Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alpha Cognition, Apellis, Calidi, Eisai, Intrabio, Johnson&Johnson, Lithea, Metriopharm, Nektar, PTC, Sarepta.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bausch, BMS, Cingulate, Durect, Eli Lilly, Exelixis, Formation Bio, Imidomics, LTZ, Neurox, Quion, Relief.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acumen, Aim, Alfasigma, Alterity, Alzcure, Celcuity, Cervomed, Cognition, Eli Lilly, Fulcrum. Nkgen, Recognify, Servier, Taran, Urogen.
As biotech zombies with failed programs and money in hand go, Galapagos NV is a notable example, with a number of misses in the clinic, $3.1 billion in the bank, and a market capitalization of $2.19 billion.
Cardiff Oncology Inc.’s mid-stage and ongoing clinical trial of its PLK1 inhibitor in colorectal cancer produced promising data but the company’s stock lost a quarter of its value on July 30 because of second-quarter losses. The randomized phase II study of onvansertib combined with a standard-of-care treatment in first-line, RAS-mutated metastatic colorectal cancer produced a 49% confirmed objective response rate at the 30-mg dose level compared to 30% in the control arm.
Madrigal Pharmaceuticals Inc.’s long-awaited business development pact became reality by way of an exclusive global license agreement that could be worth more than $2 billion with CSPC Pharmaceutical Group Ltd., of Shijiazhuang, China, for SYH-2086. The candidate is a preclinical oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist and orforglipron derivative.
The news that Vinay Prasad has stepped down as CBER director at the U.S. FDA had some biotech stocks literally jumping in joy as the market opened July 30. Meanwhile, Prasad’s decisions regarding vaccine development, as well as actions by Makary and HHS Secretary Robert Kennedy, are coming under fire.
At the 2025 Alzheimer’s Association International Conference (AAIC), one of the bigger splashes was made by a cardiovascular drug. In a presentation on July 30, Newamsterdam Pharma Co. NV presented data showing that its cholesterol drug obicetrapib lowered levels of the Alzheimer’s Disease biomarker p-tau217.
RSS
