Current Editions
Tiny biotech’s experience raises questions about FDA’s rare disease policies
Grace Science says it has been shut out of plausible mechanism framework, denied flexibility on CMC requirements
Regulation
Data Byte
PRVs still pricey despite renewal
Two priority review vouchers have sold since the rare pediatric program was extended
Deals
In Chiesi’s biggest M&A deal yet, pharma buys HAE company KalVista
Italian company adds another rare disease asset via $1.9B takeout
A year after Tourette’s readout, Teva pays $700M up front for VC-backed Emalex
Seeing potential growth driver, pharma adds ‘NDA-ready’ asset for pediatric neurological disorder
BioCentury ISSN 1097-7201