Tags : Rheumatoid Arthritis

Biosimilars

Biogen Signs a License and Commercialization Agreement with Bio-Thera for

Shots: Bio-Thera to receive $30M up front following the achievement of P-III satisfactory results and is eligible for commercial milestones along with royalties. The transaction is expected to close in Q2’21 Biogen to get exclusive regulatory, manufacturing, and commercial rights of BAT1806 in all countries excluding China (includes Hong Kong, Macau, and Taiwan) Biogen will […]Read More

Pharma

Pfizer Signs a License and Research Agreement with Imcyse to

Shots: Imcyse to receive up front, ~$180M as milestones along with royalties. Pfizer to purchase an equity stake in Imcyse Initially, the companies will collaborate to develop existing lead candidates and further optimize potential molecules. Later, Pfizer will lead clinical development and commercialization activities for the program The Imotope platform is a curative approach to […]Read More

Regulatory

Gilead’s Jyseleca (filgotinib) Receives the MHLW’s Approval for Rheumatoid Arthritis

Shots: The approval is based on two clinical trials (P-III FINCH and P-II DARWIN) programs assessing Jyseleca in 3,500+ patients across a range of RA patient populations, including patients new to treatment and those who have demonstrated inadequate response to treatment with SOC including biologic DMARDs. Gilead and Eisai will jointly commercialize Jyseleca across Japan […]Read More

Pharma Regulatory

Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion

Shots: The CHMP’s positive opinion is based on P-III FINCH and P-II DARWIN programs that included 4,544 RA patient-years of experience with filgotinib. All three FINCH trials involve a broad range of patients that met their 1EPs  In the trials, the drug achieved ACR20/50/70 and DAS28(CRP)<2.6. Moreover, Filgotinib inhibited the progression of structural joint damage […]Read More