FDA committee recommends approval of Amgen’s Prolia
THOUSAND OAKS, Calif. A committee of scientists from the Food and Drug Administration has recommended approval of a new drug for treating bone loss.
Biotech company Amgen announced last week that the FDA’s Advisory Committee for Reproductive Health Drugs said Prolia (denosumab) should be approved as a treatment for postmenopausal osteoporosis and for treating bone loss in patients undergoing hormone ablation for prostate cancer following a review of safety and efficacy data from 30 clinical studies involving more than 12,000 patients.
At the same time, the committee declined to recommend approval for Prolia as a treatment for bone loss in women undergoing hormone ablation for breast cancer until additional data become available or for treating bone loss for low-risk patients in all three groups.
FDA advisory committees’ recommendations do not guarantee approval for a drug, but are taken into account when the agency makes its final decision.
Report: PhRMA backs healthcare reform
NEW YORK Most of the groups supporting President Obama’s healthcare reform plan have been patient advocates such as AARP, but the effort recently got some help from a different and traditionally conservative source: the drug industry.
Advertising Age reported Thursday that the Pharmaceutical Research and Manufacturers of America, the largest trade group for the brand drug industry, will set aside $150 million for an advertising campaign in support of healthcare reform, including TV ads in 12 key states, as well as radio and print ads. An executive from PhRMA told the advertising industry trade magazine that the ads would focus on ensuring that everyone has access to health insurance, including affordable co-payments and no denials based on pre-existing conditions.
The healthcare reform debate has turned contentious in recent weeks, with townhall meetings across the country disrupted by loud protests from opponents of reform who think it will harm healthcare more than it helps and will damage the economy.
QuikTrip opens second clinic for employees
KANSAS CITY, Mo. Convenience store operator QuikTrip Corp. has opened its second worksite health clinic for its employees in the Kansas City area, according to a local news report.
QuikTrip, which operates more than 500 convenience stores, opened its first worksite clinic two years ago at its headquarters in Tulsa, Okla.
The new 1,400-sq.-ft. Belton clinic is administered by Care ATC, a national provider of on-site medical clinics, and provides free services to the nearly 800 QuikTrip employees and their dependents in that area, the report stated.
The facility provides the same services as a primary care physician’s office and is staffed by a board-certified physician and others who are employees of Care ATC.
As previously reported by Drug Store News, worksite clinics are on the rise as employers increasingly look for ways to lower healthcare costs and bolster employee productivity.
It is estimated by Fuld & Company that there are some 1,200 firms currently operating on-site clinics, which, taking into account their multiple campuses and multiple clinics, results in an estimated 2,200 on-site clinics. That number could reach 7,000 by 2015.