A US FDA review panel has given a lukewarm reception to molnupiravir, while Inovio is assessing its vaccine candidates against the new omicron variant, J&J nears a South African vaccine deal with Aspen, and South Korea brings in new COVID-19 measures. Meanwhile, Serum exports Novavax vaccine, Bharat looks at Covaxin in Omicron and Ocugen's Covaxin trial put on hold. 

Orphan drugs and COVID-19 products are among the latest filings under review by the European Medicines Agency for potential pan-EU approval.

Having completed a rolling review, the vaccine is now being evaluated by the European Medicines Agency for conditional marketing authorization under an accelerated timeline.

Notable third-quarter developments at major Korean pharma firms included the domestic reimbursement of Yuhan’s Leclaza, the approval of Hanmi’s Rolontis and SK Bioscience's approval filing for Novavax's COVID-19 vaccine for supply in the country, a roundup of results by Scrip shows.