CRN adds six members, including POM Wonderful and P&G
WASHINGTON — The Council for Responsible Nutrition last week named six new companies to its membership roster — voting members OmniActive Health Technologies, POM Wonderful, Procter & Gamble and Sensient Pharmaceutical Coating Systems; and associate members Akin Gump Strauss Hauer & Feld and the Natural Marketing Institute.
OmniActive Health Technologies employs proprietary or patented technologies and novel delivery platforms to improve functionality and stability of ingredients. OmniActive produces Lutemax 2020, lutein with enhanced levels of zeaxanthin isomers, for example.
POM Wonderful, is a leading pomegranate grower. As a vertically integrated pomegranate company, POM Wonderful grows and markets pomegranates and pomegranate-based products, and provides extensive funding to support scientific research on its products. POM Wonderful recently created an industrial ingredients division, which is focused on selling pomegranate-based ingredients to the food and dietary supplement industries.
Procter & Gamble fields such nutritional products as its line of psyllium fiber under its Metamucil brand and its probiotic supplement Align, which is aimed at supporting digestive health. In addition, P&G acquired the supplement manufacturer New Chapter in March, according to published reports.
Sensient Pharmaceutical Coating Systems develops and manufactures coating systems and provides color solutions for the pharmaceutical and nutraceutical markets.
Akin Gump Strauss Hauer & Feld is a law firm that provides a comprehensive suite of services for its clients worldwide. One of the firm’s specialties is food and drug law, with a focus on dietary supplements and regulatory strategies in the areas of labeling, advertising and manufacturing requirements.
The Natural Marketing Institute is an international strategic marketing consultancy specializing in health, wellness, sustainability and healthy aging since 1990. The company offers full-service consulting and market research services.
Gilead’s Truvada approved for PrEP
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug used to treat HIV for reducing the risk of HIV infection, the agency said Monday.
The FDA announced the approval of Gilead Sciences Truvada (emtricitabine and tenofovir disoproxil fumarate) in adults who don’t have HIV but are at high risk of becoming infected, also known as pre-exposure prophylaxis, or PrEP. For the new indication, the drug is designed to be taken once per day and combined with safer sex practices such as "consistent and correct" condom use, risk-reduction counseling, regular HIV testing and treatment of any other sexually transmitted infections; the drug is not meant as a substitute for safer sex practices.
"In the 80s and early 90s, HIV was viewed as a life-threatening disease; in some parts of the world, it still is," FDA Division of Antiviral Products director Debra Birnkrant said. "Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time. But it is still better to prevent HIV than to treat a life-long infection of HIV."
The approval was based on two clinical trials showing that daily use of Truvada reduced the risk of HIV infection by 42% in gay and bisexual men and transgender women and by 75% in HIV-negative people with opposite-sex partners who were HIV-positive.
Sanofi Pasteur begins shipping Fluzone in U.S. for 2012-2013 season
SWIFTWATER, Pa. — Sanofi Pasteur has begun shipping the first lots of its influenza vaccine for the 2012-2013 season.
The announcement follows the Food and Drug Administration licensure of the 2012-2013 formulation, the drug maker said. In addition to the strain change in the 2012-2013 vaccine, Sanofi Pasteur said its syringe presentations of Fluzone (approved for those ages 6 months and older) and Fluzone High-Dose (ages 65 years and older) vaccines have a new syringe cap that does not contain latex. All presentations of Fluzone vaccine have the designation "does not contain latex," which should mitigate concerns about use in patients with a latex allergy.
Sanofi Pasteur also noted that the Fluzone Intradermal vaccine — which was introduced in 2011 with limited availability — will be widely available for the 2012-2013 season. The formulation is recommended for those ages 18 years to 64 to years.
"This year, two new virus strains were recommended for the seasonal influenza vaccine formulation," Sanofi Pasteur VP and chief commercial officer Chad Hoover said. "It is a tremendous logistical challenge for public health to try to immunize everyone 6 months of age and older in the few months prior to influenza season. As the supplier of nearly half of the nation’s influenza vaccine, it was a critical challenge for us to be early to market so that healthcare providers had confidence in their supply of influenza vaccine. With the confidence of early vaccine delivery, healthcare providers can start immunizing sooner and commit to scheduling immunization clinics throughout the season."