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The present invention provides topical ophthalmic formulations comprising a combination of one or more antihistamine agents and optionally one or more vasculature modifying agents such as a adrenergic receptor antagonist. Also provided are methods of using the formulations of the invention for treating and/or preventing symptoms associated with migraine headache, and for reducing the frequency, severity and duration of migraine attacks.


News Article | May 17, 2017
Site: www.businesswire.com

CHICAGO--(BUSINESS WIRE)--The Escape Pod Group, an independent, full-service ad agency collective, today announced that it has named veteran marketing executive Celia Jones Brand Director. In this role, she will be responsible for amplifying the agency brand and managing PR and marketing initiatives across the group’s three partner agencies: The Escape Pod, digital agency ORA Interactive, and experiential agency OutCold. “Celia brings a mix of strategic thinking and proven experience helping brands and agencies carve out their unique position in the marketplace. The Escape Pod has grown significantly over the past 10 years. Given our recent strategic acquisitions we can provide clients with true full-service capabilities, while still moving faster and more cost-effectively than larger shops. Today brands need a nimble strategic partner. That’s a space that we can own, so now is the perfect time for Celia to join our leadership team and help crystallize our story,” said Norm Bilow, Managing Director, The Escape Pod Group. Prior to The Escape Pod Group, Celia held senior marketing roles at various agencies including Rightpoint, one of the nation’s largest privately held digital agencies, and Havas Worldwide Chicago, where she crafted the ad agency’s brand narrative as a creative force and culture catalyst in the industry, and led external marketing, PR, events, awards and internal culture initiatives. Before that, Celia was Global Marketing Director for Critical Mass, where she helped catapult the digital agency from a niche player into a world-class experience design agency. She also served as Director of Content and lead Copywriter at Designkitchen, an interactive marketing and branding agency. “Between the rampant consolidation in our industry and the jargon that so many agencies use to describe themselves, it’s very hard to tell the difference between one agency and the next. It is incredibly refreshing for me to be a part of an organization with such a clear vision of what they stand for. The Escape Pod was founded on an independent spirit and fearless approach to creativity. Innovative brands are hiring us to disrupt long-established categories. And they made key investments to position the agency for the future. It’s an exciting time in our evolution and I’m looking forward to playing a key role in their trajectory,” said Celia Jones, Brand Director, The Escape Pod Group. The Escape Pod Group is a collective of specialty agencies, purpose-built to deliver breakthrough ideas with speed, agility and cost-savings for clients. We combine creative firepower with full-service capabilities across creative, digital, social and experiential marketing. Our mission: amplifying brands across all channels to drive growth. Learn more at www.theescapepodgroup.com.


