AstraZeneca Hopes Imfinzi Breakthrough Get Can Burn Off MYSTIC Failure
Imfinzi becomes first cancer immunotherapy designated a breakthrough therapy for non-metastatic non-small cell lung cancer patients who have not progressed after platinum-based chemoradiation therapy, just days after announcing a missed primary endpoint in the first-line MYSTIC trial in metastatic NSCLC.
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Pfizer’s CEO will likely shed more light on the company’s on-off-on attitude towards its consumer health business, while Allergan will certainly have a lot of explaining to do regarding its Restasis patent protection strategy. Sanofi, Teva and AstraZeneca are also scheduled to report Q3 results in the coming days. Scrip outlines the key issues to watch for.
Keeping Track: Another Gene Therapy Approval, Several Priority Review Designations, And Many Resubmissions
The latest drug development news and highlights from our US FDA Performance Tracker.
The US has plenty of new pharma legislation, Europe has plenty of worries about EMA's Brexit move, pharmacy benefit managers give plenty more scrutiny to which products earn a place on formulary. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.