FDA
Amphastar Goes Toe-to-Toe With Woodcock
After trying for six years to receive approval for a generic version of Lovenox, Amphastar has filed an official ethics complaint accusing CDER Director Janet Woodcock of favoring a rival generics company and stalling Amphastar’s blood thinner.

Marketing
Cardinal Health Goes Digital with New Marketing Tool
One of the largest pharmaceutical distributors launched a digital signage advertising solution for pharmacies to help promote drugs while patients wait for their prescriptions to get filled.

Regulatory
Feds Publicly Spank Bad Investigators
Think FDA isn’t paying attention to shady investigators? Think again. The agency is ramping up efforts to crack down on non-compliant investigators by debarring and disqualifying staff caught falsifying documents or breaking the law.

Global
UK: Swine Flu ‘Backlash’ Continues
Barely two weeks after their release, the pricing and profit margins of Big Pharma’s swine flu vaccines and anti-virals were the subject of the critical spotlight in the UK media.

Healthcare Reform
This Is Going to Hurt
There are several near-certainties for which pharmaceutical and biotechnology companies must be prepared as they develop forecasts and for the next five or six years.

Novo Nordisk appointed Per Falk, M.D., as vice president for clinical, medical and regulatory affairs for North America // Brookstone Pharmaceuticals appointed Philip Vogt as executive vice president, sales and marketing // Huron Consulting Group added Susan Sisskind Dunne and Chris A. McKeil as directors to the life sciences advisory services team // Qualicaps named Michael Sarno the new global CEO //  Medtipster appointed Jason A. Klein to president // Excaliard Pharmaceuticals named Jay Birnbaum to its board of directors as an independent board member // NovaBay Pharmaceuticals made Roy J. Wu senior vice president for business development // Cephalon appointed Craig C. Phillips to vice president and general manager of the oncology business unit // Oncothyreon appointed Diana Hausman, M.D., as vice president, clinical development // TSI Healthcare elected Esther E. Poza, M.D., to chief medical officer // Cook Associates Executive Search launched Cook’s new life sciences practice and hired Elizabeth McCabe as managing director // Manhattan Marketing Ensemble promoted Ashley White to senior account executive and hired Kelsey Fraser as assistant account executive // Physicians Interactive’s CEO and Vice Chairman, Donato J. Tramuto was named the 2009 PharmaVOICE “100 Most Inspiring Leaders in the Life Sciences Industry” //

September 10 An Evolving Standard for Success: Proving Product Value Through Comparative Effectiveness Data
Wednesday, September 10 at 11 AM EDT

September 14 Develop Competitive Advantage Through Business Analytics in the New Pharmaceutical Commercial Model
Wednesday, September 14 at 11 AM EDT

September 14–15 4th Annual Forum on Educational Grants for the Bio/Pharmaceutical Industry, Philadelphia, PA

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

September 30 Prix Galien 2009 Awards Ceremony, New York, NY

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

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

Lilly’s ImClone Makes NYC Its Home Base

Abbott Claims J&J’s Psoriasis Drug Infringes Patents

Wyeth Provides Regulatory Update on Prevnar 13