OncologyRegulationApprovals May 16, 2025 FDA grants RMAT to BrainChild Bio’s CAR T-cell therapy for DIPG By PBR Staff Writer This marks a step forward in the development of treatments for this incurable paediatric brain tumour. BrainChild Bio noted that a CAR T-cell therapy overcomes the challenges posed
Drug Manufacturing May 15, 2025 AbbVie and ADARx to develop siRNA therapeutics for multiple disease areas By PBR Staff Writer Under the agreement terms, AbbVie will pay ADARx an upfront of $335m, and the latter is also said to be qualified for additional payments. These include option-related fees,
RegulationApprovalsDrug Manufacturing May 14, 2025 FDA to review Regenxbio’s gene therapy BLA for Hunter syndrome By PBR Staff Writer The agency has granted the application priority review, setting a Prescription Drug User Fee Act (PDUFA) target action date of 9 November 2025. The therapy has secured several
RegulationApprovalsDrug Manufacturing May 13, 2025 InnoCare’s Mesutoclax obtains breakthrough therapy designation in China By PBR Staff Writer This designation is intended for the treatment of BTKi-treated relapsed or refractory mantle cell lymphoma (R/R MCL). Mesutoclax becomes the inaugural BCL2 inhibitor to receive BTD recognition in
CardiovascularDrug Manufacturing May 12, 2025 Sirius secures $50m to advance siRNA therapeutics for cardiometabolic disorders By PBR Staff Writer The funds are also used in the enhancement of the company’s RNA delivery technologies. A corporate venture capital firm spearheaded the financing round, with participation from new investor
Drug ManufacturingCentral Nervous System May 9, 2025 MIRA secures board approval to buy SKNY Pharmaceuticals By PBR Staff Writer The strategic decision follows thorough independent valuations of both entities, with the merger contingent upon approval from shareholders of both companies. Moore Financial Consulting conducted a third-party analysis
Infectious DiseaseDrug Manufacturing May 8, 2025 Evotec secures $2.5m grant for TB treatment development By PBR Staff Writer It is said to be the second grant awarded by the foundation to the company and marks the continuation of a productive five-year collaboration between the parties. Evotec’s
RegulationDrug Manufacturing May 7, 2025 FDA grants fast track status to Alterity’s multiple system atrophy treatment By PBR Staff Writer The fast-track application included top-line data from the double-blind randomised Phase II clinical trial, which showed efficacy on the modified Unified Multiple System Atrophy Rating Scale (UMSARS)I alongside
Drug Manufacturing May 6, 2025 USPTO grants two additional patents to Moleculin’s drug candidate By PBR Staff Writer These patents have a base patent term extending until June 2040. This is contingent upon the alteration due to any delays in the prosecution process and extension to
Research & DevelopmentDrug Manufacturing May 5, 2025 PCI completes acquisition of sterile fill-finish CDMO Ajinomoto Althea By Gullapalli Prasanna Last month, PCI signed a deal to acquire Ajinomoto Althea, a subsidiary of Japan-based Ajinomoto. This acquisition is part of PCI’s investment strategy to enhance its manufacturing capabilities