News Article | April 25, 2017
ALBUQUERQUE, N.M.--(BUSINESS WIRE)--Optomec, a leading global supplier of production grade additive manufacturing systems for 3D printed electronics, announced today that the company, along with its partner Wong’s Kong King Ltd (WKK), will showcase its Aerosol Jet systems for 3D printed electronics at NEPCON China in Shanghai. The conference/expo will be held April 25-27 at the Shanghai World Expo and Convention center in China. Optomec will be located in the WKK booth # 1-F50 in Hall 1. At the expo, Optomec will display next generation 3D printed electronic devices used in consumer electronics, semiconductor packaging and Internet of Things applications. Also in the WKK booth, Optomec will showcase a video highlighting the use of Aerosol Jet technology in mass production at the LITE-ON Mobile Mechanical SBG (LITE-ON) factory in Guangzhou, China. For over one year, multiple Aerosol Jet production systems have been operating 24x7 at LITE-ON printing conformal electronics onto millions of consumer electronic devices. Since the printing process requires no plating or special resins, logistics are simplified and production costs are lowered. Examples of Aerosol Jet printed sensors and antennas will also be available for inspection. Additionally, on April 26, Dr. James Q. Feng, Principal Engineer at Optomec, will deliver a presentation titled “Aerosol Jet-The Enabling Technology for 3D Printed Electronics.” Dr. Feng will explain how Aerosol Jet technology is used by a wide variety of industries to directly print functional electronic circuitry and components onto low-temperature, non-planar substrates, without the need for masks, screens or plating. Optomec solutions for printed electronics are based on its industry proven Aerosol Jet technology for printing conformal electronic circuitry and components onto 3D structures. The Aerosol Jet process utilizes an innovative aerodynamic focusing technique to collimate a dense mist of material-laden micro droplets into a tightly controlled beam to print features as small as 10 microns or as large as several millimeters in a single pass. A wide assortment of materials can be printed with the Aerosol Jet system, including conductive nano-particle inks, polymers and epoxies, along with dielectrics, ceramics and bio-active materials. For more information on Optomec solutions for 3D printed electronics click here. NEPCON China is a prestigious professional trade platform and exhibition focused on SMT (surface mount technology) and EMA (electronics manufacturing automation). It brings together over 450 renowned brands from the electronics manufacturing industry around the globe with innovative equipment, materials and system integration solutions covering such areas as SMT, electronics manufacturing automation, welding, dispensing, spray coating, testing and measurement. Various technical forums at the venue allow the audience to meet with industry leaders and gain insight into industry trends and technology applications. For more information on the conference, click here. Optomec is a privately held, rapidly growing supplier of Additive Manufacturing systems. Optomec’s patented Aerosol Jet Systems for printed electronics and LENS 3D Printers for metal components are used by industry to reduce product cost and improve performance. Together, these unique printing solutions work with the broadest spectrum of functional materials, ranging from electronic inks to structural metals and even biological matter. Optomec has more than 300 marquee customers around the world, targeting production applications in the Electronics, Energy, Life Sciences and Aerospace industries. LENS (Laser Engineered Net Shaping) is a registered trademark of Sandia National Laboratories. Aerosol Jet and Optomec are registered trademarks of Optomec Inc.
