Warning Letter Roundup & Recap – June 2022
No medtech-related warning letters were released by the US FDA in June.
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Shionogi is hoping to demonstrate the efficacy of its oral COVID-19 candidate Xocova through an appropriate primary endpoint in its Phase III trial, while the Japanese firm is also eyeing global expansion for the drug should a world-first domestic approval be granted.
Beiersdorf Is Having Record Year For Sun Care, Seeing China Recovery, But Full-Year Outlook Is Guarded
The Hamburg, Germany-based firm defied economic and political headwinds and China troubles in the fiscal 2022 first half to book organic net sales growth of 10.5% to €4.5bn worldwide. Despite optimism about China recovery, sun care, and its recent Chantecaille acquisition, Beiersdorf is projecting a slowdown in the second half in what remains a volatile operating environment.
Comfort with the initial approval based on inferred effectiveness may have made the current EUA process more palatable to US FDA officials but means there is a bigger gap in what’s known about the vaccine’s effectiveness overall.