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In Re Cipro Cases I And Ii
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Download or read book Drug-Induced Liver Injury written by and published by Academic Press. This book was released on 2019-07-13 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug-Induced Liver Injury, Volume 85, the newest volume in the Advances in Pharmacology series, presents a variety of chapters from the best authors in the field. Chapters in this new release include Cell death mechanisms in DILI, Mitochondria in DILI, Primary hepatocytes and their cultures for the testing of drug-induced liver injury, MetaHeps an alternate approach to identify IDILI, Autophagy and DILI, Biomarkers and DILI, Regeneration and DILI, Drug-induced liver injury in obesity and nonalcoholic fatty liver disease, Mechanisms of Idiosyncratic Drug-Induced Liver Injury, the Evaluation and Treatment of Acetaminophen Toxicity, and much more. - Includes the authority and expertise of leading contributors in pharmacology - Presents the latest release in the Advances in Pharmacology series
Book Synopsis EU Law of Competition and Trade in the Pharmaceutical Sector by : Pablo Figueroa
Download or read book EU Law of Competition and Trade in the Pharmaceutical Sector written by Pablo Figueroa and published by Edward Elgar Publishing. This book was released on 2019 with total page 733 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
Book Synopsis Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law by : Amalia Athanasiadou
Download or read book Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law written by Amalia Athanasiadou and published by Kluwer Law International B.V.. This book was released on 2018-08-14 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reverse payment settlements or “pay-for-delay agreements” between originators and generic drug manufacturers create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals and also the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals. This book is one of the first to critically and comparatively analyse how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by both United States (US) and European courts and enforcement authorities, and to discuss the applicable legal tests and the main criteria used for their assessment. The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and European Union (EU) competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including: – the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavisand subsequent jurisprudence; – the decision of Lundbeck v. Commissionby the European General Court and the Servier decision of the European Commission; – the Roche/Novartisdecision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU; – an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals, mechanisms affecting generic substitution; – the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests; – the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law. The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant caselaw, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.
Book Synopsis IP and Antitrust: An Analysis of Antitrust Principles Applied to Intellectual Property Law, 3rd Edition by : Hovenkamp, Janis, Lemley, Leslie, Carrier
Download or read book IP and Antitrust: An Analysis of Antitrust Principles Applied to Intellectual Property Law, 3rd Edition written by Hovenkamp, Janis, Lemley, Leslie, Carrier and published by Wolters Kluwer. This book was released on 2016-01-01 with total page 3280 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Generic drug entry prior to patent expiration an FTC study by :
Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Indirect Purchaser Litigation Handbook by :
Download or read book Indirect Purchaser Litigation Handbook written by and published by American Bar Association. This book was released on 2007 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Law and Economics of Generic Drug Regulation by : Christopher Scott Hemphill
Download or read book The Law and Economics of Generic Drug Regulation written by Christopher Scott Hemphill and published by Stanford University. This book was released on 2010 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: This dissertation examines the law and economics of generic drug entry, and the problems that arise from specific U.S. regulatory arrangements that govern innovation and competition in the market for patented pharmaceuticals. As Chapter 1 explains, competitive entry by generic drug makers is limited by both patents and industry-specific regulation, which together provide the means for brand-name drug makers to avoid competition and thereby recoup large investments in research, development, and testing. At the same time, the complex rules of the Hatch-Waxman Act furnish a pathway by which generic drug makers may challenge the validity or scope of brand-name patents, with a view to entering the market with a competing product prior to patent expiration. The subsequent chapters examine several aspects of the competitive interaction between brand-name and generic drug makers. Chapter 2 analyzes settlements of patent litigation between brand-name and generic drug makers, in which the brand-name firm pays the generic firm in exchange for delayed market entry. Such pay-for-delay settlements are an important, unresolved question in U.S. antitrust policy. The analysis reveals that the pay-for-delay settlement problem is more severe than has been commonly understood. Several specific features of the Act—in particular, a 180-day bounty granted to certain generic drug makers as an incentive to pursue pre-expiration entry—widen the potential for anticompetitive harm from pay-for-delay settlements, compared to the usual understanding. In addition, I show that settlements are "innovation inefficient" as a means of providing profits and hence ex ante innovation incentives to brand-name drug makers. To the extent that Congress established a preferred tradeoff between innovation and competition when it passed the Act, settlements that implement a different, less competition-protective tradeoff are particularly problematic from an antitrust standpoint. Chapter 3 synthesizes available public information about pay-for-delay settlements in order to offer a new account of the extent and evolution of settlement practice. The analysis draws upon a novel dataset of 143 such settlements. The analysis uncovers an evolution in the means by which a brand-name firm can pay a generic firm to delay entry, including a variety of complex "side deals" by which a brand-name firm can compensate a generic firm in a disguised fashion. It also reveals several novel forms of regulatory avoidance. The analysis in the chapter suggests that, as a matter of institutional choice, an expert agency is in a relatively good position to conduct the aggregate analysis needed to identify an optimal antitrust rule. Chapter 4 examines the co-evolution of increased brand-name patenting and increased generic pre-expiration challenges. It draws upon a second novel dataset of drug approvals, applications, patents, and other drug characteristics. Its first contribution is to chart the growth of patent portfolios and pre-expiration challenges. Over time, patenting has increased, measured by the number of patents per drug and the length of the nominal patent term. During the same period, challenges have increased as well, and drugs are challenged sooner, relative to brand-name approval. The analysis shows that brand-name sales, a proxy for the profitability of the drug, have a positive effect on the likelihood of generic challenge, consistent with the view that patents that later prove to be valuable receive greater ex post scrutiny. The likelihood of challenge also varies by patent type and timing of expiration. Conditional on sales and other drug characteristics, drugs with weaker patents, particularly those that expire later than a drug's basic compound patent, face a significantly higher likelihood of challenge. Though the welfare implications of Hatch-Waxman patent challenge provisions are complicated, these results suggest these challenges serve a useful purpose, in promoting scrutiny of low quality and late-expiring patents.
