Regulatory and Washington

RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating internal blood clots, the company said.

J&J subsidiary Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) for treating deep-vein thrombosis and pulmonary embolism and to reduce the risk of recurrence of the clotting conditions after initial treatment.

The company said Xarelto was the first oral anticoagulant approved to treat DVT and PE without the need for injections or routine blood-monitoring.

ALEXANDRIA, Va. — Rep. Edward Markey, D-Mass., on Thursday announced plans to introduce legislation that would strengthen federal regulations of compounding pharmacies. The legislation is borne out of the recent meningitis outbreak linked to the New England Compounding Center, which is located in Markey's district, that has drawn much criticism on how regulators oversee compounding pharmacies.

WASHINGTON — The National Retail Federation and more than a dozen retailers on Thusday asked a judge to reject a proposed class-action settlement of a federal antitrust lawsuit filed against Visa and MasterCard because of credit card swipe fees. The NRF suggested the settlement would not bring credit card swipe fees under control and does not give retailers who oppose it an adequate mechanism to opt out.

NEW YORK — The Northeast is still recovering from one of the worst disasters it has ever faced. Many residents remain without electrical power, while others have lost their entire homes, businesses, workplaces and in a growing number of cases, their lives.

DUBLIN, Ohio — Cardinal Health Specialty Solutions on Wednesday announced that its specialty pharmacy, OncoSourceRx, has been awarded Specialty Pharmacy Accreditation from URAC, a Washington-based healthcare accrediting organization that establishes quality standards for the healthcare industry.

NEW YORK – Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

DEERFIELD, Ill. — Walgreens on Tuesday announced that it has formally set up a new company, jointly owned with Alliance Boots, as part of their strategic partnership’s synergy program.

The new company, called Walgreens Boots Alliance Development, will be based in Bern, Switzerland.

No other details were released. 

HOLZKIRCHEN, Germany — Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.

Sandoz, the generics arm of Swiss drug maker Novartis, said it had started enrolling patients for a phase-3 study of epoetin alfa, a biosimilar version of Epogen and Procrit, made by Amgen and Johnson & Johnson and used to treat anemia associated with chronic kidney disease.