Drug Manufacturing March 5, 2025 FairJourney acquires Charles River’s San Francisco site By PBR Staff Writer The move is said to propel the company’s antibody discovery and engineering offerings, and is in line with its current growth plan. Previously known as Distributed Bio, the
ApprovalsRegulationDrug Manufacturing March 4, 2025 FDA approves Celltrion’s biosimilars for various indications By PBR Staff Writer This approval covers all indications of the reference products and the biosimilars are anticipated to be available by June 2025 in the country as per the settlement agreement
RegulationMarketing AuthorisationDrug Manufacturing March 3, 2025 EMA’s CHMP recommends marketing authorisation for Novartis’ Fabhalta By PBR Staff Writer The oral Factor B inhibitor of the alternative complement pathway is designed for this rare kidney condition with no approved treatments, which significantly impacts young individuals’ lives. The
Drug ManufacturingRegulationApprovals February 28, 2025 FDA grants fast track status for Avobis’ AVB-114 By PBR Staff Writer The designation is designed to accelerate the development and review of medications that show potential to address serious conditions. Candidates with this designation may qualify for an interaction
Drug Manufacturing February 27, 2025 China’s NMPA approves Fosun’s NDA of Tenapanor Hydrochloride tablets By PBR Staff Writer Carrying the Chinese trade name of Wan Ti Le, the tablets are indicated for individuals who have either insufficient response or cannot tolerate phosphorus binders. They are claimed
Marketing AuthorisationRegulationDrug Manufacturing February 26, 2025 Health Canada grants marketing authorisation to Kashiv’s Pegfilgrastim By PBR Staff Writer The decision paves the way for the commercial launch of the injection in the Canadian market. It supports the company’s aim to broaden biosimilar accessibility in the worldwide
Drug Manufacturing February 25, 2025 Biocon Biologics launches ustekinumab biosimilar in US By PBR Staff Writer Yesintek is claimed to be one of the first Stelara (ustekinumab) biosimilar market entrants in the US. The therapy gained approval for treating various conditions which includes Crohn’s
Drug Manufacturing February 24, 2025 Tiziana partners with Renaissance for intranasal foralumab production By PBR Staff Writer A fully human anti-cluster of differentiation (CD3) monoclonal antibody, intranasal foralumab is tailored to modulate the immune system and reduce neuroinflammation, which is a significant factor in the
Drug ManufacturingOncology February 21, 2025 Genmab’s epcoritamab gains approval in Japan for lymphoma treatment By PBR Staff Writer This marks Epkinly as the first subcutaneously administered T-cell engaging bispecific antibody approved in the country for R/R follicular lymphoma as well as R/R large B-cell lymphomas. The
Drug Manufacturing February 20, 2025 Nona Biosciences partners with UAB to advance B Cell research By PBR Staff Writer As part of the agreement terms, UAB has received a non-exclusive licence to leverage the H2L2 Harbour Mice platform of Nona Biosciences for the creation of fully human