PharmExec Blog

BIO 2014 Takeaway: The Peace Dividend

William Looney

William Looney

A surprising take away from the BIO International Convention in San Diego last month is the stark contrast between cooperative industry engagement and an unstable geopolitical order marked by xenophobia, drift and active, often violent government disengagement from the hard work of building common ground.

While BIO held 29,000 partnering meetings over four days, convened the first meeting of a new 20-member International Council of Biotech Associations (ICBA), and launched an industry-wide commitment to fighting anti-microbial resistance, Convention keynoter Hillary Clinton spent all but six minutes of her 90-minute issues tour d’ horizon covering the sad breakdown of good governance and peaceful dialogue in virtually every area of public life. Read More »

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Takeda's New Vaccines Division Charts Course to Global Growth

Today’s vaccines business represents an almost perfect world for big Pharma. There is a vast landscape of unmet medical need; lots of new science; longer product life cycles, with low exposure to post-patent generic competition; greater stability in pricing and supply commitments; more cost-effective manufacturing and delivery technologies; and the reputational gains that come from fulfilling a highly visible public health mission.

While the established players strive to keep their lead, and others contemplate entering the space for the first time, one company—Takeda Pharmaceuticals—is moving to up its game, with a commitment to build a truly global vaccines business founded on its historical roots in Japan, where it began producing vaccines for generations of children and adults in 1946, just months after the end of World War II. Read More »

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Experts Tell Congress How to Streamline Clinical Trials

Key to accelerating the discovery and development of new medical therapies is to improve the clinical research process, according to leaders of biopharmaceutical research community. As part of its 21st Century Cures Initiative, the House Energy & Commerce Committee called on representatives of industry and academia to present strategies for reducing regulatory oversight, speeding up clinical research processes, and utilizing technology to better understand the potential benefits and risks of promising new treatments.

Roy Herbst, chief of medical oncology at the Yale Cancer Center, described how a public-private partnership is organizing an innovative multi-center lung cancer study. The program features a master protocol for all sites, which promises to streamline patient enrollment, gain operational and cost efficiencies, and produce more consistent and transparent results. Read More »

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EMA Delays Adoption of Policy on Publishing Trial Data

The European Medicines Agency (EMA) has postponed formal adoption of the policy on publication of clinical trial data. An EMA press statement said that “[f]urther clarifications on wording and practical arrangements will be discussed by Board members”, whose additional contributions will now be considered with a view to reaching final agreement at the Management Board meeting on 2 October.

EMA referred to “the complexity of the debate on both political and technical aspects, which have emerged during the previous general and more targeted consultation phases”, adding that, in the last 12 months, it has “attempted to strike a balance between proactive data disclosure, the absolute need to protect personal data and the concerns relating to the protection of commercially confidential information.”

 

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Further Boost for Europe’s Largest Healthcare Partnership

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has announced the launch of IMI2, with a budget of €3.3 billion (US$ 4.5 bn).

IMI (the Innovative Medicines Initiative) is a public-private partnership (PPP) between the European Commission and EFPIA, and was already the largest healthcare PPP in Europe. The budget for its first phase (2008-2013) was €2 bn (US$2.7 bn).  Read More »

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