Sanofi Pasteur submits supplemental application to FDA for flu vaccine
SWIFTWATER, Pa. Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, on Friday announced the company has submitted a supplemental application for licensure of its influenza A(H1N1) 2009 monovalent vaccine to the Food and Drug Administration.
Responding to recent recommendations by the FDA, the company’s supplemental application requests the FDA’s evaluation of the influenza A(H1N1) 2009 strain change, which is expected to expedite the licensure process for the pandemic vaccine.
“Filing this application is consistent with our commitment to work collaboratively with public health officials in producing a vaccine against the influenza A(H1N1) 2009 virus,” stated Wayne Pisano, president and CEO of Sanofi Pasteur. “It is essential that we pursue the vaccine licensure pathway made available to us, while at the same time, continue the important clinical studies of our vaccine.”
The supplemental application follows recent recommendations by the FDA to evaluate the influenza A(H1N1) 2009 monovalent vaccines using the same regulatory process by which it approves new viral strains contained in the annual seasonal influenza vaccines.
While these strain change supplements are not required to be supported by new clinical data, immunogenicity and safety data will be made available through clinical studies. Sanofi Pasteur will test the immunogenicity and safety of its influenza A(H1N1) 2009 monovalent vaccine through clinical trials in the U.S., which began Aug. 6. The planned clinical trials will consist of approximately 2,000 subjects and will also evaluate the safety and potential benefits of adding an adjuvant to the pandemic vaccine.
Home Diagnostics, Inc. reports spike in retail sales
FORT LAUDERDALE, Fla. Home Diagnostics, Inc. on Thursday realized a 45.2% increase in retail channel sales for the second quarter ended June 30, the company announced.
Retail sales were driven by the continued national rollout of the TRUEresult and TRUE2go blood glucose monitoring systems and the expanded product portfolio at Walmart. Though total revenue for the second quarter was $32.7 million, a decrease of 2.1%. International sales decreased 22.3%, reflecting lower sales in Latin America following the company’s decision to limit its exposure in that region due to poor economic conditions.
“We are particularly pleased with our domestic sales which grew during the quarter, outpacing the reported results of the majority of our branded competitors, which reported sales declines for the quarter,” stated Joseph Capper, president and CEO of HDI. “This reflects our position as a leading provider of value-priced, high-quality blood glucose monitoring products. We achieved 45% growth in our retail channel, driven by strong reception of our new products, TRUEresult and TRUE2go, as well as organic growth of existing products with our major retail partners.”
The Best for Babes Foundation set to release new pro-breast-feeding ad
LITTLE SILVER, N.J. The Best for Babes Foundation on Thursday will release a provocative new ad to coincide with World Breastfeeding Week, which takes place Aug. 1 to 7 in 150 countries.
The ad is intended to relay that breastfeeding save lives and expecting moms need more help and to be better prepared around breastfeeding. The ad urges expecting mothers to find a support group, get expert lactation help, and choose hospitals and physicians that are breastfeeding friendly.
Best for Babes co-founders Bettina Forbes and Danielle Rigg contend that women are being pressured to breastfeed, but prevented from succeeding. “Moms don’t need more pressure, judgment or guilt,” Forbes stated.
The new ad will run in the Fall/Winter issue of Mom & Baby magazine and online through TheFamilyGroove.com and various blogs. Frank About Women, a marketing-to-women communications firm, donated the six-figure ad campaign.
The campaign is being backed by a growing corporate alliance of companies, including Earth Mama Angel Baby, My Brest Friend, Hotslings, Pumpease and My Baby Experts.