FDA advisory committee recommends approval for Pfizer’s Sutent
NEW YORK — A Food and Drug Administration expert panel has given a favorable vote to a drug made by Pfizer for tumors, Pfizer said Tuesday.
The FDA’s Oncologic Drugs Advisory Committee voted 8-2 that Sutent’s (sunitinib malate) benefits outweigh its risks in the treatment of unresectable pancreatic neuroendocrine tumors.
While the FDA is not bound by advisory committee votes, it takes them into consideration when deciding whether or not to approve a drug.
FDA accepts regulatory application for Bio-T-Gel
LINCOLNSHIRE, Ill. — The Food and Drug Administration has accepted a regulatory approval application for a topical treatment for low testosterone made by Teva Pharmaceuticals and BioSante Pharmaceuticals, BioSante said Wednesday.
The two companies said the FDA had accepted their application for Bio-T-Gel and expected to complete its review by mid-November.
BioSante originally developed the gel and will receive milestone payments and royalties, and Teva will take responsibility for regulatory and marketing activities. The market for male testosterone products in the United States is more than $1.2 billion, according to BioSante.
Katz Group names new COO
TORONTO — Retail pharmacy network Katz Group Canada has appointed Frank Scorpiniti as COO.
With more than 20 years of retail pharmacy experience, Scorpiniti previously was SVP pharmacy operations at Duane Reade. Prior to Duane Reade, he held positions of increasing responsibility at Longs Drug Stores.
“Frank is a strategic thinker who has a passion for the retail pharmacy industry, and a proven ability to drive growth and performance within an organization,” stated Andy Giancamilli, CEO of Katz Group Canada. “We are confident that Frank’s leadership and experience will help enhance the customer experience across our network of corporate, franchise and banner pharmacies.”
The company also announced the appointment of Warren Jeffery as chief development officer, which Jeffery will assume in addition to his current role as interim chief merchandising officer. Reporting to Giancamilli, Jeffery will lead the company’s productivity and growth initiatives.
Katz Group Canada’s retail pharmacy network encompasses more than 1,800 chain, franchise and independent pharmacies across the country. Pharmacy banners include Rexall, Rexall Pharma Plus, The Medicine Shoppe, Guardian and I.D.A. Katz Group’s holdings also include Rexall Specialty Pharmacy, Rexall Direct, Rexall Health Services and ProPharm Limited.