FDA advisory committee approves Sabril epilepsy treatment
CHICAGO An advisory committee of the Food and Drug Administration has recommended the approval of a drug by Ovation Pharmaceuticals to treat epilepsy, Ovation announced Wednesday.
The FDA Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously to recommend the approval of Sabril (vigabatrin) as an adjunctive treatment for adults with refractory complex partial seizures who have not adequately responded to anti-epileptic drugs. The FDA usually follows the recommendations of the advisory committee, though it is not required to do so.
“We are pleased with the advisory committee’s recommendation in support of the safety and efficacy of Sabril for the treatment of adult patients with refractory CPS,” Ovation president and CEO Jeffrey Aronin said in a statement. “For patients and caregivers who have found current anti-epileptic treatments to be inadequate, today’s positive FDA advisory committee recommendation is a significant milestone as they look to gain seizure control.”
General Mills donates to charity and advertises through NBC’s ‘Biggest Loser’
GOLDEN VALLEY, Minn. Major food manufacturer General Mills is backing NBC’s hit show “Biggest Loser” with its first-ever advertising slot for the show’s seventh season, which started Tuesday night. The spot will be viewed by approximately 8.6 million viewers, and fall 2008 showed a 2% rise in adult viewers ages 18 to 49, a demographic that advertisers often like to target. Nine other marketers from the show’s December season will also be advertising.
General Mills is also sponsoring a “Pound for Pound Challenge” in which the Cheerios and Progresso soup maker will be contributing 10 cents to Feeding America for every pound of weight loss pledged at biggestloser.com.
“This is our first integrated partnership of this kind,” said John Haugen, General Mills’ vice president of health and wellness. “We’re looking for a positive impact on all of our brands.”
Though popular (“Biggest Loser” averaged 8.9 million viewers last January), the show will be rivaling Fox’s incredibly successful “American Idol,” which begins next week and also airs Tuesday nights. Idol can bring in an audience of up to 25 million.
Adventrx faces further workforce cuts
SAN DIEGO After laying off 55 percent of its workforce, Adventrx is planning further reductions in its employees to extend its remaining cash reserves, the company announced Monday.
The company said that in the end, it will have 14 employees. It has also reduced and delayed spending on third-party consulting and vendor services, including contract manufacturing.
The remaining employees will evaluate options for the future and continue the company?s study of the drug candidate ANX-514 (docetaxel emulsion) and submitting an approval application for the candidate ANX-530 (vinorelbine emulsion).
“It’s never easy to let go employees, particularly those who have been with the company for many years and who have made contributions to the company,” Adventrx board chairman Jack Lief said in a statement.