With full approval from the U.S. FDA in hand for Travere Therapeutics Inc.’s Filspari (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression, eyes turned to future prospects as well as how a revised risk evaluation and mitigation strategies (REMS) program might shake out. During a conference call hosted by Travere, Leerink analyst Joseph Schwartz wanted to know what changes might be made, and if the regulator’s decision might “actually be an entire removal” of the REMS. Read More
Vor Biopharma Inc.’s trem-cel, a stem cell transplant designed to block the toxicity from cancer treatments, has produced some positive early stage results, including delayed relapse in patients. Phase I/IIa study data showed participants with relapsed/refractory acute myeloid leukemia benefited from trem-cel followed by treatment with Pfizer Inc.’s antibody-drug conjugate cancer fighter Mylotarg (gemtuzumab ozogamicin). Read More
Biopharma financing activity surged in the first eight months of 2024, reaching $77.5 billion, a 91.25% increase from the $40.52 billion raised during the same period in 2023. August saw a slight dip in funding, with $3.48 billion raised compared to $3.71 billion in July. Read More
In a deal that brings $60 million in cash and equity up front, plus up to $575 million in milestone payments, Shanghai-based Epimab Biotherapeutics Inc. and San Diego-based Vignette Bio Inc. entered a licensing agreement for Epimab’s BCMA-targeting T-cell engager, EMB-06, for autoimmune disease. Read More
Immortality and eternal youth have been the stuff of myths and legends from ancient times on. Now, in the 21st century, real studies of current medicine could be applied to repair tissues and organs damaged by age. During the 11th Aging Research & Drug Discovery (ARDD) Meeting held at the University of Copenhagen at the end of August, scientists explained the molecular keys of rejuvenation, as many artists imagined in the past. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Crestone, Cyclo, Eli Lilly, Indaptus, Pleopharma, Poseida. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Eli Lilly,ENA, Genetic Leap, Hoth, In8bio, Novartis, Voyager. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abdera, Advanz, Lisata, Moderna, Perspective, Simcere, Vivet. Read More
