Specialty Pharmacy

HERZLIYA, Israel — The Food and Drug Administration has given orphan drug designation to an investigational treatment for multiple myeloma, a blood cell cancer, that soon will enter mid-stage development.

XTL announced that the FDA had granted the designation to its recombinant human erythropoietin, or rHuEPO drug, for which the company soon will start phase-2 clinical trials.

The FDA gives orphan drug designation to treatments for diseases that affect fewer than 200,000 people in the United States per year.

SILVER SPRING, Md. — The Food and Drug Administration has approved an injectable gel for fecal incontinence, the agency said.

The FDA announced the approval of Oceana Therapeutics’ Solesta for patients who have involuntarily lost bowel control and for whom such therapies as diet change, fiber therapy and antimotility medications have failed.

Fecal incontinence affects more than 5.5 million Americans, according to the National Institutes of Health.

WOONSOCKET, R.I. — In a major win for its pharmacy benefit management business, CVS Caremark will handle the $3 billion mail-order and specialty prescription drug benefit for the Federal Employee Program starting January 2012, which, for the last three years, had been handled by rival Medco Health Solutions.

WOONSOCKET, R.I. — Many people who provide care and support to loved ones said they are more likely to be nonadherent to their own personal medication regimen than to neglect providing medications to those they are caring for, according to a new study by researchers at Harvard University, Brigham and Women's Hospital and CVS Caremark. Given this, there's a significant opportunity for pharmacists and doctors to identify and work with caregivers to improve medication adherence and chronic disease management.

WASHINGTON — California-based companies are developing nearly more than one-fifth of the drugs to treat some of the deadliest diseases in the world, according to an analysis by the drug industry lobby.

According to two Pharmaceutical Research and Manufacturers of America reports released this year, of the 1,186 drugs under development for heart disease and cancer, 243 were from California companies. These include 188-of-the-887 drugs for more than 20 types of cancer, and 55-of-the-299 drugs for heart disease and stroke.

NEW YORK — Several states are cutting funding to programs that provide HIV medications to people who can’t afford them in an effort to reduce spending, according to a published report.

The Washington Post reported that more than 8,300 people are on waiting lists to obtain antiretrovirals and other drugs that treat HIV, AIDS and related conditions. The Post article highlighted particularly large program cuts in Illinois and Georgia, as well as one proposed for Florida.

NEW YORK — The Food and Drug Administration has approved a Pfizer drug for treating pancreatic tumors.

Pfizer announced Friday the approval of Sutent (sunitinib malate) for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with locally advanced disease that can’t be removed through surgery. Pancreatic NET is a rare cancer reported in 2 million to 4 million people worldwide every year.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for hepatitis C made by Vertex Pharmaceuticals, the agency said Monday.

The FDA approved Incivek (telaprevir) to treat adults with chronic hepatitis C infection, particularly those who either have not received interferon-based drug therapy or who have not responded to prior therapies. The drug is approved for use with therapies that include ribavirin and peginterferon alfa.