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News Article | April 24, 2017
Site: www.businesswire.com

NEW YORK--(BUSINESS WIRE)--#China--Medidata (NASDAQ:MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced an expanded partnership with WuXi Clinical Development Services (“WuXi CDS”), a wholly-owned subsidiary of the global pharmaceutical, biopharmaceutical and medical device open-access capability and technology platform company, WuXi AppTec. WuXi CDS is standardizing on the Medidata Clinical Cloud® to enhance its capabilities in early-phas


NEW YORK, May 04, 2017 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced two presentations on its novel investigational agent lumateperone at the 19th Annual Conference of the International Society for Bipolar Disorders (ISBD) being held in Washington, DC, May 4-7, 2017. An oral presentation (RC 04), titled "The Clinical Development of Lumateperone (ITI-007) for the Treatment of Bipolar Depression: Scientific Rationale and Clinical Design,” will be presented Friday, May 5, 2017 at 9:15 am ET during the Rapid Communication Session-Clinical. A poster presentation (POSII-19), titled "Activation of NMDA and AMPA Receptors by Lumateperone (ITI-007): Implications for Antidepressant Activity," occurs on Saturday, May 6, 2017, 8:00 am — 7:00 pm ET during Poster Session II. The oral presentation provides an overview of both clinical and preclinical data which form the scientific basis for the ongoing phase 3 clinical investigation of lumateperone as a treatment for bipolar depression. The poster presentation provides greater detail on new preclinical findings which further support and may predict rapid antidepressant activity of lumateperone. Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson’s and Alzheimer’s disease. The Company is developing its lead drug candidate, lumateperone (also known as ITI-007), for the treatment of schizophrenia, bipolar disorder, behavioral disturbances in patients with dementia, including Alzheimer’s disease, depression and other neuropsychiatric and neurological disorders. Lumateperone, a first-in-class molecule, is in Phase 3 clinical development for the treatment of schizophrenia, bipolar depression and agitation associated with dementia, including Alzheimer’s disease. The Company is also utilizing its phosphodiesterase platform and other proprietary chemistry platforms to develop drugs for the treatment of CNS and other disorders. This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, our clinical and non-clinical development plans; the progress, timing and results of our clinical trials and preclinical studies; the safety and efficacy of our product development candidates; our beliefs about the potential uses and benefits of lumateperone; and development efforts and plans under the caption “About Intra-Cellular Therapies.” All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include but are not limited to the following: our current and planned clinical trials, other studies for lumateperone, and our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA; our reliance on collaborative partners and other third parties for development of our product candidates; and the other risk factors detailed in our public filings with the Securities and Exchange Commission.  All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.


New Research Identifies Need for Patient-Centric Clinical Trials and Role for CROs New Research Identifies Patient-centric Strategies for Clinical Development with over 125 Global Research Opinion Leaders. Recognizing the upcoming need of distinct patient populations and understanding how CROs can play a role in running patient-centric trials, Life Science Strategy Group (LSSG) conducted research with 126 global opinion leaders involved in preclinical and clinical research at small, mid-sized, and large biopharmaceutical companies. LSSG found that up to 87% of respondents are discussing patient-centric approaches to clinical development, with half of the surveyed companies expecting to implement patient-centric approaches for clinical development within the next 1-3 years. "It is important to realize where Pharma is in its implementation of patient-centric strategies for clinical development today and to understand their needs in the future," said Jon Meyer, Life Science Strategy Group’s CRO Industry Practice Leader. Further, the research identifies that CROs need to play an increasing role as an enabler of success in patient-centric clinical trials. "Sponsors would like to see CROs research new and existing technologies such as data collection devices, patient-oriented websites and applications, and sample storage options, that enhance patient-centric trial approaches. This study gives us a glimpse at which CROs are best prepared to meet Pharma’s needs today and in the future," said Meyer. To learn more about LSSG’s new study examining patient-centric development trends as well as which CROs such as Covance, ICON, inVentiv Health Clinical, INC Research, Parexel, PPD, PRA International and QuintilesIMS are best prepared to address the new development needs, please contact Life Science Strategy Group or click on the link below. http://lifesciencestrategy.com/publications/cro-industry/pubs-cro-patient-centric-april-2017/ About Life Science Strategy Group, LLC Life Science Strategy Group, LLC specializes in strategic consulting and market research engagements across a variety of therapeutic, technology and service industries including contract research services, pharmaceutical, biotechnology, medical devices, diagnostics and drug discovery. Menlo Park, CA, April 28, 2017 --( PR.com )-- Life Science Strategy Group (LSSG) the leading strategic consulting firm to the CRO industry, is pleased to announce the results of a new 2017 study, "Patient-Centric Clinical Development Status and the Role of the Contract Research Organization (CRO)." which focuses on the current status and emerging trends of patient-centric clinical trials and the role CROs will play.Recognizing the upcoming need of distinct patient populations and understanding how CROs can play a role in running patient-centric trials, Life Science Strategy Group (LSSG) conducted research with 126 global opinion leaders involved in preclinical and clinical research at small, mid-sized, and large biopharmaceutical companies. LSSG found that up to 87% of respondents are discussing patient-centric approaches to clinical development, with half of the surveyed companies expecting to implement patient-centric approaches for clinical development within the next 1-3 years."It is important to realize where Pharma is in its implementation of patient-centric strategies for clinical development today and to understand their needs in the future," said Jon Meyer, Life Science Strategy Group’s CRO Industry Practice Leader.Further, the research identifies that CROs need to play an increasing role as an enabler of success in patient-centric clinical trials. "Sponsors would like to see CROs research new and existing technologies such as data collection devices, patient-oriented websites and applications, and sample storage options, that enhance patient-centric trial approaches. This study gives us a glimpse at which CROs are best prepared to meet Pharma’s needs today and in the future," said Meyer.To learn more about LSSG’s new study examining patient-centric development trends as well as which CROs such as Covance, ICON, inVentiv Health Clinical, INC Research, Parexel, PPD, PRA International and QuintilesIMS are best prepared to address the new development needs, please contact Life Science Strategy Group or click on the link below.About Life Science Strategy Group, LLCLife Science Strategy Group, LLC specializes in strategic consulting and market research engagements across a variety of therapeutic, technology and service industries including contract research services, pharmaceutical, biotechnology, medical devices, diagnostics and drug discovery. Click here to view the list of recent Press Releases from Life Science Strategy Group, LLC


