Drug Manufacturing January 17, 2025 Micron Biomedical secures funds for needle-free vaccine development By PBR Staff Writer This funding round was led by J2 Ventures and the Global Health Investment Corporation (GHIC). With this funding, the company’s total Series A equity value raised to over
ApprovalsRegulationOncology January 16, 2025 FDA clears Axcynsis’ AT03-65 IND for CLDN6-positive solid tumours By PBR Staff Writer The company is set to launch a multicentre Phase I trial in the US in the first quarter of this year. Axcynsis Therapeutics CEO Dr Zou Bin said:
Drug ManufacturingCentral Nervous System January 15, 2025 Cycle expands MS treatment portfolio with Banner Life Sciences acquisition By PBR Staff Writer BAFIERTAM will join TASCENSO ODT (fingolimod), Cycle’s other branded MS treatment. Both these therapies will be supported by Cycle’s hub programme, Cycle Vita. The company noted that, during
ApprovalsRegulationOncology January 13, 2025 JW Therapeutics’ Carteyva receives breakthrough therapy status for r/r LBCL By PBR Staff Writer This designation is for Carteyva, an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy, as a second-line treatment for adults with this disease. It is developed independently
Drug Manufacturing January 10, 2025 RheumaGen secures $15m in Series A funding to advance RA therapies By PBR Staff Writer SPRIM Global Investments and William Taylor Nominees jointly led the funding round, which will support the conduct of a Phase I trial of RheumaGen’s lead candidate, RG0401. Anticipated
Drug DiscoveryResearch & Development January 9, 2025 Parvus and Resilience expand partnership to develop IBD drug candidate By PBR Staff Writer PVT401 is said to be the second autoimmune drug candidate from Parvus. Parvus is focused on developing peptide-major histocompatibility complex (pMHC) nanomedicine drugs. These assets can activate in
ApprovalsOncologyRespiratory January 8, 2025 FDA grants priority review to Dizal’s sunvozertinib NDA for NSCLC treatment By PBR Staff Writer The decision is intended for individuals with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as assessed by an FDA-approved test. This marks offering a new
ApprovalsRegulationDrug Manufacturing January 7, 2025 Star Therapeutics’ von Willebrand disease therapy gains FDA fast track status By PBR Staff Writer The ‘fully human’, immunoglobulin G4 (IgG4) antibody is tailored to target Protein S, aiming to restore balance in blood clotting and potentially serves as a ‘universal haemostatic therapy’
ApprovalsOncologyGastric Cancer January 6, 2025 China’s NMPA approves Astellas’ advanced gastric cancer combo therapy By PBR Staff Writer This marks the first NMPA-approved monoclonal antibody that targets gastric tumour cells expressing the biomarker CLDN18.2. The approval offers a new, highly targeted treatment option for individuals particularly
ApprovalsOncologyRespiratory January 3, 2025 China’s NMPA approves Innovent’s taletrectinib for NSCLC treatment By PBR Staff Writer This decision follows the positive outcomes from the multicentre, open-label Phase II TRUST-I trial. The single-arm trial was instrumental in assessing the therapy’s tolerability, efficiency, and safety in