Book Synopsis Antitrust Analysis by : Phillip Areeda
Download or read book Antitrust Analysis written by Phillip Areeda and published by Aspen Publishing. This book was released on 2021-09-15 with total page 1175 pages. Available in PDF, EPUB and Kindle. Book excerpt: Distinguished authorship characterizes Antitrust Analysis: Problems, Text, and Cases, first written by Phil Areeda, the leading antitrust commentator of the 20th century. The text continues to be revised by three of the leading lawyer economists of the early 21st century. This traditional casebook is also known for its pedagogy (cases, explanatory text, and problems) and insightful text that conveys essential background information along with necessary economic principles. Recognizing that the most important development in antitrust doctrine over the past fifty years is the increasingly central role of economic analysis, the authors take great care to convey economic learning to students in plain language with a minimum of technical apparatus, resulting in a powerful volume adopted by experienced instructors and first-time teachers alike. Helpful appendices include Selected Statutes, such as the Sherman Act, the Clayton Act, and the Federal Trade Commission Act. New to the Eighth Edition: The addition of C. Scott Hemphill as a co-author, adding to the already distinguished author team. Since the last edition, antitrust enforcers and courts have struggled to grapple with the rising importance of platforms in our increasingly digital economy. The new edition gives extensive attention to these developments, including: The Supreme Court’s decision in Ohio v. American Express Major enforcement actions against Apple, Facebook, and Google New Vertical Merger Guidelines Completely rewritten and streamlined introductory material in Chapter 1. Professors and student will benefit from: Distinguished authorship: Original author Areeda was the leading antitrust commentator of the 20th century; Kaplow, Edlin, and Hemphill are leading lawyer-economists of the early 21st century. Pedagogy: Traditional casebook with cases, explanatory text, and problems. Insightful textual explanations convey essential background information and necessary economic principles. Adopted by experienced instructors and first-time teachers alike. Appendix includes selected statutes and the Sherman Act, the Clayton Act, and the Federal Trade Commission Act. Teaching materials Include: Teacher’s Manual
Book Synopsis Anthrax in Humans and Animals by : World Health Organization
Download or read book Anthrax in Humans and Animals written by World Health Organization and published by World Health Organization. This book was released on 2008 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fourth edition of the anthrax guidelines encompasses a systematic review of the extensive new scientific literature and relevant publications up to end 2007 including all the new information that emerged in the 3-4 years after the anthrax letter events. This updated edition provides information on the disease and its importance, its etiology and ecology, and offers guidance on the detection, diagnostic, epidemiology, disinfection and decontamination, treatment and prophylaxis procedures, as well as control and surveillance processes for anthrax in humans and animals. With two rounds of a rigorous peer-review process, it is a relevant source of information for the management of anthrax in humans and animals.
