Even with top-seller Biktarvy and its preventive therapy, Descovy, protected beyond this decade from generics, Gilead is investing aggressively in long-acting HIV candidates and its oncology pipeline.

Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.

Many of the same factors that held down large M&A transactions in 2021 carried over to 2022, which saw eight buyouts valued at $2bn+, headlined by Amgen’s $27.8bn purchase of Horizon.

Dong-A has achieved therapeutic equivalence for its ustekinumab biosimilar candidate DMB-3115 in clinical studies and now plans to file for marketing authorization for the product in both the EU and US.