Tags : Autoimmune Diseases

Innovent’s Sulinno (biosimilar, adalimumab) Receives NMPA’s Approval for Autoimmune Diseases

Shots: The NMPA has approved Sulinno for the treatment of RA, AS, and psoriasis in China. The approval of the Sulinno marks the expansion of Innovent’s portfolio in the non-oncology field Sulinno has similar clinical efficacy and safety to its reference product, Humira. The launch will provide Chinese patients with affordable adalimumab, bringing hope and […]Read More

AbbVie Signs an Exclusive Research and Option to License Agreement

Shots: Sosei to receive ~$32M as upfront and ~$377M as option fees, development, and commercial milestones along with royalties on global sales of therapies. AbbVie to get an option to expand the collaboration up to a total of four therapies that modulate GPCR Sosei will leverage its StaR technology and GPCR-focused SBDD capabilities and fund […]Read More

Pfizer’s Ruxience (biosimilar, rituximab) Receives CHMP’s Positive Opinion for Cancer

Shots: The EMA’s CHMP has adopted a positive opinion, recommending MAA for Ruxience, a biosimilar referencing MabThera The regulatory submission is based on REFLECTIONS B3281006 study assessing the efficacy, safety, immunogenicity, PK/PD of Ruxience demonstrating biosimilarity to the reference product in patients with CD20+, low tumor burden FL Ruxience is a mAb indicated for the […]Read More

Celgene Amends its Existing Collaboration with Editas to Develop and

Shots: Editas to receive $70M up front, milestone and royalty payments for each therapy developed by Celgene and will develop genome editing tool for which Celgene has right to opt-in to such genome editing tools for the development of gene-edited alpha-beta T cell therapies In May’2015, Editas and Juno entered into an exclusive collaboration to […]Read More

Astellas Signs an Exclusive License Agreement with Pandion to Deliver

Shots: Pandion to receive up to $45M as upfront and payments for research and preclinical activities, ~$750M as development and commercial milestone and royalties on global sales of the therapies developed via collaboration Pandion to be responsible for drug designing and discovery of bispecific therapies utilizing its modular immune effector and tissue tether platform while […]Read More

Samsung Bioepis’ Hadlima (biosimilar, adalimumab) Receives FDA’s Approval for Autoimmune

Shots: The FDA’s approval is based on P-III clinical study assessing Hadlima vs reference product, Humira (adalimumab) in 544 patients in a ratio (1:1) with moderate to severe rheumatoid arthritis despite methotrexate therapy The P-III clinical study resulted in biosimilarity data of Hadlima to the reference product Humira, i.e, @24 wks. ACR20 (72.4% vs 72.2%). […]Read More

Pfizer’s Ruxience (biosimilar, rituximab) Receives FDA’s Approval for Cancer and

Shots: The approval is based on REFLECTIONS B3281006 study results assessing Ruxience vs reference product, Rituxan (rituximab) in patients with CD20-positive, low tumor burden follicular lymphoma The REFLECTIONS B3281006 study results demonstrated biosimilarity data of Ruxience to the reference product. Ruxience is the third biosimilar of Pfizer’s oncology portfolio to be approved in the US […]Read More

Roche Signs a Worldwide License Agreement with Parvus Therapeutics to

Shots: Parvus to receive an upfront & milestones exceeding $800M and royalties on sales of products targeting for IBD, ALD & Celiac diseases, and will conduct pre/clinical studies till P-I study. Additionally, will also obtain milestones & royalties on sales of products for other therapy areas Roche to get WW license to develop and commercialize […]Read More