Book Synopsis Healthcare Antitrust, Settlements, and the Federal Trade Commission by : James Langenfeld
Download or read book Healthcare Antitrust, Settlements, and the Federal Trade Commission written by James Langenfeld and published by Emerald Group Publishing. This book was released on 2018-08-30 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume of Research in Law and Economics contains articles that address important legal and economic developments in the areas of healthcare, intellectual property and labor settlements, competitive effects, cartel overcharges, and the U.S. Federal Trade Commission (FTC)
Book Synopsis Antitrust Analysis by : Phillip Areeda
Download or read book Antitrust Analysis written by Phillip Areeda and published by Aspen Publishers. This book was released on 1997 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reorganized for increased accessibility, The 1997 edition of ANTITRUST ANALYSIS presents coverage of current issues with the same incisive -- and effective -- approach that has earned the book its premier reputation in the field. The distinctive emphasis on textual explanations that has always characterized Antitrust Analysis continues in the Fifth Edition. These strong textual discussions convey essential background information and necessary economic principles. Further, less significant cases have been trimmed. The authors' vast expertise in antitrust and economics is shown in a casebook of truly unrivaled quality. ANTITRUST ANALYSIS, Fifth Edition, opens with a clear introduction To The history of antitrust law and a cogent presentation of important economics material. The authors then explore: horizontal agreements monopolization vertical agreements mergers price discrimination Reflecting ongoing movement in the antitrust arena, Areeda and Kaplow now address new developments in: intellectual property health care international aspects of antitrust law
Author :Centers for Disease Control and Prevention CDC Publisher :Oxford University Press ISBN 13 :0190628634 Total Pages :705 pages Book Rating :4.1/5 (96 download)
Book Synopsis CDC Yellow Book 2018: Health Information for International Travel by : Centers for Disease Control and Prevention CDC
Download or read book CDC Yellow Book 2018: Health Information for International Travel written by Centers for Disease Control and Prevention CDC and published by Oxford University Press. This book was released on 2017-04-17 with total page 705 pages. Available in PDF, EPUB and Kindle. Book excerpt: THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel has never been greater. For both international travelers and the health professionals who care for them, the CDC Yellow Book 2018: Health Information for International Travel is the definitive guide to staying safe and healthy anywhere in the world. The fully revised and updated 2018 edition codifies the U.S. government's most current health guidelines and information for international travelers, including pretravel vaccine recommendations, destination-specific health advice, and easy-to-reference maps, tables, and charts. The 2018 Yellow Book also addresses the needs of specific types of travelers, with dedicated sections on: · Precautions for pregnant travelers, immunocompromised travelers, and travelers with disabilities · Special considerations for newly arrived adoptees, immigrants, and refugees · Practical tips for last-minute or resource-limited travelers · Advice for air crews, humanitarian workers, missionaries, and others who provide care and support overseas Authored by a team of the world's most esteemed travel medicine experts, the Yellow Book is an essential resource for travelers -- and the clinicians overseeing their care -- at home and abroad.
Book Synopsis Collective Redress and EU Competition Law by : Eda Şahin
Download or read book Collective Redress and EU Competition Law written by Eda Şahin and published by Routledge. This book was released on 2018-12-07 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: Exploring obstacles to effective compensation of victims of competition infringements, this book categorises the types of victims harmed and the types of losses arisen from these infringements to identify to what extent there is a need for enhanced private competition law enforcement in the European Union (EU) and the best way to address this need. It shows that there is a genuine need for facilitating consumer damages actions and that consumer claims are the only claims that can be pursued in a collective redress action. In order to compensate consumers and overcome barriers to effective enforcement of their right to damages, it structures a collective redress action for consumers by considering the following elements: i. the formation of the group, ii. the type of representative party iii. funding mechanisms and iv. calculation and distribution of damages.
Book Synopsis Reports of Cases Determined in the Courts of Appeal of the State of California by :
Download or read book Reports of Cases Determined in the Courts of Appeal of the State of California written by and published by . This book was released on 2011 with total page 1480 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Cambridge Handbook of Antitrust, Intellectual Property, and High Tech by : Roger D. Blair
Download or read book The Cambridge Handbook of Antitrust, Intellectual Property, and High Tech written by Roger D. Blair and published by Cambridge University Press. This book was released on 2017-04-07 with total page 873 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Cambridge Handbook, edited by Roger D. Blair and D. Daniel Sokol, brings together a group of world-renowned professors in the fields of law and economics to assess the theory and practice of antitrust, intellectual property, and high tech. With the increased globalization of antitrust, a better understanding of how law and economics shape this interface will help academics, policymakers, and practitioners to understand the existing state of academic literature, its limits, and its relevance to real-world antitrust. The book will be an essential resource for anyone seeking to understand academic and policy considerations shaping the world of antitrust, intellectual property, and high tech.
Download or read book Docket No. 9373 written by and published by . This book was released on 1947 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Quinolones by : Vincent T. Andriole
Download or read book The Quinolones written by Vincent T. Andriole and published by Elsevier. This book was released on 2000-10-09 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quinolones constitute a large class of synthetic antimicrobial agents that are highly effective in the treatment of many types of infectious diseases, particularly those caused by bacteria. New quinolones are continually being developed as bacterial species develop resistance to existing quinolones. This book presents the most current information available in our continual struggle to conquer disease. Over time, bacteria become resistant to medicines that are used to combat them. Because of this, the medical world is always in search of new and improved ways to battle these disease-causing bacteria. Quinolones are at the forefront of this research. Edited by one of the world's foremost authorities on the subject, the third edition of this highly successful title will serve as a valuable tool for primary care physicians and researchers interested in a comprehensive, up-to-date reference on the chemistry, mechanisms of action, development of resistance, and clinical efficacy of both currently available and newer quinolone compounds under investigation. This is the eagerly anticipated fully revised edition of the standard reference in the field. - Eagerly anticipated updated edition of noted title covering synthetic microbial agents that are useful against infectious disease, particularly those caused by bacteria - Edited by one of the foremost experts in the field of quinolone research and infectious disease - History of quinolones, chemistry & mechanisms of action, pharmacology, safety aspects - Role of quinolones in treating various types of infections, including respiratory infections, gastrointestinal infections, urinary tract infections, prostatitis, STDs and bacterial meningitis as well as their use in immunocompromised patients
