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January 10, 2013 | ISSUE NUMBER 283 VOL 8

Regulatory
The Orphan Drug Act at 30: What's Next?
30 years ago last week, the US Orphan Drug Act came into being. We look at what it has achieved for rare disease treatments and what, with the recent passing of the FDA Safety and Innovation Act, the future holds ...Read more

Approvals
2012 US Drug Approvals Best in Years. But Will the Good Times Last?
Coming out of the blizzard of patent expirations, 2012's total drug approvals climbed to 39, the greatest number from the FDA since 1996. The evidence is now clear that pipeline preparations laid not just within the year but within the past decade are finally yielding results. But what will sequestration bring? ...Read More

Event
JP Morgan: Suits Take San Francisco
The perennial fat got chewed during the first two days of at J.P. Morgan's annual healthcare conference — buy back stock or raise dividends — and the usual suspects lurked. But the conference newcomers like Walgreens and the not-so-pharma-like companies such as Life Technologies packed the presentation halls and corridors, demonstrating investor and general interest in new ideas, products, and services, or "whatever makes money", in the words of one fund manager
...Read more

Video
Is Pharma Rightsized?
After years of large scale layoffs, pharma saw fewer pink slips in 2012. Are the reductions and restructuring finally over?
...View the video

Outsourcing
Guide to Strategic Outsourcing Inside Outsourcing, our new eBook
Guide to Strategic Outsourcing Inside Outsourcing, our new eBook featuring the latest articles, analyses and opinion on optimizing CRO/CMO relationships, is available for free download now
...Read more

// Steve Glaza joined SNBL USA (Everett, USA) as Director of Safety Assessment. // Specialty biotech company Discovery Labs (Warrington, PA) appointed John Cooper as its new CEO following the resignation of former chair and CEO W. Thomas Amick. // Curtis Oltmans was promoted to Corporate VP and General Counsel, legal and quality affairs at the North American division of Novo Nordisk. // Fred Powell joined Celator Pharmaceuticals (Princeton, NJ) as Chief Financial Officer.

January 24–25, 2013: 3rd Developing CAPAs in the GCP Environment Conference
Arlington, VA.


January 24–25, 2013: 5th Risk Evaluation and Mitigation Strategies Summit
Arlington, VA.


February 11–12, 2013: iPharma 2013
Philadelphia, PA.


April 29–30: 12th Annual Patient Adherence and Support Summit
Philadelphia, PA.


 
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