Takeda Pharmaceutical Company announced positive results from its Phase 2b clinical trial for TAK-279, an investigational oral TYK2 inhibitor for treating psoriatic arthritis. Meeting its primary endpoint, the study confirmed that TAK-279 improved symptoms significantly better than a placebo at 12 weeks. This news supports TAK-279’s potential as a robust oral treatment for psoriatic arthritis […]
Dong-A ST, the South Korean pharmaceutical company, has received confirmation from the European Medicine Agency (EMA) of the acceptance of their Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara (ustekinumab). The MAA was submitted to the EMA by Accord, a subsidiary of Intas Pharmaceuticals, on June 23rd, and the agency accepted the submission […]
Lupin Limited has secured approval from Health Canada for Rymti, the company’s biosimilar to Enbrel (etanercept), an inhibitor of tumour necrosis factor (TNF). Rymti is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, plaque psoriasis, and paediatric plaque psoriasis. Lupin said that Rymti is available in Canada as an […]
Chinese biopharma company Bio-Thera Solutions has signed a commercialization and license deal worth up to $150 million with Hikma Pharmaceuticals to commercialize the former’s BAT2206. BAT2206 is a monoclonal antibody, which is being developed by the UK-based pharma company as a biosimilar referencing Jansen’s Stelara (ustekinumab), in the US. Stelara is presently approved for the […]
Johnson & Johnson’s Janssen Pharmaceutical said that its IL-23 p19 inhibitor TREMFYA (guselkumab) met the primary endpoints of American College of Rheumatology 20% improvement (ACR20) in two phase 3 trials in adults with active psoriatic arthritis. Safety profiles observed for guselkumab in the two trials – DISCOVER 1 and 2 were in line with its […]
Amgen Inc. has officially submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to Johnson & Johnson’s REMICADE (infliximab). This submission marks a significant milestone in Amgen’s efforts to expand its biosimilar portfolio. ABP 710: A Biosimilar to Infliximab ABP 710 is being developed […]
The European Commission (EC) has granted Novartis approval for a significant update to the label of its psoriatic arthritis treatment, Cosentyx (secukinumab). This update introduces new dosing flexibility, allowing for administration of up to 300mg based on individual clinical response. This development provides clinicians with enhanced options to tailor treatments for their patients suffering from […]