Tag Archives: Regulatory

The Curious Case Of AstraZeneca v. ACE

by Mike Kelly and Andrew Dupre Insurance contracts are a language game that must be played very carefully, as AstraZeneca learned. From 2003 to 2012, AstraZeneca Plc was locked in one of the largest mass tort litigations in the United States, defending its blockbuster second generation atypical antipsychotic product Seroquel from allegations of failure-to-warn of […]
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Orphan Drug Laws: A Pharmacist's Perspective

Orphan Drug Laws:  A Pharmacists’ Perspective Guest blogger Dr. Albert Wertheimer Professor and Director, Health Services Research Temple University Philadelphia PA Pharm Exec’s sister organization CBI hosted its annual Orphan Drug Innovation Summit in Philadelphia on July 17-18.  This is a topic that I have professional interest in, as well as a general curiosity.  I […]
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Breaching the Great Wall: Major Pharma Changes Proposed in China

With a revision of China’s basic drug approval law now underway, a multinational team of experts is proposing major changes to make the country a world class player in innovation. Dr. Wang Chenguang, Dean of Tsinghua Law School Behind the vaulting growth statistics that make China the centerfold in Big Pharma’s global playbook is a […]
Posted in compliance, Emerging Markets, Global, IP, R&D, Regulatory | Also tagged , , , , , , , , , | 3 Comments

Why Patient Adherence is a Policy Issue

Joe Ganley, Director of State Government Affairs at McKesson, spoke earlier this year on public health policy and its implications for patient adherence. Here, he provides PharmExec with some highlights of that presentation. PEGD: Why is adherence getting so much attention lately? Medication adherence has always been important to maintaining patient health; however, the enormous […]
Posted in Guest Blog, healthcare, patient compliance, Regulatory | Also tagged , , , , , | 1 Comment

Drug Patents Under Fire in Brazil

by Ryan O’Quinn & Sanya Sukduang One of the most promising pharmaceutical markets of the future is Brazil, a nation of nearly 200 million people with a universal healthcare system.  Brazil’s infamously overloaded patent system has undergone a series of recent reforms.  One such “reform,” however, greatly complicates biopharmaceutical patent practice: any Brazilian patent application […]
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