PharmExec Blog

GSK and Novo Nordisk Lead on Access Index

On Monday, the Access to Medicine Foundation released its 2014 Index rating the performance of companies in broadening access to medicines in low and middle-income countries.

For the fourth time, GSK leads the index with Novo Nordisk taking second. J&J. Novartis, Gilead and Merck KGaA rank three to six with nearly even scores.

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CytRx Faces Partial Clinical Hold after Death in Compassionate Use Program

CytRx announced on Tuesday that FDA gave notice of a partial clinical hold for trials for its oncology candidate aldoxorubicin.

The hold results from a reported death of a late-stage cancer patient “who did not qualify to participate in any of the ongoing aldoxorubicin clinical trials, but had received aldoxorubicin under the Company’s expanded access (“compassionate use”) program”, states the release. Read More »

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FDA "Stymies Competition in Drug Industry", Says PCMA

By Randi Hernandez.

The Pharmaceutical Care Management Association (PCMA), an organization that represents the nation’s leading pharmacy benefit managers (PBMs), which administer prescription drug plans for over 210 million Americans, released a new white paper investigating FDA’s influence on drug prices and competition in the pharmaceutical marketplace. The PCMA argues that competition within branded drugs is undervalued in FDA priorities and that FDA’s structures and regulations fundamentally hinder competition.

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EMA Revises Conflict-of-Interest Policy

The European Medicines Agency (EMA) has published its revised policy on handling declarations of interests for scientific-committee members and experts.

The revisions strive for a more balanced approach in restricting the involvement of experts with possible conflicts of interests in the Agency’s work, while maintaining access to expertise. Read More »

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How Gilead “Blew Out the Lights” With Sovaldi

While flipping through my emails last week, I froze before an image that appeared on my screen. An old Rx colleague had sent me a graph, mapping out the 2014 U.S. sales achieved by Gilead’s Hep C drug, Sovaldi. It was stunning. Take a look: Read More »

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