| September 5, 2013 | ISSUE NUMBER 315 VOL 11 |
Regulatory
Biopharma Innovation in Trouble?
Next year it will cost $2.2 million to submit an NDA or biologics license application (BLA) for FDA review, and $1 million for a supplement with clinical data, generally to support new indications or expanded labeling. Review of a new biosimilar application that carries clinical data will be just as costly. The slight drop in anticipated NDAs that is expected to result in 2014 may reflect an ever-longer and more costly drug-development process that is squeezing pharma investment in R&D ...Read more
Smart Sourcing Strategy: A Whitepaper on Pharmacovigilance Vendor Selection
Strategic planning, sourcing and implementation of pharmacovigilance operations are multi-dimensional activities. There has been a considerable increase in the quality and quantity of safety processes being outsourced due to evolution of mature processes; risk mitigation strategies and increase in vendor experiences that has helped the sponsor balance core in-house strength and leverage the service provider’s capabilities. Learn how to adopt a Smart Sourcing Strategy
 www.sciformix.com/smartsourcingstrategy
Market Access
Read the New Pharm Exec Global Digest — Market Access Special
In the new issue: Develop a Market Access Roadmap; Embed Market Access in Your Organizational Culture; Initiating Early Access Programs in Europe; and More!
...Read more
Marketing
Making Social Media Sell
Pharma companies have been widely embracing social media to advertise products, recruit staff, and report on CSP projects. But it is it doing any good? Patrick Homer reports ...Read more
Gross-to-Net Illusion or Reality: Closing the Gap between Excel and ERP
Live Webcast: Tuesday, September 17, 2013 at 1:00 EDT
Register Free at  www.pharmexec.com/grosstonet
Global
New Rules for a New Africa
Africa has long been seen as a caricature of calamity—an object lesson on what not to do in making public health a driver of balanced economic and social development. But things change. Africa now deserves a second look, however, especially as growth prospects in the mature markets of Europe and the US are fading. Indeed, Africa now presents a refreshing contrast to this politics of decline, writes Joseph Saba ...Read more
New eBook
The Best of the Successful Product Manager's Handbook Volume IV
In the fourth volume of this four-volume set from the pages of Pharmaceutical Executive, you'll arm yourself with information and expert accounts to fortify your marketing plans against both the unexpected and the inevitable ...Read more
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 //Novo Nordisk appointed Jesper Høiland as President of its US affiliate, replacing Jerzy Gruhn, who has taken over the leadership of the European business from the recently retired Martin Soeters.//MedEvoke (High Bridge, NJ) a divison of Medisys Health Communications, LLC, hired Peter Mollegard as Senior Director of Client Service.//VIVUS, Inc. (Mountain View, CA) announced that Anthony P. Zook has resigned as CEO and from the Board of Directors, due to ill health. The Board appointed Seth H. Z. Fischer, a former Senior Executive at Johnson & Johnson, to replace Mr. Zook.//Lilly added Dr Marschall Runge, Executive Dean for the School of Medicine at the University of North Carolina (UNC), to its Board of Directors.//The European Generics Association (EGA; Brussels, Belgium) appointed Adrian van den Hoven as its new Director General.// |
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Are stricter regulatory procedures restricting pharma industry growth?
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