Paroxysmal nocturnal hemoglobinuria (PNH) – the rare blood disorder characterized by premature destruction of red blood cells – found itself in the spotlight, as did shares of Omeros Corp. (NASDAQ:OMER), which closed Oct. 15 at $10.42, up $6.32, or 154%, on word of an asset purchase and license agreement with Novo Nordisk A/S for zaltenibart (formerly OMS-906). Read More
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. Read More
Touting a science-driven, regenerative medicine-based treatment for hair loss “designed for the 21st century,” Pelage Pharmaceuticals Inc. drew a solid group of investors to the table in an oversubscribed $120 million series B round to fund an upcoming phase III program for PP-405, a topical small molecule targeting hair follicle stem cells. Read More
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. Read More
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. Read More
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. Read More
BioWorld Staff Writer Tamra Sami says it’s impossible to talk about changes to the biotech and med-tech landscape in Asia without discussing China, which is eclipsing the region. In the last two decades, China has shifted from imitator to innovator. Read More
Clinical updates, including data readouts and publications: Alzheon, Bioxcel, Candel, Celularity, Clover, Ionctura, Lexicon, Oticara, Pfizer, Remegen, Spyglass, Transcode, UCB, Vor. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Boehringer Ingelheim, Cytomed, Frontier, Johnson & Johnson, Nabla, Novo Nordisk, Quantro, Sumitomo, Takeda, TC. Read More
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. Read More
