While biopharma companies across the world pulled out all the stops in 2021 to develop and manufacture COVID-19 vaccines and therapies, the pandemic highlighted supply chain weaknesses, spurring demands in many countries for more domestic manufacturing and less reliance on production in other countries.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biohaven, Cellular Biomedicine, Egetis, Enlivex, Genmab, Janssen, Novavax, Nurix, Nuvation, Pfizer, Therapeuticsmd, Veru.

U.S. regulators continued to be plagued in 2021 with accusations of politicization, most of which revolved around the expansion of the COVID-19 vaccine. Despite the Biden administration’s avowed commitment to follow the science in regulatory decision-making, the White House COVID-19 Response Team appeared to jump ahead of the science Aug. 18 when it announced the Sept. 20 rollout of a nationwide booster program for all adults. The program called for boosters to be administered eight months after the final dose of the vaccine. But just a few days earlier, government health officials had stressed that boosters were only needed for people who were immunocompromised.

LONDON – The confluence of Brexit and pandemic has hit regulators in Europe hard this year, with the workload of assessing COVID-19 vaccines and antivirals made all the more onerous by the loss of expertise suffered by both the EMA and the U.K. Medicines and Healthcare products Agency (MHRA) as their close relationship was severed.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioinvent, CASI, Cytokinetics, Junshi.

COVID-19 kept its grip on the world in 2021 as one new variant after another created new waves of infection, forcing regulatory officials to face ongoing political and logistical pressures in dealing with drug and vaccine approvals, mergers and acquisitions, manufacturing issues and demands for pricing reforms.