PHARMACY

Tufts University study says FDA reviews take an average of 8 years

BY Alaric DeArment

BOSTON Despite faster review by the Food and Drug Administration, a typical drug’s development cycle still takes eight years, according to a new report by Tufts University.

Between 2005 and 2007, the average time that the FDA took to review new drugs declined by slightly more than a year, but clinical trials take longer because the diseases that new drugs treat have become more complex, according to Tufts’ Center for the Study of Drug Development.

“Even though the total time to bring new drugs to market has remained essentially unchanged in recent years, drug developers are making progress,” Tufts CSDD director Kenneth Kaitlin said in a statement coinciding with the report, titled “Outlook 2009.” “Many factors are leading to longer clinical times, including a focus on complex diseases and more complicated development design protocols.”

Kaitlin said drug companies have taken steps to accelerate clinical development, including improving project management, expanding use of partnerships and licensing arrangements and increasing use of surrogate endpoints and adaptive clinical trials.

The report cited several near-term trends, including increasing globalization of preclinical and clinical trials to overcome local capacity constraints; continued shortages of experienced personnel, especially among upper-level management staff, hampering the FDA’s ability to fulfill its mandate; and an increase in approvals of monoclonal antibodies, or mAbs.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

PHARMACY

General Mills donates to charity and advertises through NBC’s ‘Biggest Loser’

BY Melissa Valliant

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.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

PHARMACY

Adventrx faces further workforce cuts

BY Alaric DeArment

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.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES