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June 19, 2014 | ISSUE NUMBER 356 VOL 4

Deals
The Urge to Merge: Dealmaking Lessons from Pharma History
The major pressures hindering pharmaceutical industry success have not changed — payer constraints on drug costs, R&D productivity, an increasingly risk-averse regulatory climate, generic encroachment, and negative public perceptions linked to reputation. A look at Pharm Exec’s latest Pharma 50 confirms this, writes Cliff Kalb ...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

Pharma 50
Pharm 50 Trends: Past, Present, and Future
Pharm Exec's Top 50 has been around enough to reveal the importance of leading with a unique business model and then sticking with it, for the long-term. With Genentech and Teva rising triumphantly from the lower end of those early lists, what we are seeing now is a decisive distinction favoring companies that made an early commitment to focus on specialty biologics for hard-to-treat conditions affecting small target populations ...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

Specialty Drugs
Three Challenges to the Specialty Business Model
Drug discovery companies have progressively tailored their pipelines to specialty therapeutic areas and smaller patient populations. However, the specialty business model has lately shown signs of strain and outright constraints in continued scalability. Emily O’Connor, Jillian Scaife, and Ryan P. Million outline three key challenges to the focus on specialty indications that are particularly critical for drug companies ...Read more

Regulatory
What Does ‘Off Label’ Mean in 2014?
Although drug companies make an enormous effort to obtain an FDA approval with a very specific indication, it always comes as a bit of a shock to learn that the medical community is not only using the product for that hard to achieve FDA approval — but also for several other non-approved indications. Tom Norton reports
...Read more

A solid health care investment. 50+% gross margins on products and services in which patients pay 100%? Consumers today have strong financial incentives to stay healthy to reduce their reliance on expensive treatment.  MMSN is a retailer of natural nutrition products & counseling services with a proven 24-year track record, strong financial performance, and 150+ franchised locations. They are expanding with qualified investors.Read more

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

How Digital Medicine Can Pinpoint Dosing Regimens to Optimize Drug Efficacy and Safety
On Demand Webcast
To Register free: www.pharmexec.com/pinpoint

//Global Blood Therapeutics (South San Francisco, CA)  named Ted W. Love, M.D., as CEO.//TetraPhase Pharmaceuticals (Watertown, MA) added Dr Jeffrey Chodakewitz to its Board of Directors.//Dr Annalisa Jenkins joined the Board of Directors of Biothera (Eagan, MN).//Ryan Weldon, Executive Vice President and Group Chairman of Valeant Pharmaceuticals International (Aliso Viejo, CA), is to leave the company.//

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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