Specialty Pharmacy

PITTSBURGH — A unit of generic drug maker Mylan has settled with Sunovion Pharmaceuticals over a drug used to treat chronic obstructive pulmonary disease and asthma.

Mylan announced Tuesday that it had reached a settlement in a patent litigation suit that Sunovion, which used to operate under the name Sepracor, had filed against Dey Pharma, now known as Mylan Specialty, concerning the drug Xopenex (levalbuterol hydrochloride).

NEW YORK — An experimental drug made by Pfizer for a rare and fatal neurodegenerative disease got a favorable vote from a Food and Drug Administration expert panel.

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 13-4 that the drug tafamidis meglumine would provide certain clinical benefits to patients with transthyretin familial amyloid polyneuropathy, or TTR-FAP, a hereditary disease that affects about 8,000 people worldwide. The FDA is not required to follow the recommendations of FDA advisory committees, but usually does.

WHAT IT MEANS AND WHY IT'S IMPORTANT — The $317 billion problem of medication nonadherence has many sources that often combine and overlap in complex ways. But fears of whether a drug is safe and will work are among of the most frequently cited reasons why patients don't take their drugs as prescribed, or don't take them at all.

SOUTH SAN FRANCISCO, Calif. — Two drug makers are looking to win approval for an experimental drug in patients with colorectal cancer that has spread to other parts of the body.

Onyx Pharmaceuticals announced that Bayer HealthCare had submitted a regulatory approval application to the Food and Drug Administration for regorafenib in patients with metastatic colorectal cancer.

SAN DIEGO — Findings from a new study indicate that more than half of the patients with ulcerative colitis who received subcutaneous injections of a drug used to treat autoimmune disorders responded to the treatment.

Johnson & Johnson subsidiary Janssen Research and Development announced results of a phase-3 trial of Simponi (golimumab) in ulcerative colitis patients whose condition had previously failed to improve with or who were intolerant to conventional drugs.

PITTSBURGH — A generic antiretroviral drug for treating HIV infection has won approval from the Food and Drug Administration.

Mylan announced Wednesday the approval of nevirapine tablets in the 200-mg strength. The drug is a generic version of Boehringer Ingelheim's Viramune. Mylan plans to begin shipping the drug immediately.

Various versions of the drug had sales of $116.6 million during the 12-month period ended in March, according to IMS Health.

TORONTO — Canadian retailer Shoppers Drug Mart is looking to acquire 19 retail pharmacies and three central fill pharmacies located in British Columbia, Alberta and Manitoba from Paragon for about $75 million in cash.

The completion of the transaction is subject to the approval of Paragon's shareholders, acceptance by the TSX Venture Exchange and certain other customary closing conditions. The transaction is expected to close in third quarter 2012.

NEW YORK — Federal and industry officials have been negotiating a federal track-and-trace system as part of a reauthorization of the Prescription Drug User Fee Act, according to published reports.