Dalzanemdor (SAGE-718) showed no difference from placebo in a Phase II Parkinson’s disease study, raising concerns about readouts later this year in Huntington’s and Alzheimer’s diseases.

In this second instalment on key trends playing out in India, Scrip talks to industry leaders on the marked shift in GMP norms that could potentially resize Indian manufacturing, large player interest in the CDMO space and M&A activity, where PE firms may be the “most aggressive” buyers.

Sun Pharma sees all time high market share and prescription trends in the US for key specialty products and remains upbeat on the prospects of deuruxolitinib for alopecia areata. The company also isn’t ruling out a potential comeback, at least not yet, for a higher dose version of the JAK1/2 inhibitor.

Only two breakthrough-designated novel agents remain on the US FDA drugs center’s 2023 user fee calendar, while CBER stacks up on vaccines and gene therapies under both BTD and RMAT programs.