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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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US FDA Panel To Weigh Safety, Tolerability Issues For One New, Two Approved Cancer Drugs

Oncologic Drugs Advisory Committee will review Spectrum’s poziotinib for use in targeted subset of patients with previously treated non-small cell lung cancer; ODAC also will consider next steps for two approved drugs with adverse survival trends in postmarketing studies: Oncopeptides’ Pepaxto in multiple myeloma and Secura Bio’s Copiktra for CLL/SLL.

‘A Forever Battle:’ Patent Reform, Launch Prices, And Where Lower Rx Price Advocates Will Go Next

Pharma’s opponents believe passage of the Inflation Reduction Act represents a momentum shift that will make it easier for politicians (even some Republicans) to take on the industry. They’ll need to count on that as they still have a long list of targets ahead on their lower-drug pricing agenda.

Finance Watch: Karuna, Cerevel And Others Benefit From Improving Biotech Sentiment

Good news in the biopharma industry and the US economy gave public drug developers the boost they needed to raise cash, including Karuna’s $750m offering. Private company financings slowed during the second week of August, but Prellis and Vector BioPharma raised venture capital.

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