The FDA approved OSI Pharmaceuticals and Genentech's Tarceva, a drug that extends survival in advanced non-small-cell lung cancer patients for whom chemotherapy has failed. The two companies will co-market the drug.
Tarceva is the second in a class of medicines called epidermal growth factor receptor (EGFR) blockers. Iressa from AstraZeneca was the first drug approved in this class.
Abbott Laboratories has added three new warnings to the label for its rheumatoid arthritis treatment Humira. Abbott said it received rare post marketing reports of an allergic reaction following the administration of the drug and warned Humira use should be discontinued if such a reaction occurs.
Novartis AG will pay Vertex Pharmaceuticals $10 million to develop its VX-322 cancer treatment. Novartis will receive worldwide development and commercialization rights to the drug. Ventex will receive further payments as clinical milestones are reached and royalties on sales.
The FDA's reproductive drugs advisory committee will meet Dec. 2 to review Procter & Gamble/ Watson Pharmaceutical's testosterone patch, Intrinsa – the first treatment filed for hypoactive sexual desire disorder.
Bristol-Myers Squibb Company and Medarex have joined forces to collaborate, develop and commercialize MDX-010, a fully human antibody investigational product targeting the CTLA-4 receptor. MDX-010 was developed by Medarex using its UltiMAb Human Antibody development system and is currently in Phase III clinical development for the treatment of metastatic melanoma.
Genmab A/S named Matthew Dean as vice president, sales and marketing. Dean, who was national business director at Ventiv Health U.S. Sales, will work in the Princeton, N.J., office.
Axonyx named Michael Griffith a director. Griffith is chairman of Centrue Financial Corporation, an Illinois state-chartered bank and was chairman and chief executive officer of ChiRex, a contract pharmaceutical research and development and contract manufacturer of active pharmaceutical ingredients.
Publicis Healthcare Communications Group named Lorraine Pastore president of its Nelson Communications division and Linda Szyper president of its Discovery Group.
Pastore's appointment follows the resignation of Fred Kellogg, former chief executive of Nelson, in October.
Pastore will also continue in her role as president of Life Brands, a healthcare marketing agency she founded in 2002. Szyper joined Discovery as managing director in 1999. Under her leadership, the firm doubled the size of its business.
Hyphen promoted Frank Saia to managing director, from director of technology. Saia's appointment follows president Marc Weiner's departure from the company to become president of Conectics and Qi, two CommonHealth units.
Advanstar Medical Economics Healthcare named Stephen Fields as director, strategic planning and development. Reporting to executive vice president, Annie Callanan, Fields will provide leadership in assessing, guiding and developing long-term strategic direction for the business, and will identify new business opportunities. Most recently, Fields was principle consultant for SCF Consulting, where he was engaged in business strategy development and implementation.
Advanced Health Media named Art Marchesini as senior vice president of sales and marketing. Marchesini previously was at Torre Lazur, where he was the president of medical education for the MPE Communications division of the organization.
Alliance Healthcare Information promoted Kristin Ortlieb to vice president, data and quality management. Ortlieb was director of database management and quality control.
PDI, a sales and marketing company, named Nancy McCarthy as executive vice president, human resources. McCarthy previously worke