India’s drugs regulator sets out plans for extensive digitization across the regulatory value chain and regulatory rationalization initiatives, while also “looking inward” to up its game as it tightens processes and enforcement. Audit action under the revised GMP norms is also being kicked off.

As India seeks to build on early gains in CAR-T cell therapy, experts call for ecosystem reform and also the need to demonstrate value to payer models of large economies to potentially back international reimbursements.

Sun’s CEO (North America) Abhay Gandhi tells Scrip how not many gave the firm a chance in the US with Ilumya, now with global sales of over half a billion dollars, and outlines prospects of deuruxolitinib for alopecia areata. India’s top-ranked drug maker also has an eye on China R&D assets.

Two top-50 Indian firms are speculated to be on the block with valuations expected to be richer than past multiples paid by buyers. A small, less known life sciences solutions provider is also keen to rope in a CDMO partner. Scrip speaks to a cross-section of experts on the action in deal street.

Biopharma experts including Nobel Laureate Professor Jack Szostak share their views on emerging innovation ecosystems and how India can get it right as it seeks to shift gears in R&D. Panelists noted that VC investments can be a mixed bag, called for regulatory vision that ensures safety alongside accelerated pathways like the LPAD in the US and also ‘open” AI platforms.

US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.