Approvals December 9, 2025 EC approves Roche’s Gazyva to treat active lupus nephritis By Salong Debbarma Lupus nephritis classifications indicate the severity and type of kidney damage, which is central to the disease. The EC’s decision is based on outcomes from the Phase II
Production & Sales December 4, 2025 Formosa and Rxilient sign licensing agreement for APP13007 By Salong Debbarma The licensing agreement covers Thailand, Singapore, the Philippines and Indonesia, granting Rxilient rights to market APP13007, a patented medicine for treating inflammation and pain after ocular surgery. It
Research & Development December 3, 2025 AGC Biologics to expand cell line development with ATUM partnership By Salong Debbarma With this collaboration, drug developers get access to the technology, which is designed to increase yields and reduce the time required to reach clinical trials. The ATUM’s transposase-based
Research & Development December 2, 2025 Solid Biosciences’ SGT-212 gains FDA rare paediatric disease status By Salong Debbarma The designation, which covers serious and life-threatening diseases affecting those under 18, may allow the company a paediatric priority review voucher for future regulatory submissions. SGT-212 is designed
Approvals December 1, 2025 Eisai seeks PMDA approval for subcutaneous Leqembi in Japan By PBR Staff Writer The formulation will serve as a new administration route. Eisai’s application is based on data from several SC administration sub-studies of lecanemab, conducted within the Phase III Clarity
Drug Manufacturing November 25, 2025 Made Scientific and Cellergy partner to advance CLG-001 By PBR Staff Writer Cellergy will utilise the good manufacturing practices (GMP) expertise of Made Scientific to enhance its mitochondrial isolation and purification process for the clinical-grade production of CLG-001. This work
Research & Development November 24, 2025 AstraZeneca to expand biomanufacturing in Maryland, US By PBR Staff Writer The investment covers both expansion of the Frederick biologics manufacturing facility and a new plant construction in Gaithersburg, targeting operational readiness by 2029. The Frederick site, which produces
Research & Development November 21, 2025 Aspen closes $115m in Series C to advance Parkinson’s cell therapy By PBR Staff Writer This round will also bolster the company’s manufacturing offerings and support additional pipeline therapies. It was jointly led by OrbiMed, Frazier Life Sciences, ARCH Venture Partners and Revelation
Approvals November 19, 2025 USPTO grants patent to Genprex’s Reqorsa gene therapy By PBR Staff Writer The protection for this patent will last until 2037. Genprex has also obtained similar patent protection for the gene therapy used with PD-L1 antibodies in Korea, and is
Neurology November 14, 2025 Eisai and Biogen report Leqembi’s MHRA approval for Alzheimer’s By PBR Staff Writer Leqembi is a humanised anti-soluble aggregated amyloid-beta monoclonal antibody. The development follows the August 2024 approval for treating mild cognitive impairment (MCI) and mild dementia caused by Alzheimer’s