FDA rejects AZ’s subQ Saphnelo, but company expects quick turnaround for new approval decision
The FDA has rejected AstraZeneca’s subcutaneous version of lupus treatment Saphnelo, but the company is moving quickly to address the regulator’s concerns. (AstraZeneca) AstraZeneca has hit what appears to be a minor speed bump in gaining clearance in the U.S. for its subcutaneous (SC) version of lupus treatment Saphnelo. The FDA has sent the British drugmaker a […]
Rheumatologists view CAR T-cell therapy as ‘revolutionary,’ but cost, safety temper enthusiasm
Although rheumatologists consider chimeric antigen receptor T-cell therapy “potentially transformative,” nearly 70% remain hesitant on whether its efficacy outweighs the possible risks, according to survey data from Spherix Global Insights. “We are standing at the threshold of major change in rheumatology,” Sawyer May, insights director of rheumatology at Spherix Global Insights, told Healio. “The survey data and clinical experience […]
Rheumatologists Sharpen Differentiation Across the SLE Pipeline as Late-Stage Assets Crystallize into More Defined Clinical Roles, According to Spherix Global Insights
Nearly half of US rheumatologists expect Gazyva to meaningfully reshape SLE treatment pathways, while CAR T-cell therapy is viewed as applicable to only a small, refractory subset of patients EXTON, PA, January 20, 2026 – Updated findings from the Q4 2025 Market Dynamix™: SLE, Pipeline Refresh reveal a maturing and increasingly stratified development landscape, as US rheumatologists move from broad enthusiasm toward more selective, indication-driven […]
AZ looks to grow reach in lupus with phase 3 win for self-administered Saphnelo
The full results from AstraZeneca’s phase 3 Tulip-SC trial build on the interim results that earned the drug a European approval last month. Fresh off of a European approval for a subcutaneous version of Saphnelo, AstraZeneca is doubling down on the benefits of the self-administered drug formulation in lupus patients with a positive phase 3 […]
Approval of Roche/Genentech’s Gazyvaro Set to Reshape the EU5 Lupus Nephritis Treatment Landscape, According to Spherix Global Insights
Strong physician readiness, high efficacy expectations, and anticipated displacement of off-label rituximab position Gazyvaro for rapid adoption across Europe EXTON, PA, December 11, 2025 — Following this week’s European Commission approval of Roche/Genentech’s Gazyvaro (obinutuzumab) for the treatment of lupus nephritis (LN), Spherix Global Insights’ latest RealTime Dynamix™: Lupus Nephritis (EU) study indicates that the […]
First Look at Roche/Genentech’s Gazyva Shows Strong Early Enthusiasm in Lupus Nephritis Launch, According to Spherix Global Insights
One-month post-launch, Gazyva’s perceived degree of advance exceeds benchmarks achieved by GSK’s Benlysta and Aurinia’s Lupkynis at comparable post-launch time points. EXTON, Pa., November 19, 2025 – Spherix Global Insights has released the first wave of Launch Dynamix™: Gazyva in Lupus Nephritis, providing the earliest independent read on the commercial introduction of Gazyva® (obinutuzumab, Genentech/Roche). […]
UCB’s Bimzelx and AbbVie’s Rinvoq Lead in EU5 Psoriatic Arthritis, Ankylosing Spondylitis, and Non-Radiographic Axial Spondyloarthritis Growth
New insights from Spherix Global Insights reveal strong rheumatologist anticipation for next-generation oral and multi-pathway innovations, including Sotyktu, icotrokinra, and sonelokimab. EXTON, PA, November 13, 2025 – The 2025 Market Dynamix™: Psoriatic Arthritis and Ankylosing Spondylitis/Non-Radiographic Axial Spondyloarthritis (EU5) studies from Spherix Global Insights reveal a rapidly evolving treatment landscape, as rheumatologists expand use of […]
Novel Pipeline Activity Signals Hope in Systemic Sclerosis, as Rheumatologists Anticipate First Real Therapeutic Advances in Years
Familiarity with AstraZeneca’s Saphnelo and enthusiasm for next-generation biologics signal increasing optimism, though CAR T-cell therapy divides opinion amid safety and access concerns, according to Spherix Global Insights EXTON, PA, November 6, 2025 – According to the latest Market Dynamix™: Systemic Sclerosis (US) 2025 study from Spherix Global Insights, the treatment landscape for systemic sclerosis […]
Sjögren’s Disease Remains an Underdiagnosed and Underguided Condition, Creating an Opening for Manufacturers to Shape the Future of Care, According to Spherix Global Insights
With multiple late-stage assets advancing, manufacturers have a near-term opportunity to drive much-needed disease education and shape therapeutic direction. EXTON, PA, October 16, 2025 – Sjögren’s Disease (SjD) continues to present significant diagnostic and therapeutic challenges within rheumatology, according to Spherix Global Insights’ Market Dynamix™: Sjögren’s Disease (US) 2025 report. Despite growing awareness and expanding […]
Priovant’s Brepocitinib Poised to Address Steroid-Sparing Gap in Dermatomyositis as Rheumatologists Anticipate 2026 Launch
Physician sentiment captured in Spherix Global Insights’ research highlights high expectations for dual TYK2/JAK1 inhibition, with continued unmet needs across the broader IIM spectrum. EXTON, PA, October 10, 2025 – Rheumatologists are eagerly anticipating the potential approval of brepocitinib, Priovant Therapeutics’ dual TYK2/JAK1 inhibitor, as a near-term advance for dermatomyositis (DM). According to Spherix Global […]
