Keeping Track: Pfizer, AstraZeneca Get Complete Responses; FDA Sees Breakthroughs In Live Biotherapeutics
The latest drug development news and highlights from our FDA Performance Tracker.
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Even though both components are already marketed, firm might have to do another study for fixed-dose combination of DPP-4 inhibitor saxagliptin and SGLT2 inhibitor dapagliflozin.
Keeping Track: Lilly’s Mounjaro Enters Diabetes Market; Biogen/Eisai Lecanemab Leads Neuroscience News
CDER turned in its 13th novel approval of 2022 on Friday the 13th, and other drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Real-world evidence – and maybe even an opioid-sparing claim – will be part of Pfizer’s efforts to grow the CGRP space if its $11.6bn bid for Biohaven’s migraine assets goes through. Nurtec ODT (rimegepant) is the star, but pending fast-acting zavegepant could play a valuable supporting role.