News Article | April 17, 2017
d-Wise Technologies, a leading global technology consultancy and clinical software provider, today announced the availability of a new cloud platform with managed services specifically developed for the biopharmaceutical and contract research industries. The Clinical Acceleration Platform, d-Wise’s latest clinical “as-a-service” cloud solution, is designed to provide rapid deployment of SAS and other software tools, accelerating time to insight and decision-making from a pre-validated, compliant and secure hosted environment. The Clinical Acceleration Platform is the result of close collaboration between SAS and d-Wise and is designed to completely eliminate the regulatory burden associated with clinical systems validation, and accelerate the clinical development lifecycle through improved collaboration, efficient data acquisition, secure data storage, and fast aggregation and analysis. d-Wise, a SAS Gold Partner, is recognized as a leading performer in delivering technology such as SAS Grid Computing and other software products embedded with SAS, including Reveal©, a clinical search tool, and Blur©, the industry-leading clinical trial data de-identification software solution. “The ability to instantly deploy a cloud-based SAS validated environment – and be the first to do this – is very exciting for d-Wise and our clients,” said Tom Dieker, Vice President of Global Client Engagement at d-Wise. “As a trusted SAS Partner, we see this new, instantly available, validated solution as being able to directly address the multitude of challenges faced by biotech, pharma and CROs – particularly the ability to focus on science and not IT deployment, with an ultimate goal of accelerating the drug development cycle.” Data insights are the key to many of the biggest challenges currently facing life sciences organizations. By making SAS’ sophisticated data analytics capabilities available on demand, via a “pay-by-month” or “pay-by-study” cloud delivery model, d-Wise is offering the most streamlined way yet for life sciences organizations – including biotech, pharma and clinical research organisations (CROs) – to turn operational data into actionable intelligence. “We’ve discovered that many SAS customers want quicker solutions but don’t always have the necessary expertise, staffing or budgets to execute,” said Rob Spee, Director of Global Channel Programs at SAS. “d-Wise is a valued Gold Partner who has bundled a much-needed solution that customers require into a turnkey, cloud-based offering that limits the need for additional personnel and lowers risks associated with deploying a new infrastructure. No installation or integration is required, which means they can quickly implement analytic solutions on demand. This results in lower overall IT costs and faster, more substantial ROI.” The instant availability of the Clinical Acceleration Platform will level the playing field, allowing smaller life sciences companies to respond to a range of new industry demands, without having to buy expensive software licences and maintain these internally. d-Wise’s Clinical Acceleration Platform is built on SAS Foundation 9.4 analytics software and includes a suite of best-of-breed clinical software tools and managed services. The platform is highly flexible and scalable, making it potentially available to the widest range of people in any location. The platform is hosted in secure global data centers that meet the highest criteria for resilience, data safeguarding and regulatory compliance. Because it is a validated and compliant environment, organizations will be freed from time-consuming validation processes required by regulatory agencies like the EMA and FDA. d-Wise will introduce the Clinical Acceleration Platform during an upcoming webinar, “How to deploy a secure, compliant, cloud -based SAS clinical computing platform…in 24 hours.” on April 20th at 11:00AM EST. http://www.bio-itworld.com/d-wise-how-to-deploy-a-secure-compliant-cloud/. To learn more about d-Wise please visit http://www.d-wise.com About d-Wise d-Wise Technologies, Inc. http://www.d-wise.com is a technology leader with the expertise to empower world-class life science and healthcare organizations to resolve their business optimization challenges, and help them rapidly harness change by leveraging data, systems and processes to gain competitive advantage. The d-Wise Life Sciences Practice has been providing clinical advisory and modernization services to our clients for over fourteen years. d-Wise consultants engage with life science clients to adopt a progressive and comprehensive approach to modernizing clinical trials through well-designed solutions and processes. d-Wise looks at your systems, processes, architecture, etc. – and identifies those elements that inhibit your ability to achieve your clinical research goals. We then empower you to reach those goals by modernizing your software and solutions, business processes, and infrastructure. We tailor all solutions to meet our individual client needs and deliver the most efficient data integration, data warehousing and standards solutions within highly regulated industries exhibiting domain expertise that’s rooted in knowledge of SAS software, clinical drug development and clinical data standards like CDISC. Our end-to-end expertise and assessment services encompass business process and change management; data and metadata-driven strategies; and vendor-agnostic infrastructure and technology assessments. In healthcare, d-Wise helps organizations develop an analytic vision, and integrate and streamline data operations for rapid deployment of visual intelligence solutions and advanced analytic models. d-Wise is well-known for their expertise and capability to implement advanced analytic solutions and improve operations, lower costs, improve health outcomes quality and facilitate executive decision-making. We have a broad range of experience that includes data optimization for actuarial, quality, medical-management, and operational functions, as well as support for IT and data organizations looking to implement best practices.
