Bridget Silverman
Senior Editor
Latest From Bridget Silverman
Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas
The latest drug development news and highlights from the Pink Sheet’s US 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.
Keeping Track: US FDA Okays Alnylam’s siRNA Amvuttra, Alopecia Claim For Lilly’s Olumiant; Sierra Submits Momelotinib
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Clovis Withdraws Rubraca’s Original Ovarian Cancer Indication Shows FDA Emphasis On Survival Data
Clovis’ argument that an overall survival advantage seen for the chemotherapy control arm in the ARIEL4 trial is an artifact of the crossover design does not keep third-line and later ovarian cancer use on label; sNDA for first-line maintenance delayed.
Keeping Track: Pediatric Approvals, Seres Starts C Diff Submission, And BMS Pulls Reblozyl sBLA Before Possible CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Keeping Track: GSK’s Priorix Makes Three Novel US FDA CBER Approvals In 2022; Two CV Drugs Among Recent NDAs
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker