Industry Watch [to 14 May 2016]

Industry Watch [to 14 May 2016]

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:: Pfizer Presents Results from Two Phase 3 TRUMENBA® (Meningococcal Group B Vaccine) Studies at the European Society for Paediatric Infectious Diseases Meeting
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced results of two Phase 3 studies demonstrating the immunogenicity of TRUMENBA® (Meningococcal Group B Vaccine) against invasive meningococcal B (MnB) strains representative of prevalent strains in the U.S. and Europe. The two studies, one in adolescents and one in young adults, met all primary immunogenicity endpoints. Also, secondary data presented show that TRUMENBA demonstrated similar immune responses against ten additional MnB strains, in both adolescents and young adults. The data, which continue to support the vaccine’s current safety and tolerability profile, were presented at the 34th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID 2016).

“TRUMENBA is designed to provide protection against serogroup B meningococcal disease,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc. “The Phase 3 data show that TRUMENBA elicits an immune response that is effective against prevalent meningococcal serogroup B strains in the U.S. and Europe, as well as 10 additional strains of this unpredictable disease. These data support the expectation that vaccination with TRUMENBA will help prevent this uncommon, but devastating disease in adolescents and young adults.”

These Phase 3 data support additional upcoming global regulatory submissions and the planned U.S. supplement to request the conversion of Accelerated Approval to Traditional Approval for TRUMENBA…

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:: PhRMA Member Companies Invested $58.8 Billion in R&D in 2015
WASHINGTON (May 12, 2016) — Pharmaceutical Research and Manufacturers of America’s (PhRMA) member companies invested an estimated $58.8 billion in research and development (R&D) in 2015, up 10.3 percent from 2014. New R&D data based on findings from the 2016 PhRMA annual member survey released today in the 2016 Biopharmaceutical Research Industry Profile and corresponding industry chart pack, Biopharmaceuticals In Perspective, highlight the wide-reaching impact of PhRMA member companies on the economy and biopharmaceutical innovation.