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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

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OxyContin Reformulation Reduced Abuse Via Non-Oral Routes But Not Overall Abuse, US FDA Finds

FDA says it is unclear whether Purdue’s OxyContin abuse deterrent reformulation reduced opioid overdoses or had a net public health benefit. Briefing document for upcoming advisory committee meeting asks panel to discuss Purdue’s four postmarket studies but does not include voting question on possible change in labeling claims.

COVID-19 Vaccine Advisory Committee May Help Determine US FDA Approach To Licensure

The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.

Finance Watch: Five More Biopharma IPOs In The US Raise $624.7m

Public Company Edition: Outside the US, Zai Lab raised more in its recent Hong Kong initial public offering – $766.4m – than PMV, Prelude, Taysha, Graybug and Greenwich combined. Also, Gilead priced debt to fund its $21bn Immunomedics buy and ADC Therapeutics raised $204m.

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