US FDA will continue to tie orphan exclusivity to uses or indications for which the drug was approved. Attorneys say this buys agency time to sort out complex policy and legal questions and continue to seek legislative fix. Additional litigation is also possible, as happened in Depomed case.

Scrip takes a look at the increasingly competitive landscape of Korean antibody-drug conjugate developers, which are now vying to catch up with their global rivals in the hot area.

Scrip wraps up major R&D and corporate developments for Korean biopharmas in 2022 and outlines what lies ahead for them in the new year.

Syngene’s COO, Mahesh Bhalgat, said the firm is better placed than some peers to serve clients for biologics-based advanced therapies and address the cost element for new modalities like mRNA. He also outlines the research, development and manufacturing services company's capabilities in oligonucleotide-based therapeutics, an area that's seeing growing interest.