While an mRNA vaccine is still missing, 2021 saw Indian companies strike alliances, battle legal action and gain funding while the regulator played a crucial enabling role in the run up to the approval of eight COVID-19 vaccines from zero in 2020.

Heading into the J.P. Morgan Healthcare conference, pharmas have been focusing on discovery alliances. J&J’s deals look into novel tissue-targeted drugs, ionic liquid delivery technology and cancer vaccine R&D. Lilly teams with Entos on novel methods for delivering neurology drugs.

Janssen’s Troy Sarich outlines why it’s hard to emulate randomized controlled trials with real-world evidence studies, emphasizing that the two are “not in competition.” He also highlights the huge strides made by AI-driven technology firms to provide “research-ready” structured data and new game-changing advances in the area of health sensors.

Members of Congress, companies and government agencies want the Patent Office to change policies that they say impede generic drug competition. The latest effort is focused on PTO’s discretionary denial of inter partes review petitions, which is the subject of a bipartisan congressional letter and cert petition to the US Supreme Court.