Rheumatoid Arthritis

Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis

July 24, 2020July 24, 2020Tuba Khan

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. [Read More...]

Lilly Reveals New Data for Olumiant (baricitinib) to Treat Rheumatoid Arthritis and Systemic Lupus Erythematosus #EULAR

June 3, 2020June 5, 2020Tuba Khan

Shots: Lilly to present results from a long-term study that evaluated the efficacy of Olumiant (4mg, qd) in patients with mod. to sev. [Read More...]

Gedeon Richter Launches Terrosa (biosimilar, teriparatide) in Europe

Gedeon Richter Signs an Asset Purchase Agreement with Mycenax for Biosimilar Tocilizumab to Treat Rheumatoid Arthritis

April 29, 2020May 7, 2020Shiwani Sharma

Shots: Mycenax to get $5M upfront and will get $16.5M as total deal value in four installments. Richter to get exclusive WW rights [Read More...]

Celltrion’s Remsima SC (biosimilar, infliximab) Receives KFDA’s Approval for Rheumatoid Arthritis

February 28, 2020February 28, 2020Tuba Khan

Shots: The KFDA has approved Celltrion’s Remsima SC for RA while the company is planning to seek approval for IBD within the year [Read More...]

AbbVie’s Rinvoq (upadacitinib) Receives ANVISA’s Approval for Rheumatoid Arthritis

February 5, 2020February 5, 2020Tuba Khan

Shots: The approval is based on five P-III studies of SELECT program, assessing Rinvoq in ~4,400 patients, including in Brazil The studies resulted [Read More...]

Gilead Signs an Exclusive Worldwide License Agreement with Novartis for its Three Preclinical Antiviral Programs

Gilead Reports Submission of Filgotinib’s NDA Under Priority Review to the US FDA for Rheumatoid Arthritis Treatment

December 20, 2019December 20, 2019Shiwani Sharma

Shots: The filling of NDA is based on P-III FINCH clinical program assessing Filgotinib in 3,452 patients with moderate to severely active RA [Read More...]

Cumberland Pharmaceuticals Receives FDA Approval for RediTrex Product Line

Cumberland Pharmaceuticals’ RediTrex (methotrexate) Injection Receives the US FDA’s Approval for Rheumatoid Arthritis and Psoriasis

December 13, 2019December 13, 2019Shiwani Sharma

Shots: The approval of RediTrex is done post no. of communications with the FDA and several amendments to the NDA submitted to the [Read More...]