All articles by Swagath Bandhakavi
Opus Genetics receives FDA RMAT designation for OPGx-LCA5
OPGx-LCA5 is undergoing early-stage clinical trials for treating Leber congenital amaurosis linked to mutations in the LCA5 gene
FDA approves Teva-Alvotech biosimilar Selarsdi for multiple conditions
The approval permits SELARSDI to be utilised for all its sanctioned indications, including adult and paediatric psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ulcerative colitis
Efti-KEYTRUDA combo achieves 17.6-month survival in Immutep’s TACTI-003 trial
The findings meet an essential need for first-line HNSCC patients with low PD-L1 expression, who make up about 20% of cases and have limited treatment options
Repare out-licenses oncology discovery platforms to DCx Biotherapeutics
The agreement covers intellectual property related to Repare’s SNIPRx, SNIPRx-surf, and STEP2 platforms, and involves the transfer of specific research assets and team members
X-Chem extends drug discovery collaboration with Orion Pharma
Orion will now use X-Chem’s integrated platform across various programmes to advance the identification and optimisation of small molecule drug candidates
FDA approves Abeona’s ZEVASKYN gene therapy for RDEB
ZEVASKYN is made from a patient’s own skin cells, genetically modified to produce Type VII collagen
EC approves Regeneron’s Lynozyfic for advanced multiple myeloma
Lynozyfic acts as a bispecific antibody, focusing on the B-cell maturation antigen in myeloma cells and activating CD3-expressing T cells to fight cancer
Johnson & Johnson’s TREMFYA gains EC approval for ulcerative colitis
The regulatory approval targets patients who have insufficiently responded to or are unable to tolerate conventional or biologic treatments
AbbVie seeks FDA approval for TrenibotE to treat glabellar lines
AbbVie is positioning TrenibotE, a serotype E botulinum neurotoxin, as an option for patients exploring aesthetic neurotoxin treatments for the first time
Veraxa Biotech to go public via $1.64bn SPAC deal with Voyager Acquisition
The company is advancing antibody-based therapies using its proprietary BiTAC platform, which enables dual-marker targeting to enhance precision in solid tumour treatment