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This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

Commercial pharmaceutical companies have been much criticised for their activities yet, at the same time, there is relatively little ethical information available to those working in the industry. This book addresses this need and develops pharmaceutical ethics as a field independent to medical ethics in general

Intro -- PHARMACEUTICAL INNOVATIONCHALLENGES AND COMPETITORS -- PHARMACEUTICAL INNOVATIONCHALLENGES AND COMPETITORS -- CONTENTS -- Preface -- Chapter 1 - Drug Patent Expirations:Potential Effects on Pharmaceutical Innovation( -- Summary -- Introduction -- The Pharmaceutical Industry -- Role of Patents -- The Hatch-Waxman Act -- Patent Expirations -- Innovation Issues -- Blockbuster Drugs and the Innovation Pipeline -- Drug Approvals -- Productivity Issues -- Concluding Observations -- End Notes -- Chapter 2 - Authorized Generic Pharmaceuticals: Effects on Innovation -- Summary -- Marketing Approval and Patent Issues for Generic Drugs -- FDA Approval Procedures -- Resolution of Patent Disputes -- Generic Marketing Exclusivity -- The Concept of Authorized Generics -- Authorized Generics Practice -- Authorized Generics within the Hatch-Waxman Framework -- Legality of Authorized Generics -- Concluding Observations -- End Notes -- Chapter 3 - Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation -- Summary -- Patent Disputes under the Hatch-Waxman Act -- Patent Fundamentals -- FDA Approval Procedures -- Resolution of Patent Disputes -- Generic Exclusivity -- Fundamentals of Reverse Payment Settlements -- Antitrust Implications of Reverse -- Payment Settlements -- Sixth Circuit -- Eleventh Circuit -- Second Circuit -- Federal Circuit -- Issues and Observations -- End Notes -- Chapter 4 - The Hatch-Waxman Act: A Quarter Century Later -- Summary -- Introduction -- Overview of the Original Act -- Accelerated Generic Drug Approval Process -- Patent Term Restoration -- Data Exclusivity -- Amendments: The Medicare Prescription Drug and Modernization Act of 2003 -- Implementation -- Selected Issues -- Authorized Generics59 -- Patent Settlements76 -- Follow-On Biologics82 -- Concluding Observations -- End Notes

Cover -- Table of Contents -- Amgen Inc -- Astellas Pharma Inc -- AstraZeneca -- Bayer HealthCare -- Bristol-Myers Squibb -- Eli Lilly and Company -- GlaxoSmithKline -- Johnson & -- Johnson -- LEO Pharma -- Merck KGaA -- Novartis AG -- Novo Nordisk -- Pfizer -- Pharmasset Inc -- Rosetta Inpharmatics Inc -- Sanofi-Aventis -- Wyeth -- XenoPort Inc -- Additional Research -- Index.

Today, pharmaceutical companies are increasing theirmarketing budgets to advertise directly to the consumer.This spiraling effort has begun to attract the attention of bothconsumer advocacy groups, as well as the federal government(in the USA), in terms of taking a closer look at the effects ofsuch advertising efforts. In July of 2005, the US SenateMajority leader asked pharmaceutical marketers to voluntarilystop their direct-to-consumer advertising during a drug's firsttwo years on the market. The ability for a pharmaceuticalcompany to affect both the physician (who can prescribe aspecific dr