Spécialiste de la Data et du Digital, acteur leader de la Business Intelligence (analyse des données structurées de l'entreprise) et de la gestion de la relation client (CRM), Business & Decision regroupe 2 500 collaborateurs en France et à l'international, notamment en Europe. A l'issue de la procédure d'information et de consultation des instances représentatives du personnel de Network Related Services (filiale d'Orange) et de Business & Decision, et sous réserve de conditions suspensives usuelles, notamment l'approbation des autorités de la concurrence concernées, l'acquisition serait réalisée en numéraire sur la base d'un prix maximum de 7,93 euros par action. Aujourd'hui, Orange Business Services est déjà leader en matière de transport de données grâce à son savoir-faire réseau, et est fortement positionné sur les domaines de la collecte et de l'hébergement des données. L'acquisition de Business & Decision et son expertise en matière de Business Intelligence et de science des données (Data Science) notamment viendraient renforcer significativement en France et à l'international les activités d'Orange Business Services dans la gouvernance et l'analyse des données. De leur côté, les équipes et clients de Business & Decision bénéficieraient de l'étendue des compétences d'opérateur et d'intégrateur d'Orange Business Services dans les domaines de l'Internet des Objets, du cloud computing, de la cybersécurité et du développement applicatif, ainsi que de l'envergure internationale de son réseau commercial pour accompagner les multinationales partout dans le monde. « Business & Decision et Orange Business Services partagent une vraie culture numérique et un socle d'expertises communes tout en étant très complémentaires en matière d'offres. Nous sommes convaincus que la combinaison de l'expertise de Business & Decision en matière de Data et de Business Intelligence et de notre double savoir-faire d'opérateur et d'intégrateur de services de traitements des données serait un levier clé pour accélérer la transformation digitale de nos entreprises clientes et notre croissance dans ce domaine », déclare Thierry Bonhomme, Directeur Général Adjoint du groupe Orange en charge d'Orange Business Services. « Cette opération correspond parfaitement à la réalisation de nos objectifs stratégiques autour de nos deux offres clés, la Data et le Digital. C'est une opportunité pour Business & Decision et ses équipes de déployer nos expertises sur de nouveaux marchés en France et à l'International et de continuer à investir et innover sur les technologies de la Data. Les valeurs de Business & Decision, chères à son fondateur, et tournées vers le respect des collaborateurs, sont également partagées par Orange, ce qui annonce, j'en suis sûr, un projet réussi », déclare Christophe Dumoulin, dirigeant de Business & Decision. « Je me réjouis que Business & Decision rejoigne un acteur qui partage les valeurs chères à son fondateur Patrick Bensabat dans le respect de l'intérêt de ses collaborateurs et de ses clients. Cette union apportera le nouvel élan dont l'entreprise qu'il a créée a besoin. Les équipes de Business & Decision, pour lesquelles Patrick avait la plus haute estime et la plus grande affection, vont contribuer au succès du groupe Orange en apportant leur expertise et leurs compétences ", déclare enfin Tova Bensabat, membre du Conseil d'Administration et représentante du bloc majoritaire familial. Orange est l'un des principaux opérateurs de télécommunications dans le monde, avec un chiffre d'affaires de 40,9 milliards d'euros en 2016 et 155 000 salariés au 31 décembre 2016, dont 96 000 en France. Présent dans 29 pays, le Groupe servait 263 millions de clients dans le monde au 31 décembre 2016, dont 202 millions de clients mobile et 18 millions de clients haut débit fixe. Orange est également l'un des leaders mondiaux des services de télécommunications aux entreprises multinationales sous la marque Orange Business Services. En mars 2015, le Groupe a présenté son nouveau plan stratégique « Essentiels2020 » qui place l'expérience de ses clients au coeur de sa stratégie, afin que ceux-ci puissent bénéficier pleinement du monde numérique et de la puissance de ses réseaux très haut débit. Orange est coté sur Euronext Paris (symbole ORA) et sur le New York Stock Exchange (symbole ORAN). Pour plus d'informations (sur le web et votre mobile) : www.orange.com, www.orange-business.com ou pour nous suivre sur Twitter : @presseorange. Orange et tout autre produit ou service d'Orange cités dans ce communiqué sont des marques détenues par Orange ou Orange Brand Services Limited. Business & Decision est un Groupe international de consulting et d'intégration de systèmes, leader de la Business Intelligence (BI) et du CRM, acteur majeur de l'e-Business. Le Groupe contribue à la réussite des projets à forte valeur ajoutée des entreprises et accompagne ses clients dans des domaines d'innovation tels que le Big Data et le Digital. Il est reconnu pour son expertise fonctionnelle et technologique par les plus grands éditeurs de logiciels du marché avec lesquels il a noué des partenariats. Fort d'une expertise unique dans ses domaines de spécialisation, Business & Decision offre des solutions adaptées à des secteurs d'activité ainsi qu'à des directions métiers. Présent dans 12 pays, Business & Decision emploie plus de 2 500 personnes en France et dans le monde.         Plus d'informations, sur www.group.businessdecision.com


