Specialty Pharmacy

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Actelion Pharmaceuticals for treating pulmonary arterial hypertension.

The agency announced the approval of Opsumit (macitentan) for adults with PAH, a chronic, progressive and debilitating disease caused by high blood pressure in the arteries that connect the heart to the lungs that can lead to death or the need for lung transplantation.

SILVER SPRING, Md. — The Food and Drug Administration is offering more than $14 million in grants for the development of products for patients with rare diseases, the agency said Monday.

DARMSTADT, Germany — The Food and Drug Administration has approved a pre-filled injector pen made by EMD Serono for infertile women, the company said Friday.

The drug maker — the U.S. subsidiary of Germany's Merck Serono, so-called to distinguish it from U.S.-based Merck & Co. — announced the approval of Gonal-f RFF Redi-ject (follitropin alfa), a disposable pre-filled injector pen intended for injection under the skin of a liquid formulation of Gonal-f RFF. The pens will be available in the United States in December.

ATLANTA — The Food and Drug Administration has approved a drug made by UCB for treating a form of arthritis.

The drug maker said Friday that the FDA had approved Cimzia (certolizumab pegol) for adults with active ankylosing spondylitis, though it declined to approve the drug for axial spondyloarthritis, or axSpA. UCB said it was working with the agency to determine how to get the drug approved for axSpA.

NEW YORK — As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

BAGSVÆRD, Denmark — The Food and Drug Administration has approved a new drug made by Novo Nordisk for treating hemophilia A, the Danish drug maker said.

Novo Nordisk announced the approval of Novoeight (turoctocog alfa), a recombinant coagulation factor VIII, for adults and children with hemophilia, a disease caused by factor VIII deficiency that results in uncontrollable bleeding.

NEW YORK — Deloitte plans to launch a data-mining system next month that it said would provide life-sciences organizations more access to the "front lines" of patient care and help them develop more personalized medicines based on clinical data more quickly and at a lower cost than before.

NEW YORK — Cancer-focused specialty pharmacy Onco360 has signed a contract with privately owned pharmacy benefit manager MedImpact Healthcare Systems, whereby the pharmacy will offer its services to the PBM's members.

The two companies said the partnership would offer MedImpact clients "a unique and effective solution for bending the cost curve," and was aimed at providing benefit payers with a proven and effective cancer pharmacy program that combines a cost-effective dispensing model with "clinical excellence."