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Specialty Pharmacy

  • Biosimilars should take same generic names as branded counterparts, Hospira's Ramachandra says

    LAKE FOREST, Ill. — A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

  • Amgen acquires rights to Neupogen, Neulasta in 100 markets from Roche

    THOUSAND OAKS, Calif. — Biotech drug maker Amgen has acquired from Roche the rights to drugs used to boost the immune systems of cancer patients on chemotherapy in 100 markets.

  • NABP white paper stresses drug supply chain security

    NEW YORK — Keeping counterfeit and diverted drugs out of the U.S. drug supply chain will require closing vulnerable regulatory gaps that risk letting them in, according to a new report by the National Association of Boards of Pharmacy.

  • FDA awards more than a dozen grants for rare disease research

    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.

  • FDA approves Opsumit for pulmonary arterial hypertension

    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.

  • FDA approves UCB's Cimzia for ankylosing spondylitis

    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.

  • FDA approves new injector pen for Merck KGaA fertility drug

    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.

  • Hospira issues policy paper on biosimilar naming

    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.

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