Content about Specialty Pharmacy

SILVER SPRING, Md. — The Food and Drug Administration is seeking comment from drug makers and others concerning formal meetings between the agency and companies looking to market follow-on biologics.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for multiple sclerosis made by Biogen Idec, the agency said Wednesday.

The FDA announced the approval of Tecfidera (dimethyl fumarate) capsules for adults with relapsing forms of MS.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.

Swiss drug maker Novartis announced the approval of Tobi Podhaler (tobramycin inhalation powder) for managing cystic fibrosis patients with Pseudomonas aeruginosa, or Pa bacteria, in the lungs.

SILVER SPRING, Md. — The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

SILVER SPRING, Md. — A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said Thursday.

LAKE OSWEGO, Ore. — Galena Biopharma has purchased rights to a treatment for breakthrough cancer pain from a Swedish drug maker, Galena said Monday.

Galena, which specializes in cancer-related drugs, said it acquired Abstral (fentanyl) sublingual tablets for sale and distribution in the United States from Orexo AB. Breakthrough cancer pain, or BTcP, affects between 40% to 80% of cancer patients, with reported episodes of four per day and a median duration of 30 minutes, according to Galena.

NASHVILLE, Tenn. — A record number of people were motivated to seek colon cancer screenings for a day last week, according to an organization focused on the disease.

StopColonCancerNow.com designated March 8 as National Colon Cancer Screening Day, motivating more 2,000 new patients to seek screenings for the disease. Experts recommend that anyone older than 50 years, as well as African-Americans 45 years and older and those who have a family history of polyps or colon cancer, get a colonoscopy.

NEW YORK — The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

ALEXANDRIA, Va. — A report on CBS' "60 Minutes" Sunday explored the aftermath of the nationwide outbreak of fungal meningitis linked to the New England Compounding Center that, according to the Centers for Disease Control and Prevention, has sickened 720 people in 20 states and led to 48 deaths.

SAN DIEGO — Early detection of a deadly brain infection that sometimes arises due to treatment of autoimmune disorders with immune-suppressing biotech drugs may improve survival, according to a new study.

The study, released Sunday and scheduled for presentation at the 65th annual meeting of the American Academy of Neurology in San Diego, which starts next Saturday, found that early detection of progressive multifocal leukoencephalopathy, or PML, may improve survival and disability levels.

ST. LOUIS — While the country's spending on specialty drugs increased by 18.4% in 2012, spending on traditional drugs fell for the first time in 20 years, according to a report by Express Scripts.

WASHINGTON — Employers that use multiple cost-management programs have a 50% lower specialty drug trend than those that don't use them, according to a new study by pharmacy benefit manager Express Scripts.

The study, presented Thursday at the National Business Group on Health's Business Health Agenda 2013 conference in Washington, was described as one of the first to examine the effect of multiple utilization management programs on the cost of specialty medications, which is expected to account for $1 out of every $4 spent on prescription drugs by 2014.