Content about Daiichi Sankyo

BETHLEHEM, Pa. — The Food and Drug Administration has approved a new Daiichi Sankyo manufacturing center that the company said would strengthen its domestic and global supply chain.

The Japan-based drug maker said it received FDA approval to package products at the plant, in Bethlehem, Pa. The company said it would be the first noncontracted U.S. manufacturing operation. The plant employs 39 people, and there are plans to hire more.

GURGAON, India — Ranbaxy Labs said Wednesday that it had resolved long-standing issues concerning two of its manufacturing plants in India with the U.S. government.

NEW YORK — While Indian generic drug maker Ranbaxy Labs is expected by many to launch a generic version of a cholesterol drug made by Pfizer later this year, it may have to sell its rights to it if it can't win Food and Drug Administration approval in time, according to published reports.

Citing Credit Suisse analysts, Bloomberg reported that the FDA may delay approval of Ranbaxy's version of Lipitor (atorvastatin), which would prevent it from marketing the drug starting Nov. 30, as it has planned to do.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a new means of administration for a drug made by Daiichi Sankyo, the drug maker said Monday.

Daiichi Sankyo announced the FDA approval of Welchol (colesevelam hydrochloride) for oral suspension to be mixed with fruit juice or diet soft drinks. The drug, used to improve blood-sugar control and cholesterol levels in patients with Type 2 diabetes and high cholesterol, received approval in 2009 for mixing with water.

PARSIPPANY, N.J. — A drug made by Daiichi-Sankyo was safe and effective in maintaining reductions in blood pressure in older patients, according to a new study presented at the American Society of Hypertension’s 26th annual meeting in New York.

The “TRINITY” study of Tribenzor (olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide) showed the drug was well-tolerated and effective in patients ranging in age from younger than 65 years to older than 65 years, after a year.

PARSIPPANY, N.J. — Daiichi Sankyo's SVP commercial operations has taken on a new role at the company.

The drug maker said that John Gargiulo would become president and CEO, effective Monday, following the retirement of current leader Joseph Pieroni.

Gargiulo has been with Daiichi Sankyo since its inception in 1996. In addition to his role at the company, he currently serves on the board of directors of the Pharmaceutical Research and Manufacturers Association, as well as the National Pharmaceutical Council.

MORRISTOWN, N.J. — Watson Pharmaceuticals is seeking regulatory approval for a generic drug for high cholesterol.

Watson, through subsidiary Watson Labs, said it applied for approval of a generic version of Daiichi Sankyo’s and Genzyme’s Welchol (colesevelam hydrochloride). The drug, a powdered oral suspension, is used to reduce “bad” LDL cholesterol in patients with primary hyperlipidemia, either alone or in combination with a statin.