RegulationApprovalsDrug Manufacturing November 3, 2025 Calluna secures FDA orphan drug designation for CAL101 in IPF By PBR Staff Writer CAL101 is intended for the treatment of idiopathic pulmonary fibrosis (IPF). It is currently studied in the Phase II AURORA trial, with patient recruitment underway in the US,
Production & Sales October 31, 2025 Arcutis introduces roflumilast cream for paediatric atopic dermatitis By PBR Staff Writer This topical, steroid-free formulation is applied once daily and can be used for long-term disease control without limits on duration or body surface area. Clinical trials have shown
Production & SalesRegulation October 30, 2025 Samsung Bioepis to acquire commercial rights for Byooviz in Europe By PBR Staff Writer The agreement covers Samsung Bioepis’ two ophthalmology assets, Byooviz (ranibizumab) and Opuviz (aflibercept), in Europe. The transfer returns commercial rights for Byooviz to Samsung Bioepis and positions the
Drug DiscoveryOncology October 29, 2025 Myrio Therapeutics announces partnership for immunotherapy development By PBR Staff Writer This tripartite agreement leverages expertise in cell immunotherapies, peptide HLA (pHLA) binder discovery, and bispecific T cell engagers, with the aim of overcoming challenges to achieving durable cancer
Research and Development (RD)Production & Sales October 28, 2025 Hovione finalises $100m investment for East Windsor site expansion in US By PBR Staff Writer Following expansion, the site will cover over 200,000ft² and feature new technologies in sustainably designed facilities. The initial phase of expansion comprises a 31,000ft² building that will accommodate
Approvals October 27, 2025 Biogen acquires global rights to Vanqua C5aR1 antagonist By PBR Staff Writer The deal advances Biogen’s immunology strategy, focussing on established immune mechanisms that may address inflammatory disorders with considerable unmet need. Biogen’s early-stage immunology pipeline is bolstered by the
Research & Development October 24, 2025 Naobios and TMIMS to develop new live mpox vaccine By PBR Staff Writer The focus of this partnership is to create a new vaccine utilising a non-replicating highly attenuated vaccinia virus, designed to enhance safety and reduce the risk of emergence
Approvals October 23, 2025 Boehringer’s Jascayd gains NMPA approval for idiopathic pulmonary fibrosis By PBR Staff Writer This comes just two weeks after its US Food and Drug Administration (FDA) approval. The approval is based on results from FIBRONEER-IPF, a Phase III trial in IPF
Approvals October 22, 2025 Portal Therapeutics receives FDA orphan, fast track designations for PORT-77 By PBR Staff Writer In preclinical and Phase I studies in healthy participants, PORT-77 demonstrated a substantial reduction of plasma protoporphyrin IX (PPIX) through rapid ABCG2 inhibition. This outcome has the potential
OncologyProduction & Sales October 21, 2025 Citius Oncology finalises McKesson deal for Lymphir distribution By PBR Staff Writer Under this agreement, McKesson will act as an authorised distributor for the immunotherapy that has received approval from the US Food and Drug Administration (FDA) to treat adults