Specialty Pharmacy

SILVER SPRING, Md. — An executive order from the Obama administration has spurred the Food and Drug Administration to address shortages of two cancer drugs and issue draft guidance for the industry to help prevent future shortages, the agency said Tuesday.

“I have 20 years in the retail sector, and I know that not every pharmacist can be a specialist in a retail environment. So we give the pharmacists a higher level of confidence by using technology to target specific [national drug codes]. If a limited-
distribution product or a specialty script that they either don’t stock or they have never seen before comes across the counter, the computer directs them to Hy-Vee Pharmacy Solutions.

ALTAMONTE SPRINGS, Fla. — A specialty pharmacy provider has begun selling a drug made by Pfizer for treating kidney cancer.

The company announced that it had launched Inlyta (axitinib), which the Food and Drug Administration approved last month for treating renal cell carcinoma in patients with advanced disease for whom first-line systemic therapy has failed. According to the American Cancer Society, 60,000 people in the United States are diagnosed with the disease each year, and 13,000 die.

NEW YORK — The Food and Drug Administration will review a regulatory approval application from Pfizer for a drug to treat an extremely rare and fatal degenerative disease, Pfizer said Wednesday.

Pfizer announced that the FDA had accepted its application for tafamidis meglumine, a treatment for transthyretin familial amyloid polyneuropathy. The disease, also known as TTR-FAP, is a fatal genetic illness that affects about 8,000 people worldwide and causes severe sensory loss, pain, weakness and organ dysfunction.

FRANKLIN LAKES, N.J. — Pharmacy benefit manager Medco Health Solutions has launched a medical benefit management program that it said would help control spending on specialty drugs, the company said.

PITTSBURGH — Mylan is changing the name of its branded specialty pharmaceutical business, the company said Wednesday.

The drug maker announced that it would change the name of Dey Pharma to Mylan Specialty. Dey makes treatments for respiratory diseases, psychiatric disorders and severe allergic reactions, including the EpiPen (epinephrine).

SILVER SPRING, Md. — Fake versions of a cancer drug made by Roche's U.S. unit have entered the United States, the Food and Drug Administration warned Wednesday.

The FDA advised healthcare professionals and patients that a counterfeit version of Genentech's Avastin (bevacizumab) had been distributed in the United States. The agency said the counterfeit versions carried Roche's logo instead of Genentech's and displayed batch numbers starting with B6010, B6011 or B86017.

CAMBRIDGE, Mass. — Drug maker Biogen Idec plans to spend up to more than $560 million to buy a company developing treatments for organ failure.

Biogen Idec announced that it would pay $75 million upfront, plus up to $487.5 million in milestone payments to acquire privately-owned biotech company Stromedix. Stromedix's lead drug candidate is STX-100, a monoclonal antibody entering phase-2 trials as a potential treatment for idiopathic pulmonary fibrosis, a disease that causes difficulty breathing due to scarring of the lungs and is almost always fatal.