Capricor Therapeutics Inc. received a complete response letter (CRL) from the U.S. FDA on the BLA for deramiocel to treat cardiomyopathy in Duchenne muscular dystrophy patients. The company’s CEO said the letter was unexpected. Read More
Roche AG subsidiary Chugai Pharmaceutical Co. Ltd. and Singapore’s Gero Pte. Ltd. plan to tackle age-related diseases by collaborating to identify drug targets through Gero’s AI-driven human data-first platform. Read More
The National Institutes of Health has opened another front in its cost cutting drive, saying it will cap the fees science journals charge for publishing papers authored by researchers it funds. Read More
Biopharma dealmaking in June 2025 reached $35.07 billion, the highest monthly total of the year so far and one of the strongest single-month performances in recent years. The June surge helped push first-half 2025 deal value to $138.31 billion, outpacing the first half of 2024 and exceeding full-year totals from several pre-2020 years. Read More
Shanghai Circode Biomed Co. Ltd. is set to begin clinical trials of HM-2002, a circular RNA (circRNA)-based drug for ischemic heart disease, having gained IND clearance in China Jan. 10 and the U.S. on May 30, Circode CEO Chenxiang Tang recently told BioWorld. Read More
At first blush, the brain’s extracellular matrix (ECM) seems like the opposite of synaptic plasticity. Plasticity is the ability to change; the ECM is stable, to the point that it is often described as a scaffold – something to lend stability. “ECM proteins have some of the longest lifetimes of any protein in the brain,” Anna Molofsky told her audience at the XVII Meeting on Glial Cells in Health and Disease, which is being held in Marseille this week. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astellas, Mereo, Osivax, PDS, Pfizer, Tonix, Ultragenyx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Beone, Biocytogen, Eolas, Secarna, Vect-Horus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcus, Ascentage, Beigene, Klotho, Merck, Moderna, Taiho, Transcend. Read More