HOME >> MEDICINE >> NEWS
GlaxoSmithKline receives unanimous favorable recommendation by FDA Advisory Committee for Boostrix

PHILADELPHIA, PA, March 15, 2005 GlaxoSmithKline (NYSE: GSK) today announced that its booster vaccine candidate, BoostrixTM [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)] received a unanimous favorable recommendation from the Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration (FDA). Currently, there is no pertussis vaccine approved for use in the U.S. for children seven years of age or older. Immunity from childhood vaccination generally wears off after five to 10 years, leaving many adolescents susceptible to this highly contagious disease. If approved, Boostrix would add a pertussis component to the routine tetanus/diphtheria booster currently recommended for adolescents. The committee's favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for Boostrix.

Reported cases of pertussis have increased since the mid-1970s. According to the Centers for Disease Control and Prevention (CDC), there were almost 20,000 cases in 2004 the highest number of reported cases in more than 40 years. In addition, 39 percent of cases reported to the CDC in 2003 occurred in adolescents 10-19 years of age. Adolescents, in whom classic signs and symptoms of pertussis are often absent, may go undiagnosed and be the source of infection for susceptible infants and other family members.

"Pertussis is a serious and growing public health threat, and we are extremely pleased that the FDA Advisory Committee has provided a unanimous favorable recommendation for FDA approval of Boostrix," said Barbara Howe, M.D., vice president, Clinical Research and Development and Medical Affairs, Vaccines North America, GlaxoSmithKline. "If approved, Boostrix would add a pertussis component to the routine tetanus/diphtheria booster currently administered to adolescents a population in which there is a si
'"/>

Contact: Amanda Foley
919-483-2839
Cohn & Wolfe
15-Mar-2005


Page: 1 2 3 4 5

Related medicine news :

1. TB Alliance announces new drug discovery program with GlaxoSmithKline
2. Emory, GlaxoSmithKline, NIMH enter public-private partnership to develop new drugs for depression
3. GlaxoSmithKline Drug Discovery and Development Research Grant Program 2003
4. GlaxoSmithKline Drug Discovery and Development Research Grant Program 2003
5. GlaxoSmithKline Drug Discovery and Development Award 2002
6. GlaxoSmithKline Drug Discovery and Development Award 2002
7. UIC professor receives international humanitarian award
8. Mailman School of Public Health receives Manhattan Tobacco Cessation Center grant
9. Epidemiologist Trichopoulos receives $5.8 million Department of Defense Innovator Award
10. NYU Child Study Center receives grant from the American Red Cross September 11 recovery program
11. Northwestern Memorial Hospital receives $10 million commitment to support preeminent heart program

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of ... ElderCounsel, a national organization of elder law and special needs planning attorneys. “Membership in ... It also provides a forum to network with elder law attorneys nationwide,” said Somekh. ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading ... to advocate for action towards gender equality at their inaugural Summit in New York ... globe, and reached a social audience of over 3 million. To watch the Mobilize ...
(Date:10/13/2017)... , ... October 13, 2017 , ... ... and Agile Software Development, has been awarded a contract by the Center for ... Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies in a ...
(Date:10/12/2017)... CA (PRWEB) , ... October 12, 2017 , ... ... Cheng, are now treating sleep apnea using cutting-edge Oventus O2Vent technology. ... a serious sleep disorder characterized by frequent cessation in breathing. Oral appliances can ...
(Date:10/12/2017)... ... ... The American College of Medical Informatics (ACMI) will present the 2017 Morris ... of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium is taking ... in the field of medical informatics, this prestigious award is presented to an individual ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... , Oct. 10, 2017   West Pharmaceutical ... innovative solutions for injectable drug administration, today shared the ... ID Adapter for improving the intradermal administration of polio ... Skin Vaccination Summit in May 2017 by Dr. ... Polio Department, World Health Organization (WHO), and recently published ...
(Date:10/4/2017)... Oct. 4, 2017  South Korean-based healthcare product Development ... aide "cprCUBE" on Kickstarter. The device will educate the ... arrests with better efficiency compared to the dated and ... feedback on efficacy of the compression for a more ... a goal to raise $5,000. ...
(Date:10/2/2017)... Diplomat Pharmacy, Inc. (NYSE: DPLO ... LLC , and named its founder as Diplomat,s chief ... Tennessee , will operate under Diplomat subsidiary ... offerings for health care partners to include IT outsourcing, ... "In an interoperable world, technology delivers comprehensive insight ...
Breaking Medicine Technology:
Cached News: