Indian officials may intervene to assist Ranbaxy with managing FDA ban
NEW DELHI, India The Indian government may become a player in the dispute between the Food and Drug Administration and Ranbaxy Laboratories, according to India’s Economic Times.
India’s government will intervene if the FDA refuses to lift its ban on more than 30 drugs from Ranbaxy’s Dewas and Paonta Sahib plants despite Ranbaxy’s efforts to fix the manufacturing problems the regulatory agency identified earlier this month.
Study questions Lipitor’s efficacy for women
NEW YORK A study published in the Journal of Empirical Legal Studies has shown that Pfizer’s blockbuster drug Lipitor does little to reduce the risk of cardiovascular problems in women.
The study was based on analysis of previous studies on drugs’ effects on cardiovascular health in men and women. Studies had shown that the reduction in heart attack risk was statistically significant in men who used Lipitor (atorvastatin calcium), but not in women.
“Our findings indicate that each year, reasonably health women spend billions of dollars on drugs in the hope of preventing heart attacks but that scientific evidence supporting their hope does not exist.”
Study shows long-term use of Avonex improves quality of life
MONTREAL Data from a study has shown long-term benefits among patients using Avonex to treat relapsing multiple sclerosis, drug maker Biogen Idec announced Thursday.
The study—called Assessment of Drug Utilization, Early Treatment and Clinical Outcomes, or ASSURANCE—represented a long-term follow-up of patients who participated in the Multiple Sclerosis Collaborative Research Group, the original phase III pivotal trial from which Avonex (interferon beta-1a IM) was approved.
“As a physician, my goal in treating my MS patients is to delay disability progression and help them maintain their normal lifestyle for as long as possible,” said Robert Bermel of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic. “This follow-up study identifies a group of patients who achieved benefits from long-term treatment and underscores the importance of starting on and continuing an effective therapy for MS.”