Drug Manufacturing March 12, 2025 Aprea and MD Anderson sign agreement for APR-1051 By PBR Staff Writer The collaboration aims to explore this WEE1 kinase inhibitor for treating human papillomavirus + (HPV+) and HPV- HNSCC with specific genomic markers. As per the agreement, Aprea will
Metabolic DisordersRegulationMarketing Authorisation March 11, 2025 Vivus’ Qsymia gains market approval in UAE for obesity treatment By PBR Staff Writer This approval marks the first availability of the therapy in this region. The partnership between Vivus and its marketing partner PharmaAccess aims to equip healthcare providers in the
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