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Agency's plan for reporting clinical trial data has sparked strong reactions from health campaigners, industry, and patients.

In this special issue of Pharm Exec Global Digest: Unlocking the true value of Big Data; Data privacy and the health sciences; In-silico modeling and real-word outcomes; and more...

Pharm Exec talks with Dr. Sergio Pecorelli, Chairman of the Italian Medicines Agency (AIFA), an organization respected in global regulatory circles for its precedent-setting work on advanced cost-effectiveness metrics.

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Although progress has been made in bringing biosimilars to market, gaps in requirements for testing and documenting product similarity are still hampering the EU, U.S., and other regions, writes Jill Wechsler.

The EU may have a new monitoring scheme for Iceland's volatile geology, but it should also heed the volcano that could blow apart its assumptions on drug pricing and reimbursement, says Reflector.

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Country Report: Spain

Spain's recession-battered pharma sector adapts to a changing market environment and repositions itself for a return to healthy growth through expanding opportunities abroad.

Leaders from industry, government, and the CRO community examine Ireland's future as a magnet for life science investments, and what the nation must do to remain the leading exporter of finished pharmaceutical products.

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Country Report: Chile

2014 kicks off a defining period for healthcare in Chile as a new national drug law is implemented, with the hopes of creating a system that makes access to medicines easier and more transparent for patients.

This year's class of 15 young executives is deeply of the moment, with wide-ranging therapeutic, business, and operational expertise-all binded by an underlying commitment to the patient.

French Connections

The Galien Foundation and the French government investment agency UBIFRANCE have partnered to establish UBISTART, a transatlantic payout for the best in start-up innovations. William Looney reports.

As the "Sovaldi Saga" unfolds in the U.S., it's clear the situation will only deteriorate. But north of the border, it's striking how Canadian healthcare entities are managing a similar Sovaldi situation, writes Tom Norton.

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Poland's pharma industry, the largest in Central and Eastern Europe, confronts the fallout from the government's controversial 2012 Reimbursement Act.

India must still be included in the list of promising potential markets for global pharma manufacturers, writes Jill E. Sackman and Michael Kuchenreuther.

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Rare allies-innovator and generic pharmas-are calling for policy integration in Europe. But ideology and newfound scepticism on the merits of drugs in healthcare could complicate the effort.