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Genentech appeals FDA's plan to pull Avastin off market
NEW YORK — Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.
The San Francisco Business Times reported Tuesday that Genentech, part of Swiss drug maker Roche, is appealing the FDA’s plan to revoke approval for the drug Avastin (bevacizumab) as a first-line treatment for advanced HER2-negative breast cancer in combination with paclitaxel chemotherapy.
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Sandoz commences mid-stage trial for Rituxan biosimilar
HOLZKIRCHEN, Switzerland — Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.
Sandoz (pronounced “SAN-doh”), the generics arm of Swiss drug maker Novartis, announced the start of a phase-2 trial of rituximab, a biosimilar of Genentech’s Rituxan, used to treat such conditions as non-Hodgkin’s lymphoma and rheumatoid arthritis.