PHARMACY

ZymoGenetics announces launch of biosurgery unit headed by former Bayer leader

BY Alaric DeArment

SEATTLE ZymoGenetics plans to form a biosurgery business unit focused on the topical drug Recothrom Thrombin. It has hired Stephen Zaruby to head the division and serve as president of the company starting Jan. 2.

“Recothrom is an important asset with the potential to generate significant value, which we believe will best be realized by having a focused business unit,” ZymoGenetics CEO and board chairman Bruce Carter said in a statement. “With the addition of Stephen Zaruby and his proven expertise in building markets for hospital products, we?ve strengthened our management team overall and ofund the right person to lead our biosurgery business unit and build it into a valuable business.”

Previously, Zaruby served as VP and global head of the hospital and surgical business unit for hematology and cardiology for Bayer HealthCare Pharmaceuticals. At Bayer, he was the global strategic and United States operational head for hospital, surgical and related specialty products.

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Biosimilars could save significant amounts in healthcare costs, report concludes

BY Alaric DeArment

ARLINGTON, Va. A report by the Congressional Budget Office on the potential savings that biosimilars could create has drawn a response from the Generic Pharmaceutical Association.

“As Congress grapples with both the economic and healthcare crises facing our nation, the CBO Budget Options Report is concrete evidence that bringing safe, effective and affordable biogenerics to patients can result in significant healthcare cost savings for the federal government,” GPhA president and chief executive officer Kathleen Jaeger said in a statement.

“Specifically, the CBO Budget Options Report states that establishing a pathway for the approval of biogenerics will result in a multi-billion dollar savings potential for the federal government.”

Currently, the law does not permit the Food and Drug Administration to approve biosimilars, sometimes called biogenerics.

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FDA approves Genzyme drug to support bone marrow transplant recovery

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a drug by Genzyme that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer, according to an FDA statement Thursday.

Mozobil (plerixafor) is for use with the growth factor granulocyte-colony stimulating factor for treatment of adults with multiple myeloma or non-Hodgkin’s lymphomas.

Before receiving high-dose chemotherapy or radiation therapy, patients with these forms of cancer sometimes undergo a procedure known as apheresis, in which blood stem cells are collected and stored for infusion after therapy.

Patients receive G-CSF to help release and collect stem cells from the bone marrow. When used with G-CSF, Mozobil boosts the number of stem cells released from the bone marrow into the blood stream.

“Collecting the millions of cells needed for a bone marrow transplant can take hours or days,” director of the FDA Center for Drug Evaluation and Research’s Office of Oncology Drug Products Richard Pazdur said in a statement. “Mobozil provides a new therapeutic option for patients with certain types of blood cancers by increasing the number of stem cells collected in a given time period to be reinfused after therapy.”

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