Keeping Track: US FDA Approves Amgen’s Lumakras, Myovant’s Myfembree; New Claims For Biohaven’s Nurtec, BMS’ Zeposia
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Pfizer Gets First Approval Of Arena’s Etrasimod, In Ulcerative Colitis
Branded as Velsipity, the S1P modulator will compete directly against classmate Zeposia in UC and faces a crowded field of anti-TNFs and other types of therapy. Pfizer paid $6.7bn for Arena in 2021.
Amgen’s Lumakras: FDA Flags ‘Marginal’ Efficacy Results, Potential Systemic Bias In Lung Cancer Trial
Company seeks conversion from accelerated to regular approval for the first KRAS G12C inhibitor on the market, but the agency is asking its Oncologic Drugs Advisory Committee whether the progression-free survival primary endpoint in the CodeBreaK 200 confirmatory trial can be reliably interpreted.
Accord Sees Two Hybrids Endorsed By EU’s CHMP
The latest CHMP meeting has seen the EMA committee issue a positive opinion on two Accord hybrid medicines, Zolsketil (doxorubicin) and Camcevi (leuprorelin), at the same time as SERB’s generic amifampridine tablets were also endorsed.