BioPharm International - Latest News and Information
Earendil Labs announced a $787 million financing round, the largest recent capital raise for AI‑enabled drug development. The funding, led by Sanofi and the Biotech Development Fund, will be used to scale its AI‑driven biologics discovery platform, expand R&D teams, and push more than 40 antibody programs toward clinical trials, including Phase II candidate HXN‑1001. The company markets its platform as a continuous production engine that integrates computational modeling with experimental validation. Strategic collaborations with Sanofi broaden the reach into autoimmune and oncology indications.
Sun Pharmaceutical's tildrakizumab (Ilumya) received FDA acceptance for a supplemental biologics license application to treat active psoriatic arthritis. The sBLA is backed by two Phase III INSPIRE studies involving more than 800 patients, which met primary endpoints with significant ACR20 improvements...
Shilpa Biologicals and mAbTree Biologics received FDA orphan drug designation for an investigational monoclonal antibody that targets an immune‑evasion pathway in essential thrombocythemia and polycythemia vera. The designation validates the novel mechanism and accelerates plans for IND‑enabling studies and first‑in‑human...
Phase I trials have evolved from simple safety checks into data‑rich, adaptive studies that integrate biomarker strategies, exposure‑response analyses, and formulation optimization. Regulators now expect sponsors to justify Phase II dosing decisions, making early pharmacodynamic and target‑engagement data essential. Emerging biotechs face...
Propanc Biopharma announced that its proenzyme therapy PRP is moving toward a Phase Ib first‑in‑human study for advanced pancreatic cancer. The company highlighted preclinical data showing more than 85 % tumor‑growth inhibition and secured FDA orphan‑drug designation. A validated pharmacokinetic assay developed...
Biogen reported Phase Ib data for its antisense oligonucleotide salanersen, showing substantial neurofilament light chain reductions and new motor milestones in children with spinal muscular atrophy (SMA) who had previously received onasemnogene abeparvovec. The study of 24 participants demonstrated a roughly...
Johnson & Johnson has filed a Type II variation with the European Medicines Agency to add teclistamab, a bispecific T‑cell‑redirecting antibody, as a second‑line monotherapy for relapsed/refractory multiple myeloma. The Phase III MajesTEC‑9 trial, enrolling 614 patients, demonstrated a 71 % reduction in...
BioNTech announced it will create an independent biotech company dedicated to next‑generation mRNA technologies. The spin‑out will be led by co‑founders Ugur Sahin and Özlem Türeci, who will assume management by the end of 2026. BioNTech will contribute core mRNA assets in...
