The US Food and Drug Administration evaluated Amgen’s (Thousand Oaks, CA) Complete Response submission for Prolia (denosumab) for treating postmenopausal osteoporosis, and classified it as a Class 2 resubmission. FDA set a Prescription Drug User Fee Act action date of July 25, 2010.
Avantium Pharma (Amsterdam), Beckloff Associates (Overland Park, KS), Cambridge Major Laboratories (Germantown, WI), and Xcelience (Tampa, FL) will hold a symposium, “Chemistry Playbook: Proven Modular, Expedited CMC Solutions from Carbon to Commercialization,” on Thursday Mar. 4, 2010, from 2:00-7:00 PM, in Waltham, Massachusetts. Beckloff Associates will provide insight on regulatory oversight, and Cambridge Major Laboratories will provide expertise on active pharmaceutical ingredient manufacturing. Avantium will offer analysis of solid-state characterization, and Xcelience will offer expertise on formulation development. Details for registering for the symposium may be found here.
Merck & Co. (Whitehouse Station, NJ) announced it would eliminate about 15,000 jobs out of its 100,000 employees worldwide over the next two years as part of a company restructuring following its 2009 acquisition of Schering-Plough (Kenilworth, NJ). Merck plans to eliminate approximately 2,500 vacant positions as part of the first phase of the restructuring program, according to a company release. The reductions will primarily come from the elimination of duplicative positions in sales, administrative, and headquarters organizations, and from the consolidation of manufacturing facilities and research and development (R&D) operations, the release said. The company expects the first phase of its restructuring program to yield 2012 cost savings of approximately $2.6 billion to $3 billion.
Pfizer (New York) will eliminate 72 employees at its Pearl River, NY facility. The employees are part of the facility’s chemical division and will lose their jobs by May 21, 2010.
The US Drug Enforcement Agency approved Pharmatek Laboratories’ (San Diego, CA) security and handling procedures. Pharmatek, a contract development and manufacturing organization, received approval to manufacture cytotoxic compounds at its San Diego facility.
Contract development and manufacturing organization Recipharm (Haninge, Sweden), which recently acquired Cobra Biomanufacturing (Keele, UK), has combined the biologics of both companies in Sweden. The integrated business will be known as RecipharmCobra Biologics and will operate as Recipharm’s specialist biologics division.
PhRMA (Washington) announced that Billy Tauzin, its president and CEO, will step down at the end of June. Tauzin, who has served in those roles for five years, will continue to serve as a consultant after a successor is found.
PPD (Wilmington, NC) named Lee E. Babiss executive vice-president of global laboratory services. He will be responsible for the strategic direction and scientific leadership of the company's bioanalytical, current good manufacturing practices, and global central laboratories, vaccines and biologics operations, and for BioDuro, the China-based drug-discovery company PPD acquired last year.