Keeping Track: US FDA Clears New Uses For Incyte’s Pemazyre, AbbVie’s Imbruvica; Minerva Seeks First Negative Symptoms Claim In Schizophrenia
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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The US Court of Appeals rejected all arguments brought by Alvogen and Natco in their appeal against an unfavorable lower court Imbruvica (ibrutinib) ruling, leaving the ANDA sponsors facing a significant wait to potential approval and launch.
The firm’s potential new therapy for the negative symptoms of schizophrenia is now in the hands of the US Food and Drug Administration – some have concerns over whether the supporting data will be enough.
Iovance has seen its share price collapse after releasing data from a second melanoma patient cohort – but is confident its potential first-in-class therapy is approvable.