News Article | April 24, 2017
Lille (France), Cambridge (Massachusetts, Etats-Unis), le 24 avril 2017 - GENFIT (Euronext : GNFT - ISIN : FR0004163111), société biopharmaceutique engagée dans la découverte et le développement de solutions thérapeutiques et diagnostiques dans le domaine des maladies métaboliques et inflammatoires touchant notamment la sphère hépato-gastroentérologique, a annoncé aujourd'hui sa trésorerie au 31 mars 2017, son chiffre d'affaires pour les trois premiers mois de 2017 et a fait le point des avancées principales de son portefeuille de programme de R&D durant le premier trimestre 2017. Au 31 mars 2017, la trésorerie et les équivalents de trésorerie de la Société s'élevaient à 137,03 millions d'euros (M€) contre 102,8 M€ un an plus tôt. Au 31 décembre 2016, la trésorerie et équivalents de trésorerie totalisaient 152,28 M€. Ce décalage de 4 à 6 mois par rapport au calendrier actuel est en partie dû au nombre croissant d'essais cliniques désormais lancés dans la NASH, mais est surtout lié à la volonté de la Société de s'assurer de la qualité du recrutement, de manière à rendre l'étude clinique la plus robuste possible sur le plan statistique en s'assurant que les ratios liés à la stratification des patients restent au plus près de la réalité médicale. En mars 2017, la Société a affirmé son leadership en lançant une initiative de « disease awareness », The NASH Education Program(TM), qui a suscité une vague d'intérêt sans précédent dans les grands médias francophones. Il s'agit là d'un élément important dans la prise de conscience de tous les acteurs de la maladie. Celle-ci est cruciale dans le cadre d'un recrutement pour une pathologie encore peu connue et asymptomatique comme la NASH. Cette initiative, bien accueillie par un nombre croissant de spécialistes et d'analystes du secteur, sera donc logiquement étendue à d'autres pays. Le but est de traiter le plus grand nombre de patients NASH, et si possible réduire les doses. La méthode de scoring résulte quant à elle de la mise au point d'un nouvel algorithme basé sur un nombre réduit de variables, générant un score performant en matière d'AUROC (Area Under the Receiver Operating Curve), de sensibilité, de spécificité, de NPV (Negative Predictive Value) et de PPV (Positive Predictive Value). Les deux présentations/posters ont confirmé le potentiel de l'approche développée par la Société, et sa capacité à apporter une solution diagnostique IVD basée sur une prise de sang, qui serait à la fois non invasive, facile d'accès, à moindre coût et donc à large diffusion, notamment par rapport à d'autres approches existantes ou encore en cours de développement. Si ces autres approches telles que l'imagerie ou encore l'élastographie sont complémentaires, elles nécessitent en effet des investissements en équipement et formation significatifs, et ne sauraient donc en aucun cas remplacer un outil IVD à très large diffusion. Dans le cadre d'un projet ambitieux visant à élargir et à diversifier son portefeuille de candidats médicaments propriétaires destinés à traiter les maladies auto-immunes, inflammatoires et fibrotiques, la Société s'est investi ces trois dernières années dans le design et dans l'optimisation de différentes séries chimiques d'agonistes inverses de RORgt. Outre les points portés classiquement à l'ordre du jour de cette assemblée générale mixte (examen du rapport de gestion et des comptes annuels de l'exercice 2016, des rapports généraux et spéciaux du Directoire et des commissaires aux comptes, des délégations de compétence en matière d'augmentations de capital, .), le Directoire proposera de transformer la structure de gouvernance actuelle de la Société (à Conseil de Surveillance et Directoire) en structure moniste (à Conseil d'Administration) et de se mettre en conformité avec la loi dite « Copé-Zimmermann » (relative à la représentation équilibrée des femmes et des hommes au sein des conseils) Toutes ces avancées font que la Société grandit et s'internationalise à mesure que nos produits se développent. Souhaitant à la fois traduire cette évolution et nous donner les moyens de l'accompagner au niveau de la gouvernance de la Société, nous allons proposer à notre prochaine assemblée générale de transformer la structure de gouvernance duale actuelle de la SA GENFIT (à Conseil de Surveillance et Directoire) en structure moniste à Conseil d'Administration. Cette dernière nous paraît en effet plus proche des standards internationaux et par conséquent plus à même de nous permettre d'accueillir les administrateurs experts que nous souhaitons progressivement recruter pour accompagner le développement de la Société dans les années à venir. Si ce projet de changement obtient l'assentiment de nos actionnaires, je serais bien entendu très heureux de présider aux destinées de ce nouveau conseil tout en continuant d'assurer la Direction Générale de la Société. » Elafibranor est le composé le plus avancé du portefeuille de GENFIT. Elafibranor est un traitement de type « first-in-class », Agoniste du Récepteur Activé par les Proliférateurs des Peroxysomes alpha et delta, administré une fois par jour par voie orale, et développé pour traiter