Drug pipeline 2Q21—accelerated approvals to the fore

Accelerated, rather than full, approvals were prominent. As usual, cancer registrations predominated—including Amgen’s Lumakras, a first-in-class covalent targeter of KRAS in lung cancer. The other big news was the controversial go-ahead from the US Food and Drug Administration (FDA) for Biogen’s Alzheimer’s monoclonal antibody (mAb) Aduhelm, which later was given a narrower label by the agency; the approval prompted calls by the acting FDA head for a federal investigation into interactions between the drug developer and regulators.

Para acessar a publicação na íntegra clique aqui

Fonte: 904 news Nature Biotechnology | VOL 39 | August 2021 | 897–907 | www.nature.com/naturebiotechnology