Monthly Archives: July 2013

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 […]
Posted in compliance, Europe, Guest Blog, leadership, Legal, Marketing, Regulatory, Safety, Sales, Strategy | Tagged , , , , , , , , | Leave a comment

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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Orphan Drug Adoption: the More Regulation, the Better

New survey research indicates that a country with a strong regulatory commitment for advancing drugs for rare diseases does better in getting orphan drugs to patients than countries with lesser regulatory frameworks. In his study, ‘The Effect of Market-Based Economic Factors on the Adoption of Orphan Drugs Across Multiple Countries,’ John Matthews, Associate Director of […]
Posted in Europe, Global, Market Access, Orphan Drugs, pricing, Regulatory | Tagged , , , , , , | Leave a comment

Court Ruling Threatens Drug Shortage Remedy

The Food and  Drug Administration may no longer be able to alleviate shortages in vital drugs by permitting the import of unapproved medicines following a decision by the Court of Appeals for the District of Columbia. The ruling of July 23, 2013 also raises broader questions about when and how FDA can “exercise regulatory discretion” […]
Posted in Anti-counterfeiting, FDA, Safety, Supply Chain | Tagged , , , , , , | 1 Comment

UK: NICE's Looming Value-Based Pricing Challenges

NICE role in VBP The National Institute for Health and Care Excellence (NICE) will have a vital role in the post 2014 value based pricing (VBP) world.  The Department of Health (DH) who still act as the sponsor organization for the agency, has set out in more detail just what value assessment by NICE will […]
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