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 October 29, 2015 | ISSUE NUMBER 424 VOL 4
Pricing
Drug Pricing Backlash Reaches Fever Pitch
Activities by Turing and Valeant Pharmaceuticals have focused negative attention on hefty price hikes for old medicines. Even generic drug makers are now under scrutiny following steep increases for traditionally cheap, widely used parenterals. Jill Wechsler reports
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Pricing
Barrier to Generic Competition Threatens Safe, Low Cost Drug Options
FDA calls brand companies denying generic competitors access to Reference Listed Drug samples needed for bioequivalence testing a “growing major problem”. Carlos Angulo and Alexandra W. “Sasha” Miller argue that such company tactics are threatening to undermine the entire generic drug approval process
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Regulatory
FDA Looks to Limit Clinical Trials in Biosimilar R&D
With one approved biosimilar under its belt, and dozens more under review and in development, FDA’s biosimilar development program is moving “beyond the finish line”. But agency officials still have much to do to address critical issues related to product analysis and testing
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Comment
Hillary's History on Rx Price Controls
We may think we know all about Senator Clinton's view on drug and price controls, but to figure out when and how she arrived at her current position, Tom Norton looks at how her stance has evolved over the last 22 years
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Sample Management Spotlight: Your ability to efficiently put samples in the hands of your sales force, your prescribers and, ultimately, patients impacts your sales, marketing and compliance operations. Learn what today’s industry leaders are doing to ensure that their sample management activities are both effective and compliant, while minimizing administrative burden on your internal staff.
To learn more click here.
Global
Market Access in China
Manufacturers have struggled to realise China's true potential due to its complexity and fragmentation. Recently, the government has focused on improving the quality of healthcare, relaxing certain regulatory policies, and allowing market forces to drive healthcare and pricing reform. Michael J. Kuchenreuther looks at these initiatives and assesses their potential impact on global pharmaceutical manufacturers
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Pharmaceutical Executive E-Book – Coming November 2015: Securing the Global Supply Chain: Strategies for Operational Excellence
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- Compliance Groundswell: What are the New Rules and Regulator Expectations?
- Global Dynamics of Risk: Can Technology Keep Pace?
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Contact your sales rep for more information and to secure your sponsorship.
//CoLucid Pharmaceuticals (Cambridge, MA) announced that Mark Corrigan M.D. has been elected by the Board of Directors to serve as a director.//Amarantus Bioscience Holdings (San Francisco, CA) appointed Curtis Scribner, M.D., MBA as Senior Vice President of Regulatory Affairs.//Cesca Therapeutics (Rancho Cordova) appointed Michael Bruch Chief Financial Officer.//G1 Therapeutics (Research Triangle Park, NC) appointed Glenn P. Muir, CPA, to its Board of Directors.//RedHill Biopharma (Tel-Aviv, Israel) announced that Ori Shilo, a co-founder of RedHill, has informed the company of his intention to resign from his position as Deputy Chief Executive Officer, Finance and Operations and as a director in order to pursue other opportunities.//
U.S. Market Access
Key Learnings from a recent success story

Live Webinar: Thursday, November 19th, 2015 at 11 AM EST
Join Randolph Carpio from Quintiles, and Joe Bonaccorso from Pierre Fabre as they discuss the importance of getting the reimbursement, access and distribution strategy correct to make the most of the opportunities in the U.S.
Register for free Webinar
November 16–17: Life Science Competition Congress
Morristown, NJ.


November 18–19: Global Compliance Congress
Munich, Germany.


January 28–29, 2016: 11th Summit on Biosimilars
Alexandria, VA.
How intelligent is your multichannel strategy?
Live webinar: Wed., Nov. 4, 2015 at 11:00 AM EST
Join Drew Romes and Kyu Om from Quintiles, as the key steps to enable a successful implementation of truly integrated multichannel engagement programs as part of your marketing activities.
Register for free
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