Regulatory and Washington

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.

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.

ALEXANDRIA, Va. — Legislation enacted in the state of Vermont, which establishes standards in the pharmacy audit process conducted by pharmacy benefit managers, has been applauded by the National Association of Chain Drug Stores.

RARITAN, N.J. — A Food and Drug Administration expert panel has recommended against expanding the approval of a Johnson & Johnson drug, the company said.

J&J subsidiary Janssen Research & Development said the FDA's Cardiovascular and Renal Drugs Advisory Committee voted against recommending approval of Xarelto (rivaroxaban) combined with antiplatelet drugs to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome.

ALEXANDRIA, Va. — Following the Senate’s defeat of a proposal that would have permitted “personal importation” of prescription drug medications, the National Association of Chain Drug Stores lauded the Senate’s decision to support patient safety.

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.

WASHINGTON — The generic drug industry has applauded the passage of legislation that will expedite the Food and Drug Administration's review of generic drugs and biosimilars, as well as enhance the agency's ability to inspect foreign manufacturing sites.