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| September 8, 2011 | ISSUE NUMBER 216 VOL 8 |
Economy
PBMs to Super Committee: Take $100 Billion From Pharma
A trade group representing the largest pharmacy benefits managers has proposed a way to trim $100 billion in government costs for prescription drugs over 10 years. To the pharmaceutical industry, that trim might look more like a beheading
...Read More
Educational Video:
Improving Clinical Operations with Digital Signatures
The majority of large CROs and Pharmas are using digital signatures to speed clinical site initiation, reduce site monitoring reporting costs, and improve audit efficiency.  Watch this short video to learn how digital signatures enable these benefits and others. |
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Regulatory
How Do We Regulate Synthetic Biology?
Debates over the role of government in stimulating economic growth are inviting opinions from all sides of the political spectrum, but there is generally one agreed-upon precept: Innovation is a valuable tool to create and sustain economic growth. But how does the quest for innovation square with government regulation? That debate is taking shape not only broadly but in the nascent field of synthetic biology, where scientific, public health, and business interests are converging ...Read More
Drug Safety
FDA Publishes Draft Guidance on Tablet Scoring
With insurance companies and doctors increasingly recommending that patients split tablets to adjust the dose or reduce costs, FDA has indicated that tablet splitting could raise safety concerns, especially when tablets are not scored or evaluated for splitting. Its new draft guidance lists recommendations to follow, data to provide, and criteria to meet ...Read more
Emering Pharma Leaders
Leadership in a Lean Market
Can ‘lean’ management, as opposed to products, be a driver of innovation, particularly on the neglected side of business processes? Pharm Exec’s 2011 Emerging Pharma Leaders give their views in these exclusive podcasts ...Listen now
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 // Steve Engle resigned from his positions as Chief Executive Officer, President, and Chairman of the Board of XOMA (Berkeley, Calif.). The Board appointed John Varian as interim Chief Executive Officer and W. Denman Van Ness, XOMA's Lead Independent Director, as Chairman. // Linda Deal joined ERT (Philadelphia) to lead the company's Health Outcomes Research Initiatives. // MediciNova (San Diego) appointed Kazuko Matsuda, MD, PhD, MPH, as Chief Medical Officer and Michael Gennaro CPA, MBA, as Chief Financial Officer. //
Quintiles appointed Oren Cohen Senior Vice President and Global Head of its Phase I Clinical Research division. |
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