notamment la stéatohépatite non-alcoolique (NASH). Elafibranor est considéré comme capable de traiter les multiples facettes de la NASH telles que l'inflammation, la sensibilité à l'insuline, les profils lipidique et métabolique, les marqueurs du foie. GENFIT est une société biopharmaceutique dédiée à la découverte et au développement de médicaments dans des domaines thérapeutiques où les besoins médicaux sont considérables en raison du manque de traitements efficaces et du fait de l'augmentation du nombre de malades au niveau mondial. GENFIT concentre ses efforts de R&D pour participer à la mise sur le marché de solutions thérapeutiques visant à combattre certaines maladies métaboliques, inflammatoires, autoimmunes ou fibrotiques touchant en particulier le foie (comme la stéatohépatite non alcoolique ou NASH) et plus généralement la sphère gastro-intestinale. GENFIT déploie des approches combinant nouveaux traitements et biomarqueurs. Elafibranor, composé propriétaire de GENFIT le plus avancé, est en cours de phase 3 d'essais cliniques. Installée à Lille, Paris et Cambridge, MA (USA), l'entreprise compte environ 130 collaborateurs. GENFIT est une société cotée sur le marché réglementé d'Euronext à Paris, Compartiment B (Euronext : GNFT - ISIN : FR0004163111). www.genfit.fr Ce communiqué de presse contient des déclarations prospectives. Bien que la Société considère que ses projections sont basées sur des hypothèses raisonnables, ces déclarations prospectives peuvent être remises en cause par un certain nombre d'aléas et d'incertitudes, ce qui pourrait donner lieu à des résultats substantiellement différents de ceux décrits, induits ou anticipés dans lesdites déclarations prospectives. Ces aléas et incertitudes comprennent notamment les incertitudes inhérentes à la recherche et développement, y compris dans le domaine des biomarqueurs, au progrès et aux résultats de l'essai clinique RESOLVE-IT, aux examens et autorisations d'autorités réglementaires comme la FDA et l'EMA concernant notamment elafibranor dans la NASH, la CBP et d'autres indications, ainsi que les biomarqueurs développés par la Société, au succès d'une stratégie d'in-licensing, à la capacité de la Société à continuer à lever des fonds pour son développement, ainsi qu'à ceux développés à la section 7 «Principaux Risques et incertitudes» du Rapport d'Activité et Financier semestriel au 30 juin 2016 disponible sur le site Internet de GENFIT (www.genfit.fr) et de l'AMF (www.amf-france.org). Sous réserve de la réglementation applicable, la Société ne prend aucun engagement de mise à jour ou de révision des informations contenues dans ce communiqué.
News Article | April 21, 2017
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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News Article | May 2, 2017
Camurus (NASDAQ STO: CAMX) and Braeburn Pharmaceuticals today announced positive top-line results from a long-term Phase 3 trial supporting the safety and efficacy of CAM2038 (weekly and monthly buprenorphine depots) in patients with moderate-to-severe opioid use disorder. "These new Phase 3 results add to the growing body of evidence supporting the use of our weekly and monthly buprenorphine depots (CAM2038) as a flexible, individualized therapy for patients with opioid use disorder," said Fredrik Tiberg, President & CEO, Camurus. "The present long-term study confirms the safety profile and efficacy of CAM2038 in both new-to-treatment patients and patients on maintenance treatment with daily buprenorphine. The results further strengthen our upcoming regulatory submissions to EMA and FDA in mid-2017." "People living with opioid use disorder need additional therapies that can provide meaningful improvement of treatment outcomes and quality of life. It is particularly important that we reduce the stigma and burdens associated with existing treatment approaches that require daily use of medications," said Prof. Nicholas Lintzeris, MBBS, PhD, FAChAM, Conjoint Professor of Addiction Medicine, University of Sydney, Australia. "We are pleased with the study treatments and results of this Phase 3 long-term safety study, showing that these buprenorphine depots were well-tolerated by patients and provided high levels of efficacy across the 48-week treatment period." A total of 228 patients were enrolled in the study conducted at 29 sites across the U.S., Europe and Australia. 162 (71 %) patients completed the 48-week study treatment period. The safety profile of CAM2038 was similar to that observed in previous shorter term trials. A total of 17 (7%) serious adverse events were reported in this 48-week study (52 weeks including follow-up), of which none was considered related to the study medication. Importantly, as in the previous Phase 3 efficacy study, no opioid overdoses were reported for patients treated with CAM2038 depot injections. Overall, headache, nausea, vomiting, nasopharyngitis, and urinary tract infection were the most common adverse events; in each case reported by less than 10% of patients. Injection site reactions occurred in 20% of the participants and were generally mild (16.3%) or moderate (3.5%). Severe injection site