Guide to Biosimilars Litigation and Regulation in the U.S.

Guide to Biosimilars Litigation and Regulation in the U.S. PDF Author:
Publisher:
ISBN: 9781731923752
Category : Drugs
Languages : en
Pages : 0

Get Book Here

Book Description

Guide to Biosimilars Litigation and Regulation in the U.S.

Guide to Biosimilars Litigation and Regulation in the U.S. PDF Author:
Publisher:
ISBN: 9781731923752
Category : Drugs
Languages : en
Pages : 0

Get Book Here

Book Description


Guide to Biosimilars Litigation and Regulation in the U.S.

Guide to Biosimilars Litigation and Regulation in the U.S. PDF Author:
Publisher:
ISBN: 9781731952295
Category : Drugs
Languages : en
Pages : 0

Get Book Here

Book Description


Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade PDF Author: World Intellectual Property Organization
Publisher: WIPO
ISBN: 9280523082
Category : Law
Languages : en
Pages : 259

Get Book Here

Book Description
This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

Making Medicines Affordable

Making Medicines Affordable PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309468086
Category : Medical
Languages : en
Pages : 235

Get Book Here

Book Description
Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

Pharmaceutical Lifecycle Management

Pharmaceutical Lifecycle Management PDF Author: Tony Ellery
Publisher: John Wiley & Sons
ISBN: 0470487534
Category : Medical
Languages : en
Pages : 412

Get Book Here

Book Description
A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand explores this increasingly important field to help readers understand what they can—and must—do to get the most out of their brands. Offering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future. While the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. Pharmaceutical Lifecycle Management walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation.

Tackling Wasteful Spending on Health

Tackling Wasteful Spending on Health PDF Author: OECD
Publisher: OECD Publishing
ISBN: 9264266410
Category :
Languages : en
Pages : 306

Get Book Here

Book Description
Countries could potentially spend significantly less on health care with no impact on health system performance, or on health outcomes. This report reviews strategies put in place by countries to limit ineffective spending and waste.

WHO guideline on country pharmaceutical pricing policies

WHO guideline on country pharmaceutical pricing policies PDF Author:
Publisher: World Health Organization
ISBN: 9240011870
Category : Business & Economics
Languages : en
Pages : 70

Get Book Here

Book Description
In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.

FDA Approved Animal Drug Products

FDA Approved Animal Drug Products PDF Author:
Publisher:
ISBN:
Category : Veterinary drugs
Languages : en
Pages : 144

Get Book Here

Book Description


Pharmaceuticals, Corporate Crime and Public Health

Pharmaceuticals, Corporate Crime and Public Health PDF Author: Graham Dukes
Publisher: Edward Elgar Publishing
ISBN: 1783471107
Category : Business & Economics
Languages : en
Pages : 419

Get Book Here

Book Description
The pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the pr

Private Patents and Public Health

Private Patents and Public Health PDF Author: Ellen F. M. 't Hoen
Publisher:
ISBN: 9789079700851
Category :
Languages : en
Pages : 181

Get Book Here

Book Description
Millions of people around the world do not have access to the medicines they need to treat disease or alleviate suffering. Strict patent regimes introduced following the establishment of the World Trade Organization in 1995 interfere with widespread access to medicines by creating monopolies that keep medicines prices well out of reach for many. 0The AIDS crisis in the late nineties brought access to medicines challenges to the public?s attention, when millions of people in developing countries died from an illness for which medicines existed, but were not available or affordable. Faced with an unprecedented health crisis ? 8,000 people dying daily ? the public health community launched an unprecedented global effort that eventually resulted in the large-scale availability of low-priced generic HIV medicines. 0But now, high prices of new medicines - for example, for cancer, tuberculosis and hepatitis C - are limiting access to treatment in low-, middle and high-income countries alike. Patent-based monopolies affect almost all medicines developed since 1995 in most countries, and global health policy is now at a critical juncture if the world is to avoid new access to medicines crises. 0This book discusses lessons learned from the HIV/AIDS crisis, and asks whether actions taken to extend access and save lives are exclusive to HIV or can be applied more broadly to new global access challenges.