All articles by Swagath Bandhakavi

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