Legal
Jury Sides with Family in Paxil Birth Defect Case
GSK is being ordered to pay $2.5 million in restitution to a Pennsylvania family. The firm was accused of not doing enough to warn consumers that taking the antidepressant Paxil, while pregnant, could lead to birth defects.

Patents
Sandoz and Shire settle Adderall XR Dispute
Shire Pharmaceuticals announced that it would allow Sandoz to market a generic version of its blockbuster ADHD med Adderall XR if it can clear FDA. But that’s a big if.

R&D
Biomarkers: Promises and Challenges
Jerome Wilson and Martin Nemansky explore some of the difficulties of implementing biomarkers during drug development.

Web Exclusive—Technology
Cut the Cord and Take to the Cloud
One feature that should be considered when looking for a new software-as-a-service (SaaS) system is multi-tenancy, which is a chief characteristic of a mature cloud computing application. Here’s what to look for.

Web Exclusive—Government
Action Amid Uncertainty: Preparing for Health Reform
As the health care reform debate continues to rage on Capitol Hill, pharma companies should be engaged in intense strategic planning for the future. Putting together a game plan now for the most likely reform scenarios will help companies to stay ahead of the curve.

Lundbeck, Inc. received the Marjorie Guthrie Leadership Award at the 13th Annual Huntington’s Disease Society of America (HDSA) Guthrie Awards Dinner in NYC // TGaS Advisors made the Philadelphia 100’s 2009 list of the fastest growing privately held companies in the Philadelphia region // Strand Life Sciences made Thon de Boer director of product management, software // Kendle appointed John Needham as executive director and global head, patient enrollment strategy // HC&B Healthcare Communications hired Joe Doyle as interactive services director // CommonHealth expanded its global presence with the opening of its office in Tokyo, Japan—CommonHealth Kyowa—and will be managed by Kazuo Okuhara // Cornerstone Pharmaceuticals added Robert A. Weinberg to its scientific advisory board // Soligenix appointed Robert J. Rubin, M.D., to its board of directors // Transdel Pharmaceuticals appointed Joachim P.H. Schupp, M.D., as chief medical officer // Takeda San Francisco appointed Michael Buckley, vice president of process sciences //

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October 20 Applying E-Commerce Tools to Support Discovery and Development of Medicines: Key Lessons and Learnings
Tuesday, October 20, 2009 at 11AM ET

October 28 Disclosure of Drug Promotion Expenses: How Automated Reporting and Master Data Management Can Improve Compliance and Lower Costs
Wednesday, October 28, 2009 at 11AM EDT

December 2 Risk, Reward and the Pharmaceutical Life Cycle: Managing Information as a Strategic Productivity Asset
Wednesday, December 2, 2009 at 11AM ET

Oct 20–21 CBI’s Leadership Summit on Global Interactions with Healthcare Providers, Arlington, VA

Nov 9–10 Annual Defining Appropriate and Effective Interactions with Thought Leaders and Key Opinion Leaders, Princeton, NJ

Dec 8–9 Forum on FDA’s Structured Product Labeling, Washington, DC

Onyx Pharmaceuticals to Acquire Proteolix

FDA Acts to Halt Marketing of Unapproved Codeine Sulfate Tablets

GSK Partners with UK Government and Wellcome Trust

Pfizer Settles License Agreement with Mylan