Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: 858, Annexon, Arbele, Complement, Intent, Invivyd, Moonlake, Plus, Revolution, RVL, Vanda, Vectory.
Annual biopharma financing values have fluctuated significantly over the past seven years, peaking during the pandemic-era surge in 2020 and 2021 before retreating in 2022. After rebounding to more than $102 billion in 2024, total financings declined in 2025 to $81.21 billion. Monthly totals in the year ranged from just under $3 billion (February and April) to more than $13.68 billion in October. December financings totaled $9.08 billion, comparable to November’s $10 billion collective raise.
Hisamitsu Pharmaceutical Co. Inc. President and CEO Kazuhide Nakatomi is leading a management buyout to take the company private, citing mounting drug pricing pressures and tougher listing requirements on the Tokyo Stock Exchange.
And another firm has reached a most-favored nation (MFN) pricing deal with the White House. Johnson & Johnson announced Jan. 8 a voluntary agreement with the Trump administration aimed at improving access and lowering prices for medications in the U.S., in exchange for exempting the pharma firm’s products from tariffs.
Newco Tecregen AG has raised CHF10 million (US$12.5 million) to advance a novel way of regenerating the thymus in order to boost T-cell production and stimulate recovery of the immune system following stem cell transplants and chemo- and radiotherapy.
Ollin Biosciences Inc. is gearing up for global phase III trials this year after disclosing favorable top-line results from its randomized, head-to-head phase Ib Jade study comparing OLN-324, a next-generation VEGF/Ang2 bispecific antibody, to Vabysmo (faricimab, Roche AG), which takes aim at the same targets. The drugs were tested in more than 160 patients with diabetic macular edema (DME) or wet age-related macular degeneration (AMD).