All articles by Swagath Bandhakavi
Swagath Bandhakavi
EC grants conditional approval for Italfarmaco’s Duvyzat in DMD treatment
The approval applies to patients irrespective of the genetic mutation involved, provided Duvyzat is given alongside corticosteroids
Alvotech and Dr. Reddy’s to co-develop biosimilar to Keytruda
The biosimilar candidate aims to leverage the combined expertise of Alvotech and Dr. Reddy’s Laboratories to improve accessibility to this crucial medication
Acerand Therapeutics begins Phase 1 trial of ACE-232 in mCRPC
The Phase I trial is conducted in the US and China, comprising a dose-escalation stage (Phase IA) and a dose-optimisation stage (Phase IB)
FDA approves Bayer’s Nubeqa for advanced prostate cancer treatment
The approval has been driven by findings from the ARANOTE trial, which demonstrated a 46% reduction in the risk of radiological progression or death when darolutamide was combined with ADT, compared to a placebo with ADT
Regeneron signs licensing deal worth up to $2bn for Hansoh’s obesity drug candidate
Through the deal, Regeneron Pharmaceuticals secures exclusive rights to develop and market a dual GLP-1/GIP receptor agonist beyond Mainland China, Hong Kong, and Macau
Daiichi Sankyo and Merck withdraw BLA for patritumab deruxtecan in US
The decision comes after examining overall survival results from the HERTHENA-Lung02 Phase 3 trial, which failed to achieve statistical significance, in conjunction with talks with the FDA
Regeneron partners with Telesis Bio for swift on-site gene synthesis
The Gibson SOLA platform is a reagent-based system equipped with software tools designed for integration across multiple scales and throughput capacities
Teva and Biolojic launch IND studies for BD9 in atopic dermatitis and asthma
BD9 seeks to improve treatment outcomes for atopic dermatitis and asthma by targeting and inhibiting two main drivers of TH2-driven inflammation, addressing gaps in current therapies
FDA grants priority review to Otsuka’s IgAN candidate sibeprenlimab
Sibeprenlimab, administered through subcutaneous injection, targets the APRIL protein associated with the development of IgAN, enabling patients to self-administer the treatment
FUJIFILM Diosynth secures $3bn manufacturing deal with Regeneron
FUJIFILM Diosynth will deliver manufacturing services from its upcoming biopharmaceutical facility in Holly Springs, North Carolina