Japan Earnings Roundup: Shinogi & Co.'s China Deal And Astellas Pharma Inc.'s Label Woes
This article was originally published in The Pink Sheet Daily
Shionogi rebounds from U.S. acquisition woes with C&O Pharmaceutical for China; Astellas ponders Mirabegron's reproductive warning.
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TOKYO - Astellas provided an update on development for blockbuster-hopeful mirabegron, and the main theme of its progress appears to be safety, or rather waiting for safety data. The company delayed U.S. and EU filings for the drug on regulatory requests for more safety data to assess cardiovascular risk. The company rescheduled mirabegron's FDA filing for 2Q/FY2011, and now everyone is waiting for full results on additional safety studies
SAN FRANCISCO - Big pharma may need to take a leap of faith to close deals in China, accepting greater risk in areas such as regulatory compliance and quality control, according to panelists during the 29th annual J.P. Morgan Healthcare conference in San Francisco
TOKYO - Shionogi, set on global expansion, has rejected initial plans to expand into Europe, instead turning to emerging markets in Asia