Forum Extended Care Services, one of the largest independent long-term care (LTC) pharmacies in Illinois, is pleased to announce the promotion of Pete Toke, PharmD, FASCP, to Senior Vice President of Business & Clinical Development. Dr.


News Article | April 27, 2017
Site: www.prnewswire.com

In addition, Sue Friedman represented the patients' association Facing Our Risks of Cancer Empowered (FORCE), of which she is the Executive Director, with the aim of highlighting the importance of joint investigation and innovation in oncology by oncological centres, opinion leaders and patients. Representing the company's management team, José María Fernández, President of PharmaMar, presented the company's five-year growth plan following on from the basis of the  progress that has been delivered to date. "Today, PharmaMar has a treatment option that is accessible for oncological patients, but our project is to keep growing". In addition, Luis Mora, Managing Director of PharmaMar's Oncology Business Unit, added that the company's aims are directed at "being able to deliver three valid products for a minimum of five indications to the medical community in the near future, following the successful example of Yondelis®". The presentation by Arturo Soto, director of Clinical Development of PharmaMar´s Oncology Business Unit, included the earlier clinical data for Lurbinectedin in ovarian, small cell lung, breast and endometrial cancers, which preceded the current CORAIL and ATLANTIS Phase III studies with lurbinectedin which assess the efficacy in platinum-resistant ovarian cancer and in small-cell lung cancer, respectively. Information was also offered about several clinical trials in progress as well as a general vision of the company's strategy. Jose Luis Moreno, Director of Capital Markets also presented the company financials, balance sheet and income statement as of year-end 2016 and updated certain expectations for 2017. Finally, Pascal Besman, PharmaMar's Chief Operations Officer in the United States , told the attendees about the company's development plan in the country. This involves establishing a solid communication structure with key groups within the health system, patient and care giver associations, oncologists and the media. The meeting was recorded and the content will be available for viewing in the Events Calendar section of the website https://www.pharmamar.com.


-- Arrowhead Publishers is pleased to announce the 11th Annual Pain and Migraine Therapeutics Summit (www.paintherapeuticsummit.com)is coming to San Diego, CA on September 27-28, 2017. Leaders from the pharmaceutical, biotech, device and medical communities attend this conference to learn about the latest advances in the treatment of various types of pain. There are also extended networking opportunities, including a pre-conference networking site, to discuss new ideas with colleagues from industry, the non-profit sector, academia, the medical community, government and investors.This conference provides attendees with thoughtful insight from key industry leaders and academic researchers regarding cutting edge drug discovery science, preclinical development trends, analysis of key clinical-stage pain therapies and newly marketed products.We will highlight the most important developments in recent years in the field, including:·      Clinical Trial Design and Endpoints for Pain·      NGF Antagonist Research and Clinical Trial Data·      New Research in Biologic Therapy Development·      Sodium and Calcium Channel Block Research and Clinical Trials·      Abuse-resistant Opioid Drug Development·      Emerging Pain Research from Industry, Academia and Government·      The Latest Diagnostic Imaging Research·      Emerging Trends and New Animal Research·      Non-Opiate Pain Drug Development Trends and Clinical Development Programs·      The Genetic Components of PainArrowhead Publishers' annual Pain and Migraine Therapeutics Summit provides key stakeholders with a global meeting place to discuss the latest advancements in the field of pain research and therapeutics. For more information, visit: http://paintherapeuticsummit.com/ brochure For more information, please contact:John Waslif: Managing DirectorArrowhead Publishers866-945-0263 ext 700john.waslif@arrowheadpublishers.comRachel Donlon: Marketing AssociateArrowhead Publishers866-945-0263 ext 701rachel.donlon@arrowheadpublishers.com


