Batch of Japanese drug approvals, including for Taiho, Daiichi Sankyo and three for Novartis
Today, Taiho Pharmaceutical, the Japanese licensee of Switzerland-based Helsinn's second generation 5-HT(3) receptor antagonist palonosetron, gained marketing approval in Japan for the prevention of chemotherapy-induced nausea and vomiting (CINV) (including delayed phase) in patients with cancer.
Palonosetron will be marketed as Aloxi and the approval was based on the results of a large multicenter randomized double-blind clinical trial (PROTECT study) conducted in Japan which demonstrated the superiority of palonosetron versus granisetron in the delayed phase. Palonosetron has been developed by the Helsinn Group in Switzerland, world-wide licensor of the drug. The product is currently approved in 62 countries, including the USA (since 2003) and the European Union (cleared in 2005).
Manufacture of Rezaltas cleared
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