U.S. FDA approvals in 2022 are down by 31.3% compared with last year and clearances for new molecular entities are at the bottom of all recent years. As of Dec. 20, the agency had approved 143 drugs and biologics in 2022, including supplemental filings, just slightly higher than the 138 approvals in 2016, but far behind the 208 approvals recorded in both 2021 and 2017.

Tucked into the 4,155-page, $1.7 trillion spending bill for fiscal 2023 that U.S. President Joe Biden signed into law Dec. 23 is a small provision that may have outsized impact on future biosimilar and other drug development. Championed by lawmakers on both sides of the political spectrum, the provision modernizes the data that can be used to support drug development, including alternatives to animal studies.

Despite pipeline setbacks in 2022, TG Therapeutics Inc. ended the year on a positive note, with U.S. FDA approval of its glycoengineered CD20 monoclonal antibody, ublituximab, in relapsing multiple sclerosis (MS). Branded Briumvi, the drug is set to go up against approved anti-CD20 antibodies Kesimpta (ofatumumab, Novartis AG) and Ocrevus (ocrelizumab, Roche Holding AG).

Although the war is still raging in Ukraine, Russia is marching forward with asserting its regulatory framework on health care in the parts of Ukraine it’s claiming as the spoils of the war it started 11 months ago.

The Australian government delivered an early Christmas present to the biopharma industry in the form of a new National Medicines Policy giving voice to major industry goals – among them a clear vision to “achieve the world’s best health, social and economic outcomes for all Australians through a highly supportive medicines policy environment.”