pain was reported for one patient (0.4%). Notably, more than 5000 injections of CAM2038 were administered in the study. Efficacy was assessed by weekly and monthly urine toxicology tests. On average, 75% of the urine samples were negative for illicit opioids across the 48-week treatment period. "The positive results from this study, coupled with the earlier reported positive results from the pivotal Phase 3 efficacy trial, enable our teams to finalize regulatory submissions seeking approval in the U.S., Europe and other key global markets," said Behshad Sheldon, President and CEO of Braeburn Pharmaceuticals. "Opioid addiction is an overwhelming public health epidemic. In the U.S. alone, there are 2.6 million patients diagnosed with opioid addiction, and approximately 30,000 people die every year from opioid overdoses. We look forward to bringing these innovative options of weekly and monthly buprenorphine medicines to patients as quickly as possible." "The successful completion of this study marks an important step forward in the development of provider-administered depot medications for the treatment of opioid use disorder," noted Michael Frost, MD, medical director, Eagleville Hospital and President of Frost Medical in Philadelphia, and the coordinating investigator for the study. "Having both weekly and monthly formulations as well as multiple dosage strengths available, allows the treatment to be tailored to the individual needs of patients. Those who participated in the study tolerated the treatment well whether they were transitioned from other forms of buprenorphine or were new entrants to treatment." For more information about CAM2038 and the Phase 3 trial, please see the full press release at http://www.camurus.com. This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Swedish Securities Markets Act. The information was submitted for publication, through the agency of the chief executive officer, 08.00 AM CET on 2 May 2017.
News Article | April 18, 2017
Dr. Porter was most recently Chief Medical Officer of Dance BioPharm, focused on the development of inhaled insulin products to treat diabetes. Previously, she was Vice President, Medical Development of Amylin Pharmaceuticals where she led the R&D efforts for the Amylin-Lilly Alliance culminating in the approval of the GLP-1 agonist Bydureon (exenatide extended release), the first once weekly treatment for Type 2 diabetes. Earlier, Dr. Porter held positions of increasing leadership at GlaxoSmithKline, where she was responsible for clinical strategy for Avandia (rosiglitazone) for Type 2 diabetes. Dr. Porter earned a B.S. in Biology from William & Mary, an M.D. from Duke University, and completed her fellowship in Endocrinology and Hypertension at Brigham and Women's Hospital. "Eiger and Stanford have made amazing progress across multiple clinical studies in which exendin 9-39 was shown to prevent and reduce symptoms of hypoglycemia in post-bariatric surgical patients during an oral glucose tolerance test (OGTT), and I'm very encouraged by the results," said Lisa Porter, M.D. "Exendin 9-39 represents the first potential targeted therapy for patients suffering from PBH, a significant unmet medical need. I'm excited to join the team and lead this program moving forward." Eiger is developing a proprietary, novel liquid formulation of exendin 9-39 which in dog studies has demonstrated a greater than two-fold increase in peak plasma concentrations compared to the original lyophilized powder of exendin 9-39. Development of a liquid formulation of exendin 9-39 represents an opportunity for lower dosing and once on the market, would eliminate the need for patients to dissolve powder in saline, which could be a more convenient product presentation for patients. Eiger is evaluating the new exendin 9-39 liquid formulation in patients in the ongoing MAD study and also in a Phase 1 PK study scheduled for Q2 2017, both of which will inform the next, larger Phase 2 study planned for second half 2017. About Insulin, GLP-1, and Exendin 9-39 Insulin is the principal physiologic hormone secreted to control high blood glucose levels. Abnormal increases in insulin secretion can lead to profound hypoglycemia (low blood sugar), a state that can result in significant morbidities, including seizures, brain damage, and coma. GLP-1 is a gastrointestinal hormone that is released postprandially from the intestinal L-cells. GLP-1 binds to GLP-1 receptors on the beta cells of the pancreas and increases the release of insulin. In patients with PBH, GLP-1-mediated insulin secretion is dysfunctionally exaggerated. Exendin 9-39 is a 31-amino acid peptide that selectively targets and blocks GLP-1 receptors, normalizing insulin secretion by the pancreas, and thereby reducing postprandial hypoglycemia. Exendin 9-39 is being investigated as a novel treatment for PBH. Exendin 9-39 has been granted orphan designation in the European Union by the EMA for the treatment of non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS) and orphan designation in the United States by the FDA for the treatment of hyperinsulinemic hypoglycemia. Both of these broad designations include PBH. A