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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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Biosimilars For Avastin, Herceptin To Cap Off Busy July For ODAC

Pfizer's Mylotarg attempt to return to US market is first up for FDA's Oncologic Drugs Advisory Committee, followed by Novartis's CAR-T therapy. ODAC will then give half-day review to Amgen's and Mylan's biosimilars, suggesting FDA is increasingly comfortable with the product category.

Cambridge Vision Achieved, AstraZeneca Looks To Realize ‘Pipeline 2’ Ambitions

Having achieved a turnaround in its R&D and commercial fortunes, AstraZeneca’s hopes the opening of a new research center will herald its next wave of novel therapies.

Pfizer/BioNTech’s Comirnaty Supply Agreements Unaffected Despite EU Green Light For Under-12s

Pfizer and BioNTech’s Comirnaty supply under existing agreements will continue as planned despite anticipated expansion into a new child sub-population in Europe.

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