Thursday, July 30, 2015

FDA panel to review HPV vaccines by Merck, GlaxoSmithKline

Merck is seeking to expand the use of its Gardasil vaccine, while GlaxoSmithKline wants to gain initial FDA approval of Cervarix.

FDA panel to review HPV vaccines by Merck, GlaxoSmithKline


Wednesday will be a big day for GlaxoSmithKline P.L.C. and Merck & Co. Inc.

Both companies will go before an advisory panel of the Food and Drug Administration over two human papillomavirus vaccines to prevent cervical cancer. Certain types of HPV can cause cervical cancer; others can cause genital warts.

Big money is at stake. Merck has been selling its Gardasil for three years. In 2008, Gardasil generated worldwide sales of $1.4 billion.

GlaxoSmithKline would like to narrow Merck’s lead. Its Cervarix vaccine is now licensed in 95 countries, but earned only $231 million in sales in 2008. The U.S. regulatory process bogged down near the end of 2007, when the FDA said it would not approve the vaccine without data from a large study. That problem was resolved earlier this year.

As for Merck, it is seeking the panel’s approval to extend the use of Gardasil to boys and men to prevent genital warts and certain rare cancers.

The nine-member FDA Vaccine and Related Biological Products Advisory Committee will vote late in the day. If it recommends approval, the FDA usually follows that advice, but it is not bound to do so.

More on rebates

The federal “Cash for Clunkers” program spent $3 billion in about a month.

This fall’s planned rebate program for energy-efficient appliances is less than $300 million, and that had some readers worried they might miss out on getting a rebate for buying a new water heater, refrigerator, or other appliance.

The federal Energy Department has divvied up the funding based on state population. Pennsylvania will get $11.94 million in rebates, while New Jersey will get $8.33 million, and Delaware $838,000.

But each state gets to choose which appliances to include and the size of the rebate. The only thing that is standard is that the appliances must carry the Energy Star label.

We won’t know the full details until Oct. 15. But you can learn which appliances carry the Energy Star label at this government-operated Web site.

Just like the “Clunkers” program, you probably shouldn’t dawdle once Oct. 15 arrives. The Energy Department says the vast majority of the funding will be awarded by Nov. 30.

Inquirer Columnist
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Mike Armstrong blogs about Philadelphia corporations and business-related topics. Contact him at 215-854-2980. Reach Mike at

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