQ, il mettra à profit sa connaissance approfondie du secteur des technologies marketing et son expérience en matière de création de parcours client pertinents et unifiés pour promouvoir la plateforme d’intelligence marketing réputée de Visual IQ. Combinant données d’audience et savoir-faire en matière d’attribution, cette plateforme fournit aux spécialistes du marketing les données exploitables dont ils ont besoin pour optimiser les budgets et générer d’excellents résultats, ainsi que créer des expériences plus pertinentes et attrayantes pour les consommateurs. « La solide expérience et la réputation de Wayne dans les technologies du marketing soutiennent notre ambition de fournir le meilleur logiciel d’intelligence marketing au monde, afin de permettre aux spécialistes du marketing d’adopter une approche centrée sur l’audience tout en favorisant une efficacité et des performances supérieures », déclare Manu Mathew, cofondateur et PDG de Visual IQ. « Nous sommes ravis d’accueillir Wayne dans l’équipe Visual IQ et avons hâte de profiter de sa passion pour le marketing axé sur le facteur humain et l’avenir de l’intelligence marketing ». « Les bons spécialistes du marketing savent que la réussite ou l’échec d’une marque repose en grande partie sur l’expérience des consommateurs et que, pour offrir la meilleure expérience possible sur différents canaux et appareils, il faut mettre les personnes au premier plan », affirme St. Amand. « En regroupant sur une seule et même plateforme des informations sur l’audience et des conseils tactiques en matière de performance marketing, Visual IQ est extrêmement bien placée pour fournir les informations nécessaires à la réussite d’une stratégie marketing axée sur le facteur humain. Travailler dans le secteur du marketing et de la publicité n’a jamais été aussi passionnant et je suis enchanté de rejoindre Visual IQ ». Visual IQ est le leader mondial des solutions d’intelligence marketing. Combinant données d’audience et mesures d’attribution dans une plateforme unique, sa solution IQ Intelligence Suite fournit des informations de performance marketing et publicitaire sur la base du segment d’audience, ainsi que des recommandations d’optimisation intercanaux et intracanaux permettant d’atteindre les objectifs métier et de maximiser le retour sur investissement. En proposant des fonctions de modélisation du média mix, d’attribution TV et d’attribution multicontact dans une plateforme consolidée, Visual IQ est la seule société qui fournit des informations exhaustives sur l’audience, répondant ainsi aux besoins des marques et agences pour optimiser les performances de leur marketing mix et publicitaire. Visual IQ a été désignée leader de l’attribution intercanaux par l’un des principaux cabinets d’étude du secteur quatre fois de suite, a remporté le prix de la Meilleure solution d’attribution aux Drum Digital Trading Awards en 2015 et 2016, a également remporté le prix ASPY 2014 dans la catégorie Meilleure solution de gestion de données ou d’analytique, et a été retenue comme finaliste pour le prix d’excellence de la DAA (Digital Analytics Association) en 2013, 2014, 2015 et 2016. L’entreprise est membre de l’IAB aux États-Unis, membre de l’Association marketing canadienne, et siège aux conseils Advertising Technology, Data, Public Policy et CFO de l’IAB, ainsi qu’à la commission de normalisation de la DAA.


Most patients with hepatitis C virus can be cured by direct-acting antiviral agents (DAAs), but some with the more serious decompensated cirrhosis fail to improve or experience further deterioration even after treatment. Dr. Dunn's team focused on the Rs738409 single nucleotide polymorphism, which is a variation in a single base pair of DNA in the PNPLA3 gene; patients possess one of three genotypes — CC, CG, or GG. The PNPLA3 gene is the most important genetic risk factor for both alcoholic liver disease and nonalcoholic fatty liver disease. The team followed 32 patients with decompensated cirrhosis who had initially achieved sustained virologic response (SVR). They had become essentially virus-free, using interferon-free DAAs. Twelve to 48 weeks after SVR, researchers tracked changes in the Model for End-Stage Liver Disease (MELD) and the Child-Pugh (CPT) scores, measures that assess the severity of chronic liver disease. Following DAA treatment, researchers found that five of the 16 patients with the CG or GG genotypes experienced worsened MELD or CPT scores. In comparison, only one patient with the CC genotype worsened in either score. "These findings suggest screening for the Rs738409 CG and GG genotypes in hepatitis C patients with decompensated cirrhosis can help to identify individuals who are less likely to recover after achieving a 'cure' of their hepatitis C," added Dr. Dunn. Financial support for this study was provided by the Frontiers Pilot and Collaborative Studies Funding Program. Digestive Disease Week (DDW) 2017 is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. More information can be found at www.ddw.org. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/study-identifies-genetic-markers-that-predict-which-patients-with-hepatitis-c-and-cirrhosis-will-improve-with-treatment-300454288.html


Patent
DAA Inc | Date: 2016-07-13

A method of treating and preventing infection using an effective concentration of xylitol in a pharmaceutical composition.

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