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June 26, 2014 | ISSUE NUMBER 357 VOL 4

Social Media
FDA Talks Social Media
Instead of repeating his yearly Drug Information Association (DIA) Annual Meeting claim that social media guidance remains among the FDA’s Office of Prescription Drug Promotion’s “highest priorities” to be published in due course, Tom Abrams, director of OPDP, had real news to discuss this time around. Pharm Exec’s Ben Comer was there this week to hear it ...Read more

Inspection Focus in Clinical Trials Using a Risk-Based Monitoring Approach
Current regulatory guidance from FDA and EMA explains how risk-based monitoring (RBM) should be implemented within a quality management system. However, a key question is left unanswered: How will clinical trials that adopt an RBM approach be inspected? In this hot-off-the-press whitepaper, Covance shares actionable insights and a summary of the indications our RBM experts have received, to start answering this vitally important question.Read more

Social Media
The Social Media Questions Pharma Companies Should be Asking
For pharma companies, entering the social media scene is not as simple as just creating a Facebook page or learning how to tweet in 140 characters or less. Social media poses a regulatory and litigation maze that must be carefully navigated. Here, Mathew dos Santos and Lori Leskin provide some insight into the most pressing questions companies are, or should be, asking about social media ...Read more

The lifecycle of a new product is shorter, more contested, full of regulatory delays, and beset by a challenging access and reimbursement environment.  Learn how to wrest maximum value from every stage of the lifecycle – from access to acquisition to adherence – by downloading this eBook.Read more

R&D
Comparative Effectiveness Research: New and Emerging Trends
While at DIA’s 50th Annual Meeting, Pharm Exec got the chance to speak with Nancy Dreyer — chief of scientific affairs and senior VP at Quintiles Outcome and leader of the GRACE Initiative — about how comparative effectiveness research (CER) has evolved and where it is leading ...Read more

Global
Desperate Measures: Industry Teams with Parallel Traders to Tackle Counterfeiters in Europe
An improbable cross-sector partnership is struggling to secure support for a pan-European system to keep counterfeits out. It’s improbable because it brings together not only manufacturers, wholesalers, and pharmacists, but also parallel traders — long treated by drug manufacturers as pariahs and even downright enemies
...Read more

Biosimilars: Friend or Foe to Healthcare?
July 16, 2014 at 11:00 AM EDT
To Register free: www.pharmexec.com/biosimilars

Pharma 50
The Top 50 Pharma Companies
The vigorous return of M&A activity to biopharmaceuticals this year begs the question: is more size and scalable efficiencies the best solution to the declining market power of pharmaceuticals in an endlessly restructuring healthcare system? Our latest annual iteration of the Pharma 50 rankings confirms that the answer to this is ‘no’
...Read more

New Report
Product Cycle Strategies for Greater Profitability
In this compilation of four in-depth, data-rich reports from Pharmaceutical Executive, you'll learn a new set of metrics allowing companies to align their strategies around the push for greater profitability, putting them on the right track
...Click here to order

//Anthera Pharmacueticals, Inc. (Hayward, CA) appointed Brian R. Muller to its Board of Directors.//Astellas Pharma US (Northbrook, IL) named Karl Uhlendorf as Communications and Advocacy Director.//Lion Biotechnologies, Inc. (Los Angeles, CA) recruited Dr Laszlo Radvanyi as Chief Scientific Officer.//ARIAD Pharmaceuticals, Inc. (Cambridge, MA) announced three new appointments to its global management team: Timothy Maines (Vice President, Quality), Yan Moore, M.D. (Vice President, Medical Affairs), and Piet A. M. Vervaet, M.D. (Vice President, Drug Safety and Pharmacovigilance).//

August 12–13: Reimbursement and Access
Philadelphia, PA.


August 18–20: Transparency and Aggregate Spend
Washington, DC.

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



 
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