Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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President Biden’s informal declaration that the COVID-19 pandemic is ‘over’ likely portends a formal end of the Public Health Emergency. But many of the US FDA’s COVID flexibilities don’t directly depend on that decision.
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.
The largest shareholder in major Japanese pharma firm Taisho, the founding Uehara family, intends to smooth the way to the restructuring and expansion of the business by acquiring and delisting all of its stock. The nearly $5bn size of the deal would makes it the biggest management buyout in Japanese corporate history.