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SVP product development and clinical operations

BY Alaric DeArment

HAYWARD, Calif. A company that develops drugs for inflammatory diseases has made a new executive appointment.

Anthera Pharmaceuticals announced that it hired Georgina Kilfoil for the newly-created position of SVP product development and clinical operations. Prior to working for Anthera, Kilfoil was a consultant at InClin and VP alliances and project management at Peninsula Pharmaceuticals.

“Georgina brings over 18 years of project management and clinical research expertise, making her a valuable and welcome addition to our senior management team,” Anthera president and CEO Paul Truex said in a statement.

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FDA committee won’t recommend approval for non-Hodgkin’s lymphoma treatment

BY Alaric DeArment

GAITHERSBURG, Md. A Food and Drug Administration advisory committee declined to recommend approval for a cancer drug made by Cell Therapeutics, the company announced Monday.

Cell Therapeutics said the FDA’s Oncologic Drugs Advisory Committee voted unanimously that data from clinical trials of pixantrone, a treatment for non-Hodgkin’s lymphoma, did not support its approval. Pixantrone would have been the first drug to treat relapsed or refractory NHL in patients who had received two or more prior therapies.

The FDA is not bound by the recommendations of advisory committees, and the agency is expected to decide whether or not to approve pixantrone on April 23. It does, however, take the recommendations into account when deciding whether or not to approve a drug, and the committee’s vote will likely diminish pixantrone’s chances for winning approval.

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Merck KGaA suspends cancer vaccine trial

BY Alaric DeArment

DARMSTADT, Germany A mid-stage clinical trial program to investigate a Merck KGaA cancer vaccine has been put on hold due to patients’ experiencing adverse side effects, the German drug maker announced Tuesday.

Merck KGaA, which is separate from the U.S.-based Merck & Co. and operates in the United States under the name EMD, said it temporarily suspended recruitment and treatment of patients in the phase 2 trial for Stimuvax (BLP25 liposome vaccine) after a patient with the bone marrow cancer multiple myeloma developed encephalitis. Merck said it made its decision under in alignment with a Food and Drug Administration hold placed on its investigational new drug application for Stimuvax.

The patient who developed encephalitis, a potentially fatal inflammation of the brain, was in an experimental arm of the clinical program and taking Stimuvax in combination with low doses of the cancer drug cyclophosphamide, which was not used in the other Stimuvax studies.

Another program, a phase 3 trial involving patients with non-small cell lung cancer and breast cancer, is affected as well, though Merck did not say exactly how.

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