ApprovalsResearch & Development October 6, 2025 FDA fast-tracks Alto Neuroscience’s ALTO-101 for CIAS treatment By PBR Staff Writer Currently, there are no approved treatments for CIAS, a key feature of the condition that significantly affects daily functioning and the quality of life for individuals living with
Oncology September 23, 2025 Avenzo Therapeutics secures $60m in series B funding for oncology therapies By PBR Staff Writer The total capital raised by the company now stands at $446m, following a $386m series A/A-1 financing announced in November 2024. The series B round was led by
ImmunologyInflammation September 11, 2025 Odyssey Therapeutics raises $213m via Series D By PBR Staff Writer The Boston-based company secured backing from existing investors and new investors, including Affinity Asset Advisors, Dimension Capital, Jeito Capital, Lightspeed Ventures, TPG Life Sciences Innovations, and Wedbush Healthcare
Neurology September 4, 2025 Andelyn and Tern partner for gene therapy to treat CLN2 Batten disease By PBR Staff Writer This therapy is aimed at addressing vision loss in children with this disease, a rare paediatric neurodegenerative disorder for which there is currently no treatment available for its
Approvals August 29, 2025 EMA grants orphan designation to Aldeyra’s ADX-2191 for vitreoretinal lymphoma By PBR Staff Writer This is a rare and aggressive form of cancer for which there is no approved treatment currently. Aldeyra president and CEO Todd Brady said: “Primary vitreoretinal lymphoma is
Neurology August 20, 2025 Santhera signs deal with Uniphar for GCC distribution of Agamree By PBR Staff Writer The therapy is intended for the treatment of Duchenne muscular dystrophy (DMD) in patients aged four years and above. Sales are projected to begin on a named patient
Oncology June 30, 2025 Mabwell signs Albipagrastim alfa deal with Qilu Pharmaceutical By PBR Staff Writer This agreement grants Qilu exclusive rights to develop, manufacture, enhance, utilise and commercialise Albipagrastim alfa for Injection in Greater China including Chinese Mainland, Macau, Hong Kong and Taiwan.
Oncology June 26, 2025 FDA approves Plus Therapeutics’ Reyobiq for paediatric brain cancer By PBR Staff Writer Paediatric HGG, including ependymoma, are not only rare but also very difficult to treat, with current standard care failing to prevent recurrence and with five-year survival rates. Reyobiq
Drug ManufacturingRegulationGastrointestinal June 19, 2025 Johnson & Johnson submits sBLA to FDA to extend use of ustekinumab By PBR Staff Writer The application is underpinned by the multi-centre, open-label Phase III UNITI-Jr clinical trial data, which assessed the therapy’s safety, pharmacokinetics, and efficacy in paediatric subjects. At present, Stelara
Drug Manufacturing May 26, 2025 Orion partners with Shilpa Biocare for recombinant human albumin in Europe By PBR Staff Writer This key plasma protein of Shilpa is utilised across different medical applications. It is developed using a non-human expression system that ensures scalability, high safety and virus-free production.