RegulationApprovalsRespiratory March 10, 2025 UK MHRA approves Vertex’s Alyftrek for cystic fibrosis By PBR Staff Writer The approval is intended for those who have a minimum of one F508del mutation or another responsive CFTR gene mutation. The company is working with the National Institute for Health and
Drug Manufacturing March 7, 2025 Relief and Renexxion terminate merger talks By PBR Staff Writer Despite a non-binding letter of intent signed in November last year, the companies have mutually decided to discontinue negotiations after failing to meet critical conditions within the set
Drug Manufacturing March 6, 2025 CordenPharma announces $1bn investment in peptide development and production By PBR Staff Writer This investment is part of the company’s plan to broaden its Peptide Platform business and exceed €1bn in sales by 2028. CordenPharma has finalised plans for a new
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