Concerns over the impact of the proposed US BIOSECURE Act on the CRO and CDMO segments linger despite proponent Mike Gallagher’s plan to leave Congress soon. Which global manufacturers could gain, what determines a shift away from Chinese companies and how imminent is this? Scrip brings insights from industry feedback and other sources.

The arrival of an indigenous CAR-T cell therapy, a shot at GLP-1s and Parkinson’s disease, strides into adjacencies and an “easy revenue stream” formula for products set to lose exclusivity are some of the striking developments seen playing out in India. Industry leaders, including Cipla’s CEO, share their views with Scrip on some of the key trends in the first instalment of this two-part roundup.

CDER holds steady with a median time to approval of 11 months, while CBER posts 10.5 month median review time for its largest novel approvals class.

After China, India sees the arrival of a biosimilar to Novo Nordisk’s Victoza at a sharp discount, while action also appears to be heating up for the Danish firm's high-flying GLP-1, semaglutide, in both markets.