Regulation December 19, 2025 MHRA launches call for evidence on AI regulation in UK healthcare sector By Salong Debbarma The initiative aims to shape future standards and safeguards for the way AI is used in healthcare settings. This call for evidence will inform the work of the
Drug Manufacturing December 18, 2025 EC approves Incyte’s Minjuvi combo for follicular lymphoma By PBR Staff Writer FL is the most common slow-growing B-cell non-Hodgkin lymphoma form. Minjuvi is a humanised, fragment crystallisable-modified cytolytic monoclonal antibody targeting cluster of differentiation 19. The EC approval follows
Drug Discovery December 17, 2025 Harbour BioMed and BMS sign multi-specific antibody collab By PBR Staff Writer Harbour BioMed will work alongside BMS to progress and expedite the programmes aimed at the discovery of the antibodies. Harbour BioMed, in exchange, is eligible to obtain payments
Drug Discovery December 16, 2025 LEO Pharma applies to EMA to expand Anzupgo use to adolescents By PBR Staff Writer The expansion is targeted at individuals for whom topical corticosteroids are not sufficient or appropriate. The European regulator has accepted the application for review. The submission is based
Drug Discovery December 15, 2025 FDA approves Acadia’s Daybue Stix for Rett syndrome By PBR Staff Writer Rett syndrome is a rare neurodevelopmental disorder that progresses through four stages. The formulation is intended to treat the condition in adult and paediatric patients aged two years
Drug Discovery December 12, 2025 Formation Bio gains global rights to Lynk Pharma’s TYK2 inhibitor By PBR Staff Writer This next-generation central nervous system (CNS)-penetrant will be developed by Bleecker Bio, a newly established subsidiary of Formation. Lynk Pharmaceuticals will obtain a minority equity stake in Bleecker,
Drug Manufacturing December 12, 2025 Zealand Pharma and OTR to develop metabolic disease therapeutics By PBR Staff Writer The multi-programme partnership leverages Zealand Pharma’s experience in obesity and metabolic health alongside OTR Therapeutics’ research and development (R&D) platform to address the needs of people with metabolic
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