Keeping Track: FDA Clears Big Batch Of Products; 'Breakthrough' For Bristol HIV Drug
Executive Summary
The latest drug development news and highlights from our FDA Performance Tracker.
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Motif A Step Closer To Succeeding With Iclaprim After Phase III Success
Biotech firm hopes its once-shelved antibiotic will provide a therapeutic option for renally impaired patients with serious skin infections. With only one previous DHFR inhibitor ever approved, Motif also anticipates that iclaprim will offer an option for multidrug-resistant infections.
Keeping Track: Opana ER Abuse Deterrence Claim Withdrawn; Third Neulasta Biosimilar Submitted; Keytruda Cleared In Head And Neck Cancer
The latest drug development news and highlights from our FDA Performance Tracker.
Acer’s ‘Misunderstood Drugs’ Strategy Faces Regulatory Hurdles
Acer repurposes drugs with available data (like a 40-year-old European antihypertensive) into rare disease treatments (like Edsivo for vascular Ehlers-Danlos syndrome), but approval remains elusive, with a CRL for ACER-001 just as Edsivo is poised to enter a new clinical trial, armed with a new breakthrough designation. The Pink Sheet delves into regulatory history and strategy with CEO Chris Schelling.