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Kaiser Daily Women's Health Policy
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Bioethics & Science | GlaxoSmithKline To Speed Development of Cervical Cancer Vaccine in Expectation of Stricter FDA Examination on Other Drugs, CEO Says
[Dec 06, 2004]

      GlaxoSmithKline CEO Jean-Pierre Garnier on Friday said that the company expects to speed development of its experimental cervical cancer vaccine Cervarix in anticipation of tougher regulatory scrutiny that could delay approval of some of the company's other experimental treatments, Bloomberg.com reports (Bloomberg.com, 12/3). According to a study published in the Nov. 12 issue of the Lancet, the experimental vaccine has proven to be 100% effective at providing protection against two strains of the sexually transmitted disease human papillomavirus that are known to cause the majority of cervical cancer cases worldwide. Both GSK and Merck, Sharp & Dohme, the U.K. subsidiary of pharmaceutical company Merck, have developed vaccines against HPV that are being tested in thousands of women around the world to confirm the effectiveness and safety of the vaccines. The companies are in a race to get their products approved. GSK plans to file for regulatory approval for Cervarix in Europe in 2006 (Kaiser Daily Reproductive Health Report, 11/15). Garnier on Friday said that Merck's September recall of the arthritis medication Vioxx likely will lead to a lengthier approval process for GSK's experimental COX-2 inhibitor. However, Garnier said he did not anticipate similar delays for the approval of drugs designed to treat or prevent cancer or other life-threatening conditions. GSK currently has 22 products in development, including Cervarix, which is expected to have a global market worth of about $100 billion. "Among all the opportunities and blockbuster drugs that are in the making, the one that is likely to surprise most people is our vaccine for cervical cancer," Garnier said (Bloomberg.com, 12/3).

For current women's health policy news, visit the National Partnership for Women & Families' website.


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