Not for distribution in the United States of America Orange enters exclusive negotiations to acquire Business & Decision to accelerate Orange Business Services' growth in data intelligence Orange announces that it has entered into exclusive negotiations to acquire a controlling stake of around 67 percent of Business & Decision, a company listed on Euronext Paris, from the majority shareholders - the Bensabat family and Christophe Dumoulin. Specialising in data and digital services, Business & Decision is a leading player in Business Intelligence and CRM (Customer Relationship Management). The company has 2,500 employees in France and internationally, particularly in Europe. The transaction will be finalized following the procedure of informing and consulting the employee representative bodies of both Network Related Services (an Orange subsidiary) and Business & Decision. It is also subject to the usual suspensive conditions, including the approval of the relevant competition authorities. Once these conditions have been met, the operation will be carried out in cash on the basis of a maximum price of 7.93 euros per share. In the event of the successful acquisition of a majority stake, Orange will file a simplified public offer for all Business & Decision shares it does not hold. To do this, and subject to the approval of market authorities, Orange will offer shareholders 7.93 euros per share in cash, which corresponds to the maximum price paid by the majority shareholders. This price of 7.93 euros per share represents a premium of 34 percent compared to the average share price over the previous 12 months. The offer values the entire capital of Business & Decision at approximately 62.5 million euros. Trading was suspended on Monday, 8 May 2017 following market rumours published in the media on Friday, 5 May 2017. This acquisition project is part of Orange Business Services' development strategy, which aims to position it as a global player in digital transformation and as a global leader across the entire data services value-chain. Today, Orange Business Services is already a global leader in secure data transport services thanks to its expertise in network management and is well positioned in data collection and storage. The acquisition of Business & Decision and, in particular, its expertise in Business Intelligence and data science, would significantly strengthen the activities of Orange Business Services in France and internationally in data governance and data analysis. Business & Decision's teams and customers stand to benefit from the breadth of Orange Business Services' capabilities as an operator and integrator in areas such as the internet of things, cloud computing, cybersecurity and application development. They will also benefit from the international scope of the Orange Business Services sales network that supports multinational corporations around the world. "Business & Decision and Orange Business Services share a genuine digital culture based on common skill sets, while offering complementary catalogues of services to their customers. We are convinced that the combination of Business & Decision's expertise in data and Business Intelligence and our dual know-how as an operator and service integrator will be a key lever that will enable us to accelerate the digital transformation of our enterprise customers and stimulate growth," said Thierry Bonhomme, the Orange Group's Deputy CEO in charge of Orange Business Services. "This operation is perfectly in line with the realization of our strategic objectives around our two key offerings: data and digital services. It is an opportunity for Business & Decision and its teams to deploy our expertise in new markets in France and internationally, and to continue to invest and innovate in data-driven technologies. The values of Business & Decision, which are dear to its founder, and that are focused on the respect of its employees, are also shared by Orange, and I am convinced that this is an excellent indicator of the future success of this project," said Christophe Dumoulin, Managing Director of Business & Decision. "I am extremely happy that Business & Decision is joining a group that shares the same values as the company's founder Patrick Bensabat with regards to assuring the best interests of the company's employees and customers. This union will bring the fresh dynamic which the company that he created now needs to move forward. Business & Decision's teams, that Patrick had cherished with enormous esteem and affection, will now contribute to the success of the Orange Group by bringing their expertise and operational efficiency," said Tova Bensabat, Board member and representative of the family-held majority ownership. The transaction is expected to be completed by the end of the third quarter of 2017. Orange is one of the world's leading telecommunications operators with sales of 40,9 billion euros in 2016 and 154,000 employees worldwide at 31 March 2017, including 95,000 employees in France. Present in 29 countries, the Group has a total customer base of 265 million customers worldwide at 31 March 2017, including 203 million mobile customers and 19 million fixed broadband customers. Orange is also a leading provider of global IT and telecommunication services to multinational companies, under the brand Orange Business Services. In March 2015, the Group presented its new strategic plan "Essentials2020" which places customer experience at the heart of its strategy with the aim of allowing them to benefit fully from the digital universe and the power of its new generation networks. Orange is listed on Euronext Paris (symbol ORA) and on the New York Stock Exchange (symbol ORAN). For more information on the internet and on your mobile: www.orange.com, www.orange-business.com or to follow us on Twitter: @orangegrouppr. Orange and any other Orange product or service names included in this material are trademarks of Orange or Orange Brand Services Limited. About Business & Decision Business & Decision, a global consulting and systems integration group (CSI), is a leader in Business Intelligence (BI) and CRM, and is a leading e-Business player. The Group contributes to the success of high added-value projects for businesses and supports its customers in various innovative areas such as Big Data and digital services. The company is recognized for its operational and technical expertise by leading software developers with whom it has built-up solid partnerships. With its unique capabilities in its specialist areas, Business & Decision offers tailored solutions for a broad range of sectors and industry functions. Business & Decision operates in 12 countries and employs more than 2,500 people in France and around the world.


