Latest From Bridget Silverman
US FDA Revisits Gonorrhea Drug Development As Fast-Emerging Resistance, Preclinical Challenges Hold Back New Products
From animal models to non-inferiority margins, US FDA is seeking new perspectives on gonorrhea R&D, including how to incorporate extragenital infections into clinical programs.
Only two new antibiotics are in Phase III trials for gonorrhea: Entasis’ zoliflodacin, in collaboration with the Global Antibiotic R&D Partnership, and GlaxoSmithKline’s gepotidacin in partnership with the US Biomedical Advanced R&D Authority.
Keeping Track: US FDA Says Yes To AZ’s Farxiga In CKD And ADC’s Zynlonta, But No To Leo’s Tralokinumab, Chiesi’s Pegunigalsidase
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Alnylam’s second NDA for an RNA interference treatment for the rare disease rests on a comparison of vutisiran patients in the Phase III HELIOS-A study against an external control arm of placebo patients from Onpattro’s APOLLO study.
Patient-Focused Meeting On Vitiligo Could Galvanize R&D As The First Drug Candidates In A Long Time Advance
US FDA meeting directs attention to the vitiligo patient experience as a small group of potential treatments, led by topical Janus kinase inhibitors, are at the Phase II hinge point.
With 12 new BTDs announced so far this year, 2021 is on pace to match the COVID-19-depressed total number of designations in 2020. Here’s a breakdown of the candidates that have received the designation.