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September 25, 2014 | ISSUE NUMBER 370 VOL 4

Deals
Pharma M&A: Diverse and Accelerating
There have never been as many different strategies followed by pharma companies as there are today. Time will tell which are the most compelling and successful; for now, Pharm Exec Editorial Advisor Peter Young provides some examples of how companies have been shifting their strategies ...Read more

R&D
Gaps in Global Standards Threaten Biosimilar Developoment
Although biopharmaceutical companies and regulatory authorities have made considerable progress in establishing policies for bringing biosimilars to market, disagreement over data requirements, testing approaches and legal frameworks threaten to discourage broader biosimilar development, writes Jill Wechsler ...Read more

Inspection Focus in Clinical Trials Using a Risk-Based Monitoring Approach
How will clinical trials that adopt an RBM approach be inspected? Covance shares actionable insights to start answering this vitally important question. Learn more

Emerging Markets
Investing in African Healthcare: Study, Share, Act — and Grow
Is sub-Saharan Africa a jewel box of untapped assets for a growth-obsessed big Pharma? Some of the majors apparently think so. To identify some benchmarks for best practices in building a viable drugs business in Africa, we spoke to Steven Adjei, native Ghanaian and founding partner of a start-up business “incubator” firm focused on opportunities in the sub-Saharan region ...Read more

Improve Compliance with Aggregate Spend and Transparency Analytics
While most aggregate spend solutions provide the necessary legal view of data, AggregateSpend360’s Transparency Insights dashboard provides a more analytic view of data, allowing pharmaceutical and medical device companies to take aggregate spend and transparency data beyond compliance reporting.  Learn how advanced analytics and a 360° view of customer payments can improve your compliance and business activities.

Europe
What Does the Future Hold for European Health Policy?
The upcoming face-off between the European Parliament and the political figures that the member states have designated as European commissioners is now an established practice, but is not guaranteed to shed much light on the future of health policy. It does, however, say a little about the preoccupations and predilections of the parliament, writes Peter O’Donnell ...Read more

E-Book: Celebrating 50 Years of DIA
This commemorative e-book includes special articles, as well as DIA session highlights and news that pharmaceutical and clinical trial professionals will find important and informative.Download Today

Regulatory
FDA Readies Quality Metrics Measures
After almost two years of discussion and analysis, FDA is finalizing a proposal for collecting data from manufacturers to help measure the performance of manufacturing operations and the quality of resulting drugs and biologics ...Read more

Establishing Processes and Controls to Ensure an
Inspection-ready TMF Every Day
Wednesday, October 01, 2014, 02:00 PM Eastern Daylight Time
Register Free at: www.pharmexec.com/inspection

//ChemoCentryx (Mountain View, CA) appointed Israel F. Charo, M.D., Ph.D., as Senior Vice President of Research.//Avalanche Biotechnologies (Menloe Park, CA) announced the appointment of Roman G. Rubio, M.D., as Senior Vice President and Head of Translational Medicine.//NOXXON Pharma appointed Don Munoz to the newly created position of Chief Financial Officer, based in the company’s new subsidiary office in Boston, MA.//AmpliPhi BioSciences Corporation (Richmond, VA) announced that its President and CEO, Philip J. Young, has stepped down. Chairman, Jeremy Curnock Cook will serve as Interim CEO and Wendy Johnson, a member of AmpliPhi’s Board or Directors, will serve as Interim COO.//

October 21–22: International Pharmaceutical Compliance Congress
Brussels, Belgium.


November 5–6: Real World Data/Late Phase Summit
Philadelphia, Pennsylvania


Jan 29–30, 2015: 10th Annual Summit on Biosimilars
Washington, DC



 
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