News Article | May 4, 2017
Site: globenewswire.com

RALEIGH, N.C, May 04, 2017 (GLOBE NEWSWIRE) -- It is a little known fact that 70% of medicines given to children have been studied only in adults. As a result, most drugs used to treat diseases in children are used off-label. While there are pediatric clinical trial regulations in place, testing drugs in children continues to present considerable scientific, clinical, ethical and logistical challenges. In an effort to confront these challenges, PRA Health Sciences (NASDAQ:PRAH) is pleased to announce its new Center for Pediatric Clinical Development.  “PRA has a strong background in conducting pediatric clinical trials,” said Mark Sorrentino, Vice President, The Center for Pediatric Clinical Development. “We see this new center as an opportunity to establish PRA as the industry leader in pediatric drug development and bring innovation to pediatric clinical trial design and implementation.” PRA has conducted the pivotal and/or supportive trials to gain 12 FDA and/or international regulatory approvals for drugs used in treating pediatric patients across multiple therapeutic areas. The Center for Pediatric Clinical Development is supported by a cross-functional group of experts who will provide strategic pediatric product development consulting services as well as experienced technical and operational services. “This pediatric collaboration team provides the foundation for The Center for Pediatric Clinical Development,” added Sorrentino. “The team will provide pediatric expertise across functional areas into a single global resource to support all aspects of our clients’ pediatric product development needs.” The team will help navigate the complexities of pediatric trials and brings a wealth of knowledge in understanding the diverse country-specific regulatory and legal challenges in the pediatric environment. One of the many benefits of the center will be a site network to accelerate patient recruitment, and improve patient engagement and retention. PRA is one of the world's leading global contract research organizations, by revenue, providing outsourced clinical development services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 70 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East, and over 13,000 employees worldwide. Since 2000, PRA has participated in approximately 3,500 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 70 drugs. To learn more about PRA, please visit www.prahs.com.


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


Despite substantial morbidity associated with respiratory syncytial virus (RSV) infection, there is no licensed vaccine. MEDI-559 is a live attenuated intranasal vaccine candidate being developed for prevention of lower respiratory illness due to RSV in young children. This randomized, placebo-controlled study evaluated safety of MEDI-559 in healthy, RSV-seronegative children. MEDI-559 or placebo was administered on 3 occasions, 2 months apart. Primary safety was based on solicited symptoms (SSs) and adverse events (AEs) collected for 28 days after each dose. Nasal wash samples were collected 3 times after each dose (days 7-10, 12-18, 28-34) and at sick visits. Serum was collected for measuring antibody immune responses to RSV prior to first vaccination and 28 days post final dose. Long-term safety was monitored for 365 days from first dose. SSs were mild and frequent (MEDI-559 84%; placebo 91%); most common SSs were runny/stuffy nose, cough, and irritability/fussiness. AEs occurred in 67% MEDI-559 and 57% placebo recipients: most common AE was upper respiratory tract infection (MEDI-559 35%; placebo 23%). Higher incidence of medically attended lower respiratory illness within 28 days after dosing occurred in the MEDI-559 arm compared to placebo (none associated with vaccine virus shedding). There was no evidence of enhanced RSV disease. Vaccine virus was detected only in MEDI-559 recipients; shedding occurred in 56%subjects, primarily post dose 1. A functional immune response was observed in 59% and 9% MEDI-559 and placebo recipients, respectively, by an RSV microneutralization assay. Vaccine take, assessed by proportion that shed vaccine-type virus or had a seroresponse against RSV, was seen in 95% MEDI-559 subjects. MEDI-559 is therefore biologically active and immunogenic in this seronegative pediatric population. Although the frequency of SSs and AEs was not considered clinically significant, the increase in medically attended lower respiratory illnesses in the vaccine group warrants expanded safety studies. ClinicalTrials.gov NCT00767416.


Leon F.,Clinical Development
Journal of Immunological Methods | Year: 2011

This article reviews the multiple uses of flow cytometry in the diagnosis, monitoring and research of celiac disease, the most prevalent chronic autoimmune gastrointestinal disease. The phenotyping of intraepithelial lymphocytes (IELs) is of clinical relevance in the diagnosis of the disease given the characteristic features of elevated CD3+ IELs (αβ and γδ TcR) and the decrease in CD3- IELs. IEL biomarkers are also useful in the assessment of the response to the gluten-free diet and, importantly, in the diagnosis of the severe complications of celiac disease: refractory celiac disease and enteropathy-associated T-cell lymphoma. Novel applications of flow cytometry for the detection of anti-transglutaminase antibodies (a validated biomarker of celiac disease) and of gluten (the triggering antigen of the autoimmune process) are also discussed. The assessment of diagnostic and prognostic biomarkers by flow cytometry in celiac disease is performed routinely in a growing number of centers and it is an example of the versatility of this technique and its applicability to the research and clinical study of solid tissues. © 2010 Elsevier B.V.

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