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January 9, 2014 | ISSUE NUMBER 333 VOL 1

Forecast
US Pharma Challenges 2014
Pricing and personalized medicine are key themes shaping drug development and marketing in the U.S. in 2014, writes Jill Wechsler ...Read more

Technology
Bioelectronics: The Pulsing Pharmaceutical
Today there is promise in new approaches that rely on the “other language of biology,” using the human body’s own circuitry of cells and nerves to induce precisely targeted therapeutic effects against a range of debilitating disease. William Looney reports ...Read more

NSF Health Sciences (formerly Becker & Associates) helps clients meet and exceed FDA requirements for developing, testing and marketing innovative healthcare products. NSF offers quality services in the following practice areas:
  • Regulatory – Approval Strategy, FDA Interactions, 510(k), PMA, NDA
  • Compliance – Quality Systems, cGMP’s, Form 483s, Warning Letters
  • Trials – Preclinical and Clinical Study Design
  • Analysis – Due Diligence, Litigation Support
Learn More

Technology
The iPad’s Future in Pharma
Three years into the Apple-led tablet era, the iPad is still being used as no more than a glorified touchscreen. Gabriel Cangiano, Ron Kane, and David Windhausen look at the key role it can play in the future of pharma
...Read more

Events
Confessions of a Compliance Director
In anticipation of CBI’s11th Annual Pharma Compliance Congress later this month in Washington DC, PharmExec spoke with a compliance director at a mid-sized pharma about life under a CIA, and the potential trigger issues for 2014. In an effort to promote candor and avoid overly circumspect responses, we've agreed to withhold the interview subject’s identity
...Read more

Regulatory
Frontrunners in Innovation: Drug Approvals 2013
Trying to nail down the actual number of new drugs approvals in 2013 is like trying to swat a fly — it can be highly elusive. Safe to say, however, as 2013 drew to a close, the total number of new did not match 2012’s  high of 39. And yet, 2013 brought with it its own distinctions, including — launching new drugs at the fastest pace since the 1990s
...Read more

//Daniel D. Von Hoff, MD, was appointed to the Scientific Advisory Board of Lixte Biotechnology Holdings, Inc. (East Setauket, NJ).//Matthew Reaney joined ERT (Philadelphia, PA) as a scientific and regulatory consultant.//Cancer Genetics, Inc. (Rutherford, NJ) appointed John Pappajohn as its new Chairman.//CRO Ajinomoto Althea Inc. (San Diego, CA) named J. David Enloe Jr. as President and CEO.//The company also named Michael S. Weiss as a director and Co-Vice Chairman of the Company's Board of Directors.//

January 28–29, 2014: 11th Annual Pharmaceutical Compliance Congress
Washington, DC.


January 28–29, 2014: Real World Evidence
Philadelphia, PA.


March 5–7, 2014: 15th Patient Assistance and Access Programs
Baltimore, MD.


 
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