FDA approves new use of Pfizer vaccine
NEW YORK — The Food and Drug Administration has approved a new use for a pneumococcal vaccine made by Pfizer, the drug maker said.
Pfizer announced the approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) for children and adolescents ages 6 years to 17 years for active immunization against the 13 Streptococcus pneumonia serotypes the vaccine covers. For this group, Prevnar 13 is administered as a one-time dose to patients who have never received it.
The approval was the result of an FDA review of a phase-3 trial of the vaccine in 592 older children and adolescents, including those with asthma.
FDA accepts application for Genzyme MS drug
CAMBRIDGE, Mass. — The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.
Genzyme, a division of French drug maker Sanofi, said the FDA accepted its application seeking approval for Lemtrada (alemtuzumab) for relapsing MS. The company expects the agency to decide whether to approve the drug in the second half of this year.
The company also announced early data about its oral MS drug Aubagio (teriflunomide). According to the company, more than 80% of MS specialists have prescribed the drug, while about 1-in-5 patients prescribed the drug had never received MS treatment before, and more than 50% of those taking it were most recently taking Teva Pharmaceutical Industry’s Copaxone (glatiramer acetate) or Biogen Idec’s Avonex (interferon beta-1a).
Supplylogix appoints Denys Ashby as director of retail chain sales
WESTLAKE, Texas — Healthcare supply chain software maker Supplylogix has appointed Denys Ashby as director of retail chain sales, the company said Monday.
Ashby, formerly head of retail chain pharmacy sales at pharmacy automation systems maker Innovation Associates, will lead Supplylogix’s sales and business development activity within the retail chain pharmacy market.
"Denys is a talented sales professional with a deep understanding of pharmacy operations and technology," Supplylogix president and CEO Mark Wilgus said. "His experience makes him ideally suited to help our pharmacy clients unlock value in their supply chains and achieve new levels of operational and financial success."