Warnings
Chantix and Zyban Get Boxed Warnings
Two controversial drugs get some hefty warnings for mental health events including depression, suicidality, and hostility. Jury still out whether depression is due to treatment or smoking cessation.

Safety
FDA Panel Votes to Ban Narcotic Combo Drugs
For years, pain medications like Vicodin have come under fire for being addictive, but painkillers are now getting heat for their acetaminophen component, which could cause liver damage when taken in large doses. New rules could spell big changes for drug companies.

Legal
Abbott to Pay $1.67B in Patent Suit
J&J emerged victorious in a patent suit claiming that the technology behind Abbott’s blockbuster arthritis treatment Humira is too similar in design to J&J’s Remicade. The cost to Abbott: $1.67 Billion.

Regulatory
Building a Better Brief Summary
FDA wanted to find out what people really think of the risk information printed on the back of pharmaceutical advertising. No surprise: People tend to absorb far less information from giant blocks of text printed in drab language.

Technology
Calculating Risk
A risk-based approach to records and information management can be an integral part of the effort to reduce costs stemming from litigation.

Jonathan Andrus, vice president, clinical data management and regulatory operations at BioClinica’s eClinical service division, was elected as the Drug Information Association (DIA) North American special interest area communities eClinical chair // AbelsonTaylor appointed Jenny Drucker, Lauren Bo Cunningham, Yuliya Chepurnaya, and Tristen George to the position of senior art director //Cadence Pharmaceuticals appointed Scott Byrd vice president and chief commercial officer //Conner Strong received two Service Awards from New Jersey and New York’s bioscience associations for outstanding leadership and overall commitment to the industry // Valos, a CommonHealth business unit, promoted Suyen Segura to senior account executive and hired Stephen LaMond as senior vice president, enterprise lead; Diana Angione as senior editor; Karla Dougherty as senior copywriter; and Dana Meisberger, Catherine Fallone, and Scott Herget as traffic coordinators

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Free Educational Webcast Comparative Effectiveness

With President Obama calling for a national agency for comparative effectiveness and Congress introducing a bill in 2008 to set the stage at the federal level, no one doubts that comparative effectiveness is coming to healthcare. Join Tommy Bramley, senior director for Xcenda, and Tracy Foster, president for Lash Group on Thursday, June 25 at 2:00 PM (EDT) as they present on what these changes will encompass, how they will impact access to medications and what manufacturers can do to prepare.
Register Free at pharmexec.com/effectiveness

July 8 Clinical Study Data Integration - the Art and the Promise
11:00 AM EST

July 30–31 CBI’s 4th Clinical Supply Chain Management Conference, Princeton, NJ

September 21–24 5th Annual Process Excellence Week for the Service & Transactional World, Chicago, IL

October 5–7 BioNetwork 2009: The 7th Annual Pharmaceutical-Biotech Partnering Conference, Laguna Niguel, California

Biogen Idec and Acorda Therapeutics Announce Collaboration Agreement

GSK Says Asia Pacific Sales Could Double

European Approval for UCB's Cimzia

FDA Approves Feraheme to Treat Iron Deficiency Anemia