Specialty Pharmacy

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has granted orphan drug designation to an investigational treatment made by Edison Pharmaceuticals for rare diseases, Edison said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a dozen new generic versions of a drug used to treat breast cancer, the agency said Monday.

The FDA said that on Friday it approved versions of Novartis’ drug Femara (letrozole) made by Teva Pharmaceuticals USA, Dr. Reddy’s Labs, Sun Pharmaceutical Industries, Impax Labs, Endo Pharmaceuticals, Roxane Labs, Accord Healthcare, Synthon Pharmaceuticals, Natco Pharma, Indicus Pharma, Fresenius Kabi Oncology and Kudco Ireland.

INDIANAPOLIS — Cancer patients taking a drug made by Eli Lilly extended the amount of time they survived without their disease worsening, according to results of a study announced Sunday.

Lilly said results of the phase-3 “PARAMOUNT” study of the injected drug Alimta (pemetrexed) extended progression-free survival in patients with nonsquamous nonsmall-cell lung cancer. The study focused on continuation maintenance when one of the same drugs used as a first-line treatment for cancer is continued as maintenance therapy in an effort to control the disease.

WOONSOCKET, R.I. — CVS Caremark is enhancing its hepatitis C patient support program following the recent Food and Drug Administration approval of two new add-on therapies for hepatitis C, the company announced on Friday.

SILVER SPRING, Md. — A class of drugs commonly used to control blood pressure does not increase patients’ risk of developing cancer, according to the Food and Drug Administration.

NEW YORK — Legislation recently introduced in the Senate aims to address the issue of drug shortages.

The Preserving Access to Life-Saving Medications Act, introduced in February by Sen. Amy Klobuchar, D-Minn., would require drug manufacturers to inform the Food and Drug Administration when supplies of a drug may be running low, allowing the agency to inform hospitals and attempt to address shortages.

The bill currently has nine cosponsors and is under review by the Senate Committee on Health, Education, Labor and Pensions, according to congressional records.

NEW YORK — Bristol-Myers Squibb will collaborate with Roche to investigate the use of a combination of the companies’ drugs in patients with a deadly form of skin cancer.

The companies will conduct a phase 1/2 trial to test the safety and efficacy of BMS’ Yervoy (ipilimumab) in combination with Roche’s investigational drug vemurafenib in patients with melanoma that has spread to other parts of the body.

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.