Successful Phase III Clinical Trial Results Out For NovoCure Novel Medical Device to Treat Recurrent Glioblastoma

Data from the first phase III clinical trial of NovoCure’s NovoTTF device for treatment of patients with recurrent glioblastoma (GBM) were presented as a late breaking abstract during the Neuro-Oncology session at the American Society of Clinical Oncology (ASCO) Annual Meeting. Study results show that NovoTTF, a portable medical device, may be as or more effective than the best available chemotherapies for GBM, but without the toxicity usually associated with cytotoxic or targeted treatments.

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FDA approves generic Camptosar in chemotherapy

Teva Pharmaceutical Industries has received FDA approval for the Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer’s chemotherapy agent, Camptosar(R) (Irinotecan Hydrochloride) Injection. Camptosar’s patent expired last month and the drug had annual sales of about $556 million in the U.S. in the twelve months ended December 31, 2007. The other companies that have received approval to launch the generic version of Pfizer’s chemotherapy agent are Actavis and APP Pharmaceuticals.

Orchid receives FDA nod for generic Kytril

Orchid Chemicals & Pharmaceuticals Ltd. has receiveOrchid Chemicals logod FDA approval for its Abbreviated New Drug Application (ANDA) for Granisetron Hydrochloride tablets in the 1-mg strength. Granisetron Hydrochloride tablets are a generic form of Roche’s Kytril drug, used to treat nausea induced by chemotherapy and radiation therapies. Orchid is the first Indian company to get an FDA approval for a non-antibiotic product.