Waxman asks Obama to look for alternative pathway for biosimilars
WASHINGTON With biosimilars legislation stalling in both houses of Congress, one of its chief proponents is calling on the Obama administration to let the Food and Drug Administration approve the legistlations with or without a regulatory pathway, according to published reports.
The Associated Press reported Monday that Rep. Henry Waxman, D-Calif., has asked the administration to look for ways to grant approval for biosimilars before either of the bills passes, to allow the FDA to approve them.
Waxman — who co-sponsored the Hatch-Waxman Act of 1984, creating a regulatory pathway for generic pharmaceutical drugs — introduced a bill on March 11 to allow biosimilars. That bill, H.R. 1427, would grant biotech companies five years’ market exclusivity before their products faced biosimilar competition. Waxman’s bill, with 11 co-sponsors and a companion bill in the Senate, competes with fellow California Democratic Rep. Anna Eshoo’s H.R. 1548, introduced six days after Waxman’s, which would grant up to 14 years of exclusivity to biotech companies and had 87 co-sponsors in the House as of Tuesday.
The Swan Princess 2 set to release this August
CULVER CITY, Calif. Sony Pictures Home Entertainment announced a sequel to the family-friendly movie, “The Swan Princess,” which will be available in DVD format Aug. 18.
“The Swan Princess 2: The Secret of the Castle,” continues the love story from its original with the reunion of Princess Odette and Prince Derek with their old friends Jean-Bob (the frog), Speed (the turtle) and Puffin (the bird) as they attempt to recover the Magic Orb from the evil Clavius.
Suggested retail price is $14.94 and rated G.
Also available from Sony Pictures Home Entertainment are “The Swan Princess Special Edition” and “The Swan Princess: The Mystery of the Enchanted Kingdom,” both in sparkling princess packaging.
Colorectal cancer rates increasing in young adults
NEW YORK Despite overall declining rates of colorectal cancer in the United States, recent studies show that the number of adults with colorectal cancer younger than 50 years old is increasing.
Rising obesity rates and changes in diet, including a higher intake of fast food and red meat, are said to be possible causes for the increase. According to a study posted in the June 2009 issue of Cancer Epidemiology Biomarkers and Prevention, further evidence is needed to confirm causes for the trend and to determine possible prevention and early detection strategies.
Since the mid 1980s, colorectal cancer rates in individuals 50 years and older have been decreasing, most prominently in recent years thanks to a rise in routine cancer screenings. The colorectal cancer rate has declined by 2.8% amongst men and 2.2% amongst women annually.
On the contrary, the rate of colorectal cancer found in individuals 50 years and younger, who do not generally go for routine screenings, is increasing. A study led by Rebecca Siegel at the American Cancer Society looked at data from 1992 to 2005 involving individuals 20 to 49 and found that incidence rates of colorectal cancer increased 1.5% per year in men and 1.6% per year in women. Young adults ages 20 to 29 years were found to face the most substantial increase in colorectal cancer.