Gilead Sciences is building up its autoimmune disease drug pipeline by turning to EVOQ Therapeutics, a startup with technology that takes a novel approach to restoring immune tolerance. For EVOQ, the Gilead deal is its second with a big pharma company.
GSK drug otilimab failed a Phase 3 test in rheumatoid arthritis. Though the antibody drug met the main goal in two other pivotal studies, GSK said the limited efficacy in the third study means the company will not seek regulatory approval.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Galvani Bioelectronics, a joint venture between Verily and GSK, recently announced the first successful implantation of a neurostimulator that uses splenic nerve stimulation as an experimental therapy for rheumatoid arthritis patients.
The Study to Accelerate Information of Molecular Signatures (AIMS) found RA patients whose treatment was guided by the PrismRA blood test had three times better clinical responses compared to patients that didn't.
The European Commission and Japan's Ministry of Health, Labor and Welfare approved filgotinib, marketed under the name Jyseleca, for rheumatoid arthritis. The drug is partnered in Japan with Eisai. The FDA rejected the drug last month.
While there had been some risks to filgotinib's approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
An analyst wrote that while filgotinib's profile appears clean overall, even minor safety imbalances could derail its approval, while a slight imbalance in the number of deaths between the Phase III study arms could also attract scrutiny.
Reuters reported that the drug, Rinvoq, will carry a list price of $59,000 per year. AbbVie's top-selling drug, Humira, is also approved for treating RA.
The collaboration includes six drugs in development and more than 20 in preclinical development. It also amends an existing four-year-old partnership the two companies had regarding the autoimmune disease drug filgotinib.
The timing of the filing appears to allay concerns that the FDA would require completion of a study evaluating the testicular safety of the drug, filgotinib, and thus push its launch date from 2020 to 2021-22, an analyst wrote.
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An expert pointed to the draft guidance's lack of distinction between immune-activating bispecifics and those that do not activate the immune system, as well as potentially burdensome trials industry may have to conduct. The comment period ended Tuesday.
Whether the FDA requires completion of a study to look at testicular toxicity before approval could dictate whether the drug launches next year or as late as 2022, an analyst wrote.
With a list price 30% lower than the top TNF-alpha inhibitors, Regeneron and Sanofi's Kevzara could make waves in the blockbuster rheumatoid arthritis market.
Keep the champagne on ice. In an unexpected twist, the FDA has requested more dosage and safety data for Eli Lilly's baricitinib (Olumiant) — a delay that could cost millions.
Rheumatoid arthritis patients given a single intravenous dose of Mesoblast's novel stem cell therapy were still demonstrating therapeutic benefits nine months later, according to new Phase 2 data from the Melbourne, Australia-based company.