PHARMACY

Study: Statin may lower cardiovascular disease risk in women

BY Alaric DeArment

ORLANDO A drug used to lower cholesterol also can reduce the risk of cardiovascular disease in women by nearly half, according to results of a new study.

Anglo-Swedish drug maker AstraZeneca presented results Tuesday at the annual scientific meeting of the American Heart Association of an analysis of clinical data from 6,801 women taking Crestor (rosuvastatin calcium). The data showed that women without cardiovascular disease — but at risk of developing it due to old age and sensitivity to the high-sensitivity C-reactive protein — who took 20 mg reduced their chances of heart attack, stroke, arterial revascularization, hospitalization for unstable angina and cardiovascular death by 46%.

“Nearly twice as many women die of heart attacks, strokes and other cardiovascular diseases as from all forms of cancer, including breast cancer,” AstraZeneca U.S. executive director for clinical development of Crestor Alex Gold said in a statement. “Women have been an underrepresented population in primary prevention statin outcome trials, and there has been limited evidence that women can benefit from statin therapy.”

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FDA approves fifth H1N1 vaccine

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Monday announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus, this one manufactured by ID Biomedical of Quebec, Canada, which is owned by GlaxoSmithKline.

As with the four previous H1N1 influenza vaccines licensed by the FDA on Sept. 15, ID Biomedical Corp. will manufacture its H1N1 vaccine using the established, licensed egg-based manufacturing process used for producing seasonal flu vaccine.

ID Biomedical’s H1N1 monovalent vaccine will be produced in multidose vials, in a formulation that contains thimerosal.

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PCMA responds to drug price increase

BY Alaric DeArment

WASHINGTON An article in The New York Times reporting that drug companies have dramatically increased the prices of drugs despite a decrease in the Consumer Price Index has prompted calls for biosimilars reform from an organization representing the nation’s pharmacy benefit managers.

The Pharmaceutical Care Management Association said that policy-makers should focus on creating a regulatory approval pathway for biosimilars instead of “shell games” to lower prescription drug costs. “Increased choice and competition generated by pharmacy benefit managers has been pivotal in driving prescription-drug trend to historic lows, while expanding consumers’ access to drug and pharmacy choices,” a statement by PCMA read.

The Times reported Sunday that while drug companies have promised to lower overall drug prices by $8 billion, wholesale prices of branded drugs increased by 9%, while the Consumer Price Index decreased by 1.3%.

The Pharmaceutical Research and Manufacturers of America criticized the article Monday, saying that drug companies determined drug prices independently based on such considerations as patent expirations and research and development costs, and that many PhRMA member companies had experienced flat or negative sales growth.

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