Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Abbvie, Akamis, Blacksmith, Cingulate, Corcept, Denali, GSK, Johnson & Johnson, Legend, Krystal, Rocket.
Biopharma happenings, including deals and partnerships, and other news in brief: Boehringer Ingelheim, Cytomed, Frontier, Johnson & Johnson, Nabla, Novo Nordisk, Quantro, Sumitomo, Takeda, TC.
Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.
Antibody-drug conjugate specialist Tubulis GmbH has raised a hefty €308 million (US$356 million) series C to expand clinical development of TUB-040, positioning its lead program for use in additional indications and as an earlier line of therapy.
While the pace of executive orders (EOs) coming out of the White House has slowed, the Trump administration is still churning them out. As of the end of the third quarter, President Donald Trump had issued 209 EOs. Of those, BioWorld tracked 37 that directly impact drug and device R&D, regulatory burdens, pricing and market competition.
Government and market demands on companies and their pricing strategies have shifted dramatically in the past 10 years and the pricing landscape continues to change, creating uncertain ground beneath developers’ feet. At the BioFuture conference in New York, a panel discussed how big and small companies go about their pricing strategies and build educated guesses into how that strategy might work out in the market.
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