therapy that safely and effectively mitigates insulin-induced hypoglycemia has the potential to address a significant unmet therapeutic need for certain rare medical conditions associated with hyperinsulinism. Exendin 9-39 has never been approved or commercialized for any indication. The long-term efficacy and safety of subcutaneous (SC) injected exendin 9-39 have not yet been established. More information on exendin 9-39 clinical trials may be found at www.clinicaltrials.gov. About Post-Bariatric Hypoglycemia (PBH) Approximately 150,000-200,000 bariatric surgical procedures are performed each year in the United States, and another 100,000 are performed each year in Europe. The estimated prevalence of PBH is approximately 30,000 in the United States and approximately 25,000 in the European Union. As the number of bariatric surgeries to treat obesity and related comorbidities has increased, so too has the number of individuals who experience PBH, with symptoms typically developing 12 to 18 months following surgery. PBH can occur with a range of severity in post-bariatric surgery patients. Mild to moderate hypoglycemia may be managed largely through dietary carbohydrate restriction, whereas severe hypoglycemia results in neuroglycopenic outcomes (altered mental status, loss of consciousness, seizures, coma) which are unresponsive to diet modification. Severe PBH can be debilitating with a significant negative impact on quality of life. There is no approved pharmacologic therapy. About Eiger Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is identified, and for which an effective therapy is urgently needed. For more information, please visit the Company's website at www.eigerbio.com. Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, whether or not pegylated interferon lambda-1a, lonafarnib, ubenimex or exendin 9-39, including SC formulation, may be further developed and approved, whether Phase 1 and Phase 2 studies of exendin 9-39 will show safety and activity consistent with early clinical results, including the interim results of the MAD study, or that the new liquid formulation will be consistent with results seen with IV and SC formulations of exendin 9-39, statements relating to the availability of cash for Eiger's future operations, Eiger's ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Annual Report on Form 10-K for the period ended December 31, 2016 and our periodic reports filed with the Securities and Exchange Commission. Eiger assumes no obligation to update any forward-looking statements, except as required by law. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eiger-announces-industry-veteran-lisa-porter-md-to-lead-development-of-exendin-9-39-for-the-treatment-of-post-bariatric-hypoglycemia-300440724.html
News Article | April 18, 2017
«Nos dimos cuenta al principio que apoyar un identificador común y robusto a través de nuestras cadenas de suministro, en armonía con la norma específica del sector EMA Avails, nos permitiría realizar un gran ahorro debido a su eficiencia. Además, una mejora de la automatización mejoraría el plazo de lanzamiento de los activos de entretenimiento de nuestros proveedores de contenidos asociados», afirmó Bill Kotzman, Director de Asociados/Productos de YouTube/Google, y miembro del consejo de EIDR. «Y ahora, EIDR es una parte integrante de la automatización de los informes financieros para nosotros y para nuestros proveedores de contenidos asociados». Este anuncio es un hito importante en el esfuerzo concertado entre Google Play y los proveedores de contenidos, incluyendo a los grandes estudios de Hollywood, también ellos miembros titulares de EIDR. «El viaje de ida y vuelta» de EIDR proporciona las muy esperadas eficiencias en la cadena de suministro digital, que da como resultado unas revolucionarias mejoras sistémicas en la redacción de informes financieros y capacidades de facturación para todo el sector»," dice Kelly Fong-Bouchey, Director, Relaciones con el Cliente y Operaciones, Warner Bros. Technology. «El equipo de Warner Bros. Technology está entusiasmado porque Google, un socio de distribución digital clave, ha adoptado e integrado el «viaje de ida y vuelta» de EIDR en su flujo de trabajo." «Sony Pictures Entertainment ha adoptado el EIDR en la totalidad de sus sistemas de datos y, más recientemente, como la clave de la automatización de la cadena de suministro digital transaccional», afirmó Ellen Goodridge, SVP Cadena de Suministro Digital y Desarrollo de Productos, Sony Pictures Home Entertainment. «La finalización del «viaje de ida y vuelta» de EIDR con Google Play representa una oportunidad para ampliar la automatización basada en estándares que incrementará la eficiencia en el negocio digital premium». «Disney está muy satisfecho de ver el progreso que EIDR ha realizado en su capacidad de impulsar eficiencias a través de flujos de trabajo automatizados basados en estándares a lo largo y ancho de su cadena de suministro digital integrada», dice Christopher Stefanidis, Vicepresidente, Operaciones y Estrategia de Distribución Digital, Walt Disney Pictures and Television. «Lograr este hito inicial sobre el «viaje de ida y vuelta» supone un paso importante y esperamos establecer muchos otros usos específicos para EIDR y nuestros asociados del sector». Acerca de EIDR: EIDR (Registro Identificador de Entretenimiento) es un sistema de identificación universal para activos filmográficos y televisivos. Desde títulos de alto nivel, ediciones y DVD a codificaciones, clips y «mash-ups», EIDR proporciona identificadores altamente depurados, únicos a nivel mundial, para la totalidad de la gama de tipos de objeto audiovisual relevantes para el comercio del entretenimiento. Para más información sobre EIDR, visite eidr.org.