ROAD TOWN, BRITISH VIRGIN ISLANDS--(Marketwired - May 29, 2017) - Aura Minerals Inc. (TSX: ORA) announces the results of the votes held at the Annual General and Special Meeting of Shareholders (the "Meeting") held in Road Town, Tortola, British Virgin Islands. The Company announces the retirement of Patrick Mars from the Company's Board of Directors. Patrick joined the Company as a Director in 2006 and he served as the Chairman of the Board from 2008 to 2016 and held positions on several Board committees, including Chairman of the Audit Committee. Patrick was instrumental in the purchases of the San Andres, Sao Francisco and Sao Vincente mine acquisitions that turned the Company into a producer. Jim Bannantine, did not stand for re-election due to personal reasons but noted that his decision did not have anything to do with his view of the Company or that it will affect his shareholdings in the Company. The Company would like to extend their warmest thanks to Jim for steering the Company through a difficult time in the market with declining commodity prices and his restructuring initiatives to reduce costs. The Company also announces that due to personal reasons of outside employment, Juarez Saliba did not stand for re-election at the Meeting. Rodrigo Barbosa, the Company's President & CEO stated, "On behalf of management and the Board of Directors, we express our sincere appreciation for Patrick's and Jim's many years of service and for the year of service from Juarez. It has been a rewarding experience working with all of them during my tenure at the Company and we wish them continued success." For additional details on these matters, please see the Management Information Circular of the Company dated April 25, 2017 and the Company's amendment dated May 2, 2017 (together, the "Information Circular").


This seminar on veterinary medicine regulations will provide attendees with a comprehensive understanding of FDA's veterinary drug approval process. The U.S. Food and Drug Administration's Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. FDA regulates not all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture's Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency. This two day interactive course will cover: - Premarket approval process - Various sections of a New Animal Drug Application - Strategies for navigating the FDA approval process and for expending product approval - The nature of shared jurisdiction over veterinary products in certain cases. - Understand how the U.S. Food and Drug Administration regulates veterinary drug product. - Understand how FDA's Center for Veterinary Medicine is organized. - Discuss the process by which veterinary drug products are reviewed and approved. - Learn how to open an INAD File and request fee waivers. - Obtain a working knowledge of various sections included within an NADA. - Develop a deep understanding of what is needed to substantiate product characterization, target safety and effectiveness. - Analyze FDA's rules governing chemistry, manufacturing and controls or CMC. - Understand the various components of an animal field study to support product approval. - Discuss the difference between FDA's various user fees and fee waivers. - Identify the elements of an FDA compliant label. - Develop a corporate compliance strategy covering labeling, marketing and advertising. - Problem solving methods to mitigate regulatory enforcement risks. - Explain how jurisdiction is split between various Federal agencies in a certain cases. - Learn how animal feed, veterinary devices, OTC drug products and nutritional supplement are regulated in the U.S. Introduction to Veterinary Drug Approval process - FDA's jurisdiction and Center's relevant to Animal Health - Center for Food Safety and Applied Nutrition (CFSAN) - Center for Drug Evaluation and Research (CDER) - Center for Veterinary Medicine (CVM) - Specifics of CVM - Intro to the FDCA, AMDUCA, ADAA, MUMS, etc and guidance (GFI) - Overview of FDCA and regulations - Introduction to FDA GFI Overview of Veterinary Drug Development Discovery/Acquisition - Preliminary Patent Protection Concerns Submissions - Open INAD File - NADA (8 sections) - 5 Major Technical Sections - Chemistry, Manufacturing and Controls (CMC) - Safety (target animal safety study) - Efficacy (field study) - Human Food Safety (human food safety studies for food-producing animals) - Environmental Impact (EA/CE) - 3 Minor Technical Sections - All other information - Labeling - Freedom of Information Summary (FOI) Brief Description of cGxP (GMP, GLP, &GCP) CMC - API: name, structure, properties - API manufacturing - Clinical Trial material - Final Formulation Target Animal Safety - Content and format - Final Study Reports - Monitoring and Reporting Adverse Drug Events Human Food Safety - Analysis of Drug Residues - Toxicology - Residue Chemistry - Microbial Food Safety - Regulatory Method Relied Upon by Sponsor Effectiveness - Dosage Characterization - Substantial evidence (e.g. dose confirmation and clinical field studies) - All other information related to effectiveness - Proposed effectiveness-related labelling - Effectiveness Guidance Documents - The 7 Major Phases of Animal Field Studies - Planning - Study Initiation - In-life Activities - Site close-out - Data management - Biostatistical analysis - Report Writing Approval Process: Chemistry, Manufacturing Controls, Environmental Impact & Managing Clinical Trials - Environmental Impact - Categorical Exclusions - Environmental Assessments (EA) - Common EA Components - Environmental Impact Statements (EIS) - Labeling - FOI - AOI Animal Drug User Fees and Related Fee Waivers - Veterinary Drug User Fees and Fee Reductions and Waivers - Animal Drug User Fee Act (ADUFA) - Applies to Innovators Only - Animal Generic Drug User Fee Act (ADGUF) - Applies to Generic Manufacturers - ANADA sections - CMC - BE (Safety & Efficacy) - HFS - All others - Types of User Fees - Animal Drug Application and Supplement Fee - Animal Drug Product Fee - Animal Establishment Fee - Animal Drug Sponsor fee - Types of Fee Waivers and Reductions - Procedures, Timing and FDA Evaluation of Waivers or Reductions - FDA decision on approval Introduction to FDA's Regulation of Veterinary Feed, OTC Drugs and Supplements - Animal Feed - GRAS - Feed Labeling - AAFCO - Veterinary Feed Directive (VFD) - Veterinary OTC Drugs and Nutritional Supplements - Regulatory Agencies - CVM Compliance Policy - CPG 690.150 & CPG 690.100 - Veterinary Medical Devices CPG 655.100 USDA (CVB, APHIS, FSIS) & EPA - USDA's Animal and Plant Health Inspection Service - Virus Serum Toxin Act - Animal vaccines - Animal biologics - Animal disease diagnostic devices - EPA - Flea & Tick Products - Insect Repellants such as Equine Fly Sprays - State Registrations Non-Approval-Related Considerations - Extra-Label Drug Use - Compounding - Noncompliance and Enforcement - FDA Enforcement Authority over Development, Manufacture, Marketing, and Distribution - FDA's Office of Regulatory Affairs (ORA): Responsible for field activities, imports, inspections, and enforcement policy - Local, State, and Tribal governments - CVM's Office of Surveillance and Compliance - Types of Enforcement Actions Importance of Patent Protection: Right to Enforce For more information about this conference visit http://www.researchandmarkets.com/research/h6p6wc/the_veterinary To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/two-day-veterinary-drug-approval-process-and-fda-regulatory-oversight-course-kansas-city-missouri-united-states---june-13-14-2017---research-and-markets-300444055.html


