Athenex expands its portfolio of T-cell receptor therapy technology under NCI license agreement; PDS Biotechnology accesses institute’s TARP tumor antigen technology.

After an extraordinary year that saw demand patterns and the supply chain upended by the COVID-19 pandemic, as well as a major merger that has transformed one of the global off-patent industry’s biggest players, Generics Bulletin’s Top 50 has once again seen significant changes.

The US FDA has set a PDUFA date for Hyloris’ Maxigesic IV 505(b)(2) NDA that is earlier than expected, following two positive Phase III trials, spurring hopes that the product could also see earlier commercialization and registration than previously anticipated.

There is momentum for Glenmark’s Ryaltris across new launch markets internationally, with FY2023 and FY2024 seen as important years for revenue scale-up. A partnered nitric oxide nasal spray for COVID-19 faces trial recruitment challenges in India but the firm hopes to be able to debut the product this year.