Coming in a few days under the wire, SuperGen Inc. said it has begun the rolling submission of a new drug application for Orathecin (rubitecan), an oral chemotherapy drug for refractory pancreatic cancer patients. (Bioworld Today)
The nitty-gritty of deal making and how strategy fits (or fails to fit) with business models became topics this month when ArQule Inc.'s much-hoped-for collaboration with an unnamed partner fell through, and the company said it was cutting its work force by a third and closing two facilities. (BioWorld Financial Watch)
As generic competition looms for its narcolepsy tablet Provigil, Cephalon Inc. said it has filed a supplemental new drug application seeking a broadened label that would include other sleep and wakefulness disorders. (BioWorld Today)
Talk about a shot in the arm (or a squirt up the nose): The ailing biotechnology sector got a boost last week when FDA advisory panels gave their blessings to a pair of potentially important but historically beleaguered drugs - Corixa Corp.'s Bexxar for non-Hodgkin's lymphoma and MedImmune Inc.'s FluMist, a nasal influenza vaccine. (BioWorld Financial Watch)
Meeting its self-imposed deadline by more than a week, Cubist Pharmaceuticals Inc. submitted the new drug application for injectable Cidecin as a treatment for complicated skin and skin structure infections caused by Gram-positive organisms, including Staphylococcus aureus. (BioWorld Today)