Monthly Archives: February 2012

2012: A Good, Bad, and Ugly Year for France's Servier

By Nathan Jessop. Whichever way you look at it, 2012 will be a dramatic year for Servier. The French company has a number of collaborations that could lead to a new generation of products, but any positive news from these developments is likely to be overshadowed by the ongoing safety scandal of its diabetes treatment […]
Posted in Europe, Global, Guest Blog, Regulatory, Safety | Tagged , , | Leave a comment

FDA: Steps Toward Quantitative Safety Assessment

A new collaboration will move FDA closer to predicting adverse events – before they happen – as part of the regulatory process In an article published in Nature last June, FDA’s Darrell Abernethy, Lawrence Lesko and Janet Woodcock outlined the agency’s desire to incorporate “mechanism-based drug safety assessment and prediction” into the regulatory approval process. […]
Posted in FDA, R&D, Regulatory, Safety, Technology | 1 Comment

A Dialogue on Patient Access Programs

As health reforms sweep in major changes to our nation’s healthcare system, patient assistance and access programs  (PAPs) are rapidly evolving to assess and meet new needs. As millions of uninsured Americans gain some form of insurance coverage, manufacturer-sponsored PAPs face unprecedented challenges as they rise up to evolve the PAP model to best address […]
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Compliance: Europe Feels the Sunshine

As the perceived urgency for transparency and compliance in global pharma grows ever stronger, the ‘Sunshine provisions’ of the US’s Patient Protection and Affordable Care Act (ACA) seem increasingly aptly named. The spotlight that has been exposing and illuminating – and sometimes burning – issues around the financial interests of physicians and academic medical centers […]
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Can Sanofi's Expanding Predictive Modeling Technology Enhance the Productivity of R&D?

As the hurdles to successful commercialization of new medicines continue to mount, the ability to find and exploit cost efficiencies in the development process has become a critical source of competitive advantage.  This is true not only for biologic drugs but also increasingly for vaccines, now a high growth segment of the medicines business, with […]
Posted in Biotech | Tagged , , , | Leave a comment
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