Orexigen, FDA work out plan for path to approval of obesity drug
SAN DIEGO — Drug maker Orexigen Therapeutics said it had identified a "clear and feasible path" for the approval of its drug for treating obesity by working with the Food and Drug Administration.
The drug maker said this week that after meeting with officials from the FDA’s Office of New Drugs, it received a list of requirements from the agency about how to design a trial for Contrave (naltrexone and bupropion hydrochloride). The FDA, which declined to approve the drug in January, required that the trial be based on an intent-to-treat analysis, as well as criteria for interpreting the results at interim and final analyses that are similar to those applied to diabetes drugs.
"We have been working with clinical experts, advocacy groups and our partner, Takeda, throughout this process and are pleased with the feedback provided by FDA that identified a very clear and feasible path forward for this important therapy," Orexigen president and CEO Michael Narachi said.
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J&J HIV drug shows fewer side effects in trial data analysis
CHICAGO — A new study has found that a recently approved drug for HIV produces fewer unpleasant side effects during the first three months of therapy than the standard treatment, according to published reports.
MedPage Today reported that a study presented at the Interscience Conference on Anti-Microbial Agents and Chemotherapy found that Johnson & Johnson’s Edurant (rilpivirine) was easier to take than Bristol-Myers Squibb’s Sustiva (efavirenz).
The study found that use of Edurant resulted in fewer of the neurological side effects that patients experience when taking Sustiva, such as dizziness and abnormal dreams or nightmares, as well as rashes. The study was an analysis of data from the "ECHO" and "THRIVE" clinical trials, which enrolled a total of 1,368 patients.
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Nielsen unveils consumer shopping intentions for 2011 holiday season
SCHAUMBURG, Ill. — More than half of consumers plan to spend $500 or less this holiday season, according to Nielsen’s fourth annual holiday shopping sales survey.
Polling 25,000 U.S. households, about 52% of respondents reported plans to spend $500 or less. To save money, 40% of consumers reported plans to use coupons, while 20% of consumers already have started shopping.
What’s more, Nielsen said, when it comes to spending more this holiday season, affluent households will lead the way with modest increases in spending; although across all income levels, a mere 5% said they plan on spending more this holiday season, versus last year.
Big retail winners this holiday season, Nielsen projected, include online, club, dollar, toy and consumer electronics, as well as the following categories: gift cards, technology, vacations and toys.
“Nielsen expects the vast majority of consumers to be increasingly practical and focused on value this season,” Nielsen VP global consumer insights James Russo said. “More affluent consumers will drive spending, particularly in entertainment, vacations, toys and technology. This is a year to market early. Consumers are planning, creating lists and collecting coupons.”
Celebration for the holiday season makes lot of people use this as an excuse to go out and celebrate with their friends. But as theyr are preparing for this year’s holidays, many of them are making sure they have the cash they will be needing. Spending on holidays is already becoming a tradition though many are making ways to cut off some expenses and save money.
Local pharmacies are sometimes the only source of goods in the community. These shops could be easy, but they are expensive. Actually, purchasing at these shops could be twice as expensive.