Amgen releases clinical trial results for Aranesp
THOUSAND OAKS, Calif. Biotech company Amgen got lackluster results from a late-stage clinical trial of a drug in patients with Type 2 diabetes, chronic kidney disease and anemia.
The Thousand Oaks, Calif.-based company announced Wednesday that the phase 3 trial found no significant difference between patients with Type 2 diabetes and renal insufficiency receiving Aranesp (darbepoetin alfa) to treat CKD and anemia and those receiving placebo in terms of heart-related death, kidney-related death or chronic need for kidney transplants. The drug is already approved to treat the two conditions in non-diabetic patients.
CKD, also known as chronic renal failure, affects some 26 million Americans, according to the National Kidney Foundation.
NACDS utilizes Rapid Response program to dispute inaccurate assertions on drug importation
ALEXANDRIA, Va. The National Association of Chain Drug Stores implemented its Rapid Response Program, following a recent editorial on drug importation.
NACDS president and CEO Steve Anderson penned a response to the editor to the Delaware County Daily Times (Delaware County, Pa.) after an editorial ran on Aug. 19, which cited NACDS and asserted that chain drug stores should not be concerned about where prescription medications come from so long as they are less expensive for consumers to purchase.
“Pharmacies are convenient, accessible healthcare providers. Your neighborhood pharmacist counsels patients in obtaining the most cost effective and appropriate medications and therapies to improve their health outcomes,” Anderson wrote to the paper. “However, we do not believe that consumer safety should be compromised to achieve lower costs. Safety cannot be ensured in any system that allows for the personal importation of prescription medications. In addition, individuals who obtain prescription medications through a personal importation scheme do not have a licensed pharmacist available to consult with them about using the medications safely and effectively.”
The NACDS Rapid Response Program was created to address inaccurate or inappropriate portrayals of pharmacy, or call attention to an issue that impacts the pharmacy industry.
Tobacco Products Scientific Advisory Committee set in motion
ROCKVILLE, Md. The Food and Drug Administration has started exercising its newfound power to regulate tobacco.
The agency announced Tuesday the establishment of the Tobacco Products Scientific Advisory Committee as part of the implementation of the Family Smoking Prevention and Tobacco Control Act, which President Obama signed into law in June.
The committee will provide advice, information and recommendations to FDA commissioner Margaret Hamburg on health and other issues related to tobacco products. It will comprise 12 members, including nine medical, science and manufacturing technology experts and government officials who will each have a vote, and three industry representatives who will not.