All articles by Swagath Bandhakavi
FDA grants approval for Genentech’s Susvimo in diabetic retinopathy
Susvimo’s ranibizumab formulation works by inhibiting VEGF-A, a protein linked to the formation and permeability of blood vessels
Lilly’s Kisunla secures approval in Australia for treatment of early Alzheimer’s
Kisunla is a four-weekly intravenous therapy designed for adults with mild cognitive impairment or mild dementia caused by Alzheimer’s disease
FDA introduces stricter guidelines for COVID-19 vaccine makers
The updated framework moves away from the “one-size-fits-all” policy, implementing stricter approval criteria specifically for vaccines targeting individuals under 65 who do not have risk factors
GSK’s Blenrep gains approval in Japan for advanced multiple myeloma
The approval is based on the findings of the DREAMM-7 and DREAMM-8 trials, which assessed Blenrep with BVd and BPd in patients previously treated at least once
GSK to acquire liver disease drug candidate efimosfermin in deal worth up to $2bn
Efimosfermin is currently undergoing Phase III clinical trials for the treatment of metabolic dysfunction-associated steatohepatitis and alcohol-related liver disease
Azafaros raises €132m to advance Phase 3 trials for lysosomal disorder treatments
The funding will accelerate the development of Azafaros’ main compound, nizubaglustat, with Phase 3 trials for Niemann-Pick disease Type C and GM1/GM2 gangliosidoses expected to begin by year’s end
InnoCare’s Mesutoclax gains breakthrough status in China for lymphoma treatment
This designation applies to treating mantle cell lymphoma in patients who have experienced relapse or resistance following Bruton tyrosine kinase inhibitor therapy
LENZ Therapeutics and Lotus partner for LNZ100 distribution in Asia
Under the agreement, LENZ Therapeutics will earn up to $125m through initial fees and milestone payments, in addition to receiving tiered royalties from net sales
Amneal and Apiject join forces to boost US pharmaceutical manufacturing
The partnership will target the expansion of Apiject’s blow-fill-seal injectable platform at Amneal’s Brookhaven facility in New York
Viralgen and Trogenix collaborate on GMP-ready AAV therapy for glioblastoma
The partnership focuses on progressing TGX-007, an investigational gene therapy being developed for the treatment of glioblastoma