Specialty Pharmacy

BASEL, Switzerland — The Food and Drug Administration has extended its regulatory review period for Novartis' new drug application for its once-daily, long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, as well as chronic bronchitis and/or emphysema, the drug maker said.

PRINCETON, N.J. — Bristol-Myers Squibb said its late-stage clinical trial for a cancer treatment, which currently is under review by the Food and Drug Administration, achieved its primary endpoint.

The company said its phase-3 trial for investigational compound ipilimumab, designed for previously untreated patients that were diagnosed with metastatic melanoma, improved overall survival. The study compared the combination of ipilimumab 10 mg/kg and chemotherapy (dacarbazine) with chemotherapy alone.

FRAZER, Pa. — Cephalon plans to acquire a privately owned company developing treatments for cancer, Cephalon said Monday.

The Frazer, Pa.-based drug maker said it would pay $225 million upfront for Malvern, Pa.-based Gemin X, and Gemin X stockholders would be eligible to receive up to $300 million in milestone payments related to products under development.

Gemin X specializes in cancer treatments that target and kill cancer cells. Its lead product is GX15-070 (obatoclax), currently in phase-2b clinical development as a treatment for small cell lung cancer.

MISSISSAUGA, Ontario — J. Michael Pearson has been appointed to chairman of the board at Valeant Pharmaceuticals, the drug maker said Tuesday.

Pearson, who is Valeant's CEO, will extend his contract with Valeant through February 2017, the company said.

Pearson replaces current chairman Robert Ingram, who remains on the board as an independent board director and lead director.

RALEIGH, N.C. — Patients with bleeding disorders could be eligible for a scholarship from a specialty pharmacy provider that specializes in treating them.

MedPro Rx announced Sunday that patients with such disorders as hemophilia and von Willebrand disease attending college and active in their communities could be eligible for its Education Is Power scholarship program.

CAMBRIDGE, Mass. — A drug under investigation as a treatment for a rare genetic disorder that causes abnormally high triglyceride levels in the blood has received orphan-drug designation from the Food and Drug Administration.

RIDGEFIELD, Conn. — A drug used to prevent stroke in patients with a form of atrial fibrillation has won preferred Tier 2 formulary status with pharmacy benefit managers Medco Health Solutions and CVS Caremark.

Boehringer Ingelheim Pharmaceuticals announced Monday that CVS Caremark and Medco had added Pradaxa (dabigatran etexilate mesylate) capsules to their commercial preferred drug lists, and Medco had added the drug to its Part D drug list.

ST. LOUIS — Drug maker Fleming Pharmaceuticals is increasing production of a drug for preventing thyroid cancer in response to the nuclear crisis in Japan.

The drug, ThyroShield (potassium iodide), is designed for use in nuclear emergencies and works by saturating the thyroid gland so that it can’t absorb radioactive iodine.