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Diamyd Medical receives orphan drug designation

BY Alaric DeArment

NEW YORK The Food and Drug Administration has given orphan drug designation to a vaccine for Type 1 diabetes made by Diamyd Medical, the Swedish drug maker announced Wednesday.

The designation was given to rhGAD65, a drug in late-stage development for Type 1 diabetes with residual beta cell function. The FDA grants orphan drug designation to therapies for diseases that affect fewer than 200,000 Americans. The designation includes seven years’ market exclusivity rather than the customary five, funding for clinical studies, clinical design assistance and financial benefits such as FDA user fee waivers and tax credits.

The drug is undergoing a phase 3 clinical trial testing whether it can slow the destruction of insulin-producing beta cells, thus preserving the body’s ability to control blood sugar levels. The trial is still enrolling patients.

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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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