PHARMACY

FDA expands age indication for Pfizer’s Prevnar 13 vaccine

BY David Salazar
SILVER SPRING, Md. — The Food and Drug Administration has expanded the age indication for Pfizer’s pneumococcal vaccine Prevnar 13. In addition to its previous indications for children aged 6 weeks to 17 years and adults over 50 years of age, the vaccine is now approved for use in adults 18 to 49 years of age. 
 
“This expanded age indication in adults 18 to 49 offers an important public health benefit as appropriate vaccination against S. pneumoniae is critical to reducing the risk of pneumococcal disease, including in those with immunocompromising conditions," Pfizer Vaccines chief medical and scientific affairs officer Dr. Luis Jodar, Chief Medical and Scientific Affairs Officer, Pfizer Vaccines.
 
The expanded indication fits closer with the 2012 Centers for Disease Control and Prevention’s Advisory Committee on Immunizations Practice recommendations for adults 19 years of age and older with immunocompromising conditions. 
 
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Report: FDA panel backs Amgen’s Humira biosimilar

BY DSN STAFF
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PhRMA names Stansel EVP, general counsel

BY David Salazar
WASHINGTON —  The Pharmaceutical Research and Manufacturers of America on Tuesday announced that James Stansel would be joining the organization as EVP and general counsel, effective Aug. 1. Stansel will oversee the organization’s legal department. 
 
Stansel has previously served as acting general counsel for the Dept. of Health and Human Services, working as the chief legal officer for it, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, the Health Resources and Services Administration and the National Institutes of Health. He was also the deputy general counsel and counselor to the secretary during his time at HHS. 
 
“With his deep legal expertise in complex health policy and regulatory issues, I am pleased to welcome Jim to the helm of our legal team,” PhRMA president and CEO Stephen Ubl said. “As our members push forward into new and exciting areas of research and development, Jim's experience working with industry and government will enable him to provide valuable counsel and guidance to our industry.”
 
Stansel joins PhRMA from Sidney Austin LLP,  where he is where he is co-head of the global life sciences team and partner in the health care, government strategies and food and drug groups. He has been recognized in The Best Lawyers in America  since 2011 for biotechnology and health care law, and is a member of Law360. 
 
“The biopharmaceutical industry's focus on saving, improving and sustaining lives through new treatments and cures is the backbone of today's health care system,” Stansel said. “I am excited to join PhRMA and its impressive legal team to support the industry as it continues to lead in and redefine innovation.”
 
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