Artiva Biotherapeutics attributed one of the fatalities to a drug used to prepare patients for cell therapy and not to the cell therapy itself. But Artiva’s setbacks follow safety signals reported for autoimmune disease cell therapy programs from Novartis and Bristol Myers Squibb.
Medicare policy should be transparent and include appropriate notice and stakeholder input. And when a contractor gets it wrong, there should be a clear and rapid way to stop the harm to patients, their relationship with their doctor and the doctor’s practice.
We have the opportunity to design systems that give people greater capacity for the work where human presence matters most: listening, understanding, reassuring, deciding, and caring.
Dualitas Therapeutics designs bispecific antibodies to hit to two targets on the same immune cell, leveraging proximity biology to provide benefit beyond what’s possible with monoclonal antibody drugs. Eli Lilly and Chugai Pharmaceutical are among the investors in the immunology and inflammation startup.
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.
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.
What if health plans could identify member decline before an avoidable hospitalization occurs? Real-time clinical visibility into long-stay SNF members uncovers risk earlier and drives better outcomes.
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.
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.
Healthcare decision-makers, especially at pharmaceutical companies, must prioritize patient input. Data collected from social media listening is a significant step in the right direction.
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.
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.