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 submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Galderma, Intervene, Urotronic.

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

Theradaptive Inc. has received an FDA breakthrough medical device (BMD) designation for its Osteo-Adapt SP spinal fusion implant for transforaminal lumbar interbody fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis. Under the program Theradaptive will enjoy priority review for its spinal bone growth implant and interactive advice for continued development as well as clinical trial protocols during premarket review.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cooler Heads, Longeviti.