News Article | June 6, 2017
Enterprise Management Associates (EMA), a leading IT and data management research and consulting firm, today announced it will host a research webinar titled “Next-Generation IT Service Management—Changing the Future of IT: How Real Is It Today, and Where is It Going in the Future?,” featuring Dennis Drogseth, VP of research covering IT megatrends, snalytics and CMDB dystems at EMA. In ongoing research and interviews, EMA has witnessed the growing role of IT service management in many IT organizations. This growth is a result of progressive ITSM teams—with integrated capabilities to support asset management, operations, development and the IT executive and business community—becoming a hub in optimizing IT for both value and cost. During this webinar, Drogseth will provide insight into this new research, with some dramatic, and telling revelations. Some of the questions addressed will be: The webinar is Thursday, June 15 at 2:00 p.m. Eastern. Those who wish to attend can register at: http://research.enterprisemanagement.com/next-gen-itsm-2017-webinar-pr.html About EMA Founded in 1996, EMA is a leading industry analyst firm that specializes in providing deep insight across the full spectrum of IT and data management technologies. EMA analysts leverage a unique combination of practical experience, insight into industry best practices, and in-depth knowledge of current and planned vendor solutions to help clients achieve their goals. Learn more about EMA research, analysis, and consulting services for enterprise line of business users, IT professionals and IT vendors at http://www.enterprisemanagement.com or blogs.enterprisemanagement.com.
News Article | June 14, 2017
Enterprise Management Associates (EMA™), a leading IT and data management research and consulting firm, has released a new research report titled “Next-Generation IT Service Management: Changing the Future of IT,” based on criteria defined by Dennis Drogseth, vice president of research at EMA. While IT service management (ITSM) has too often been viewed by the industry as an area of reactive management with fading process efficiencies and legacy concerns, this new study reveals that, in many organizations, ITSM is becoming a hub of innovation. ITSM is shown to unify IT across its many silos, promote and measure IT operational efficiencies, and consolidate insights critical for IT-to-business planning. This evolution, however, is not without its obstacles and challenges, nor is it taking place in all IT organizations. In this report, ITSM is examined from various perspectives, including organizational role of respondents, company size and vertical, geographical differences, and success-related patterns of behavior. Targeted at IT executives and technical adopters across not only ITSM teams but also operations, development and IT asset management (ITAM) teams, this report shows what is really occurring with ITSM initiatives in both North America and Europe and provides a blueprint for how best to accelerate forward into a next-generation status. “The catalytic role of ITSM teams both across IT, and in support of enterprise efficiencies, is still largely misunderstood by many in the industry,” said Drogseth. “This research spotlights ITSM team centricity in everything from IT asset management and enterprise process automation, to increasing support for agile and DevOps initiatives, integrated IT operations, and being a center for IT governance overall—just to name a few examples. This extended outreach means reassessing ITSM in terms of relevant stakeholders, processes, best practices and needed technologies, all of which is examined in our report.” A few of the key data points from this survey are: A detailed analysis of the research findings are available in the report, "Next-Generation IT Service Management: Changing the Future of IT." Key highlights from the research are available in the “Next-Generation IT Service Management: Changing the Future of IT” webinar. About EMA Founded in 1996, EMA is a leading industry analyst firm that provides deep insight across the full spectrum of IT and data management technologies. EMA analysts leverage a unique combination of practical experience, insight into industry best practices, and in-depth knowledge of current and planned vendor solutions to help its clients achieve their goals. Learn more about EMA research, analysis, and consulting services for enterprise line of business users, IT professionals, and IT vendors at http://www.enterprisemanagement.com or blogs.enterprisemanagement.com.
