Shire files suit against Amneal, Sandoz over generic Vyvanse
DUBLIN — Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.
Shire said it has filed lawsuits in the U.S. District Court for the District of New Jersey against Amneal Pharmaceuticals and Sandoz. Amneal and Sandoz recently filed abbreviated new drug applications with the Food and Drug Administration to market generic Vyvanse (lisdexamfetamine), an ADHD drug.
Citing the Hatch-Waxman Act, Shire said that the FDA mustn’t approve the ANDAs for generic Vyvanse until the patents expire on Aug. 23, 2014, or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier.
Diplomat finds its patients are satisfied with pharmacy’s services
FLINT, Mich. — Just about everybody seems satisfied with Diplomat Specialty Pharmacy’s services, according to the company’s 2011 patient satisfaction survey.
Diplomat mailed the survey to 1,545 customers in May, of whom 463 responded. Of those respondents, 90% said Diplomat exceeded their expectations; 98% said it met their expectations; and 99% said they were satisfied overall with the specialty pharmacy provider.
Diplomat president and CEO Phil Hagerman said the results affirmed the provider’s patient-focused model.
“This type of customer-provided data reinforces the importance and value of our company approach, which includes direct outreach to patients to maintain our high adherence rates and our proprietary eNAV IT platform,” Hagerman said. “Equally important, the survey results reflect positive patient feedback at a time when Diplomat is on a major growth spurt, nearly 50% year over year.”
Study highlights foods, beverages that prompt weight gain
BOSTON — A new study that combined three separate cohorts conducted by researchers at the Harvard School of Public Health found that such lifestyle factors as diet may influence long-term weight gain.
The study pooled data from 120,877 U.S. women and men who were free of chronic diseases and not obese at the beginning of the study, with follow-up periods from 1986 to 2006, 1991 to 2003, and 1986 to 2006. Patients were followed up at four-year intervals, researchers said.
At the conclusion of the study, participants gained an average of 3.35 lbs. during each four-year period, which corresponded to a weight gain of 16.8 lbs. over the 20-year period. The biggest food culprits that were strongly associated with weight gain were:
Potato chips (1.69 lbs.);
Potatoes (1.28 lbs.);
Sugar-sweetened beverages (1 lb.);
Unprocessed red meats (0.95 lbs.); and
Processed meats (0.93 lb.).
These weight gains were inversely associated with the intake of:
Vegetables (−0.22 lbs.);
Whole grains (−0.37 lbs.);
Fruits (−0.49 lbs.);
Nuts (−0.57 lbs.); and
Yogurt (−0.82 lbs.).
The study noted that other factors, including alcohol intake, watching television and sleeping for less than six or more than eight hours also contributed to long-term weight gain. Physical activity, however, attributed to a loss in weight.
“These findings underscore the importance of making wise food choices in preventing weight gain and obesity,” said Frank Hu, professor of nutrition and epidemiology at HSPH and senior author of the paper. “The idea that there are no ‘good’ or ‘bad’ foods is a myth that needs to be debunked.”
The study was published in the June 23 edition of the New England Journal of Medicine.