Following a data-cleaning delay and mixed results in Alzheimer’s disease, Annovis Bio Inc. reported phase III Parkinson’s disease data showing treatment with buntanetap stops cognitive decline and improves motor and other functions, including postural instability and gait difficulty, meeting all primary and secondary endpoints. Read More
Cartesian Therapeutics Inc.’s phase IIb study of its lead candidate, Descartes-08, in treating generalized myasthenia gravis (gMG) hit its primary endpoint while the company also notched a $130 million private placement equity financing. Read More
Tracon Pharmaceuticals Inc. is shuttering all development of its subcutaneous PD-L1 antibody, envafolimab, after the pivotal trial failed to meet the primary endpoint in soft tissue sarcoma. Read More
The U.S. Department of Health and Human Services (HHS) and the FDA already are getting a glimpse of the post-Chevron world and how the Supreme Court’s June 28 unwinding of the 40-year-old Chevron deference could rein in agency policies that defy Congress’ expressed intent. Read More
The U.S. FDA approved three biosimilar products from Samsung Bioepis Co. Ltd., Tanvex Biopharma Inc. and Formycon AG as follow-on biologics to Stelara (ustekinumab), Neupogen (filgrastim) and Eylea (aflibercept), respectively, on June 28. Read More
China’s National Medical Products Administration authorized the country’s first cetuximab biosimilar with the approval of Simcere Zaiming’s Enlituo (CMAB-009, cetuximab beta injection) in combination with chemotherapy as first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer. The biosimilar references originator drug Erbitux (cetuximab, Eli Lilly and Co.). Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alvotech, Ardelyx, Cassava, Dormer, Kashiv, Verrica. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Formycon, Humacyte, Idorsia, Longboard, Mesoblast, Sandoz, Springworks, Syncromune, Taurx, Valneva. Read More
