Takeda’s TAK-279 meets primary endpoint in Phase 2b trial for psoriatic arthritis

Takeda’s TAK-279 meets primary endpoint in Phase 2b trial for psoriatic arthritis

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 […]

EMA accepts MAA for Dong-A ST’s Stelara biosimilar, DMB-3115

EMA accepts MAA for Dong-A ST’s Stelara biosimilar, DMB-3115

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 secures Health Canada approval for Enbrel biosimilar – Rymti

Lupin secures Health Canada approval for Enbrel biosimilar – Rymti

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 […]

Bio-Thera, Hikma Pharmaceuticals sign $150m licensing deal for BAT2206

Bio-Thera, Hikma Pharmaceuticals sign $150m licensing deal for BAT2206

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 […]

Amgen submits BLA for Infliximab biosimilar ABP 710 to FDA

Amgen submits BLA for Infliximab biosimilar ABP 710 to FDA

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 […]

EC approves dosing flexibility for Novartis’s Cosentyx in psoriatic arthritis treatment

EC approves dosing flexibility for Novartis’s Cosentyx in psoriatic arthritis treatment

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 […]