Gomes P.J.,ORA Inc
Current Opinion in Allergy and Clinical Immunology | Year: 2014

Purpose of review: This review describes recent findings and trends in prevalence and treatment of allergic ocular diseases. Although the major focus is on seasonal and perennial allergic conjunctivitis, related disorders will also be considered. Recent findings: Published reports from countries around the world suggest that the spectrum of atopic diseases, including seasonal and perennial allergic conjunctivitis, is continuing its pattern of increasing prevalence, which has been well documented over the past few decades. In addition, although treatment modalities have focused on topical formulations including antihistamines and corticosteroids, there is a significant emphasis on immunotherapy as an alternative treatment modality, particularly in the USA. Summary: Allergic conjunctivitis is a key component in the spectrum of allergic diseases that is sometimes collectively referred to as rhinoconjunctivitis. Because of its high prevalence worldwide, it exacts an increasing toll in terms of patient discomfort, morbidity, and loss of productivity. Current estimates suggest that at least 20% of the overall population suffers from some form of allergic conjunctivitis, many without ever seeking treatments. In addition, a significant proportion of patients experience chronic forms of allergy that are less responsive to existing therapies. Recent approval of immunotherapy-based treatments may address this therapeutic gap. © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Patent
ORA Inc | Date: 2011-08-15

This is directed to systems, processes, machines, and other means that simulate blast waves from explosive events. The invention can make waveforms tailored to a users preference to accurately model a variety of explosive events by utilizing a driver section and a transition section that have divergent geometries.


Patent
ORA Inc | Date: 2015-09-29

Disclosed herein are systems, methods, and machine readable media for visualizing complex data, including real-time data streams from wearable device sensors, using a halo-based representation. Halos are comprised of multiple rings that can be used to efficiently convey, for example, information about the status of a subject, such as a subjects heart rate, activity level, and calories burned at particular times throughout a day.


The present invention provides topical ophthalmic formulations comprising a combination of one or more antihistamine agents and optionally one or more vasculature modifying agents such as a adrenergic receptor antagonist. Also provided are methods of using the formulations of the invention for treating and/or preventing symptoms associated with migraine headache, and for reducing the frequency, severity and duration of migraine attacks.

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