¦ Biovail has received an approvable letter from the FDA for Ralivia ER (tramadol hydrochloride) extendedrelease tablets, a once-daily oral controlled-release pain medication. To maximize its opportunity in the U.S. market Biovail intends to outlicense sales and marketing rights to a strategic partner yet to be named. Tramadol is marketed as Ultram by Ortho-McNeil, and in several generic formualtions.
¦ Forest Laboratories said it has delayed development of lercanidipine, an experimental blood pressure medicine, because patients in clinical trials did not respond to the medicine as well as projected.
¦ The FDA has approved labeling showing that weight loss with Roche’s Xenical (orlistat) delayed the onset of type 2 diabetes in obese patients with impaired glucose tolerance (IGT or pre-diabetes).
¦ Novartis’ Femara (letrozole tablets) has been approved by the FDA for the extended adjuvant treatment of postmenopausal women with early breast cancer who have received adjuvant tamoxifen therapy for five years.
¦ The FDA has approved the new drug application for Aventis’ Allegra-D 24 Hour tablets (fexofenadine HCl 180 mg / pseudoephedrine HCl 240 mg), a formulation developed with aaiPharma and Osmotica Pharmaceutical.
¦ Eli Lilly has acquired exclusive worldwide rights to EMD 281014, an insomnia drug being developed by Germany’s Merck KGaA.The drug is in Phase I clinical testing.
¦ Shire Pharmaceuticals’ Fosrenol (lanthanum carbonate), a noncalcium, non-aluminum phosphate binder that reduces high phosphorus levels in end-stage renal disease patients has been approved by the FDA.
¦ Sanofi-Aventis and Altana have received an approvable letter from the FDA for Alvesco, an inhaled asthma treatment.Aventis, which will co-market Alvesco with Altana, filed with the FDA late last year.
¦ The FDA has approved Connetics Corp.’s Evoclin (clindamycin) Foam for the treatment of acne vulgaris. Evoclin (formerly referred to as Actiza) is the fourth brand for Connetics and its first product addressing the topical prescription acne market, which is valued at $1.2 billion-plus.
¦ Torre Lazur McCann this week named Marci Piasecki president of its East Hanover, N.J., office. Piasecki, a 10-year veteran of Torre Lazur McCann, spent the past two years at Hyphen, a unit of Omnicom, as executive vice president and director of client services.
¦ Arnold Worldwide named Tim O’Hare as senior vice president, group account director. O’Hare will be responsible for the Pfizer business and support new business development. O’Hare was a senior vice president at Foote Cone & Belding, where he developed campaigns for Amgen, Alcon and Lilly.
¦ The CementWorks named Peter Zamiska chief creative officer, a new position. Zamiska spent four years at MDC Advertising as a managing partner. He also held senior creative positions at Lavey/Wolf/Swift, FCB Healthcare, Lyons Lavey Nickel Swift and Robert Becker Euro RSCG. Todd Neuhaus was named senior vice president, creative director. Neuhaus was chief creative officer at Lyons Lavey Nickel Swift.
¦ Stephen A. Smith & Associates named Christine Moreira as senior art director. Moreira was an art director and senior art director at agencies including, Sudler & Hennessey, Robert A. Becker and Lyons Lavey Nickel Swift.
¦ Palio Communications named Stephen Toman as account director. He was vice president/director of project management at New World Health. Kathleen Sandwell was named account supervisor, she was a senior account executive at 1Health Communications.
¦ Communications Media Inc. (CMI) named Roxana Aldea media planner. She was at MPG as a media planner, most recently. Aldea will work on accounts for Bristol-Myers Squibb, AstraZeneca’s respiratory division and Giant Creative Strategy.
¦ APCO Worldwide, a global consultancy group, named Mik