News Article | June 22, 2017
NEW YORK--(BUSINESS WIRE)--EasyVista Inc., a leading provider of service management for IT organizations, announced that key findings from EMA’s Next Generation IT Service Management: Changing the Future of IT report (co-sponsored by EasyVista) mirrors EasyVista’s own belief that the service desk is assuming an increasingly strategic role in the enterprise. It also supports EasyVista’s thesis that excellent user experience and simple, intuitive self-service are essential to achieving wide adoption among users. EMA, a leading IT and data management research and consulting firm, surveyed 264 companies across North America and Europe on a range of subjects related to ITSM. They found that the industry is breaking away from its reputation as outdated, reactive and inefficient to become a focal point for innovation. “In many organizations, ITSM is becoming a hub of innovation unifying IT across its many silos. ITSM promotes and measures IT efficiencies, consolidating insights critical for IT-to-business planning—a must for digital transformation and IT more broadly,” said Dennis Drogseth, Vice President of EMA and author of the research. “We’re excited to see EMA’s validation of what we are also seeing in the market,” said Jamal Labed, COO of EasyVista. “There is a palpable shift in the way companies view the role of ITSM. The service desk has expanded well beyond traditional IT support to become a destination for all kinds of services, many of which are based entirely on self-service. EasyVista customers are perfectly positioned to transform their service desk into a center of innovation.” Many of EMA’s research findings pointed to end user experience being a top priority. In particular: “The number of responses to varied questions that all pointed to user experience as the Holy Grail was striking,” said Drogseth. “While improving end user experience received the most responses as the strategic priority, the combined choice of mobility, self-service and intelligent bots—all core to user experience—appeared equally high on priorities. Furthermore, social IT, another core function enabling user experience, was listed as the most important functional capability by respondents.” “User experience is not simply about making things easy, it’s about creating an end-to-end experience that resembles what users have grown accustomed to in their lives outside of work—an experience that is second nature and requires no training,” said Labed. “This isn’t, however, going to be solved with just one technology. Instead, a mixture of support for mobility, social collaboration, intelligent bots and self-service is required to deliver the seamless user experience expected by today’s business users.” To download EMA’s report, please click here. EasyVista simplifies IT Service Management by making it easy to deliver and easy to use for today’s enterprise. EasyVista’s service management platform was created to help companies automate and personalize service delivery to improve IT efficiency and increase staff productivity. Today, EasyVista helps 1,000+ enterprises around the world radically improve service user experience, dramatically simplify and accelerate service creation, and reduce the total cost of IT service delivery. EasyVista serves companies across a variety of industries, including financial services, healthcare, higher education, technology, public sector, retail, manufacturing and more. Headquartered in New York and Paris, EasyVista is a rapidly growing global company backed by leading venture capitalists, and traded as ALEZV:EN. Founded in 1996, EMA is a leading industry analyst firm that specializes in providing deep insight across the full spectrum of IT and data management technologies. EMA analysts leverage a unique combination of practical experience, insight into industry best practices, and in-depth knowledge of current and planned vendor solutions to help clients achieve their goals. Learn more about EMA research, analysis, and consulting services for enterprise line of business users, IT professionals and IT vendors at http://www.enterprisemanagement.com or blogs.enterprisemanagement.com. You can also follow EMA on LinkedIn, Twitter and Facebook.