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Pharma/Regulatory

Early RA Referral Clinics Work!

An outcomes study from the Leiden Early Arthritis Clinic (EAC) has shown substantially less diagnostic delay and better long-term outcomes when patients are referred to EAC compared to usual referrals.

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FDA Grants Priority Review to Zasocitinib for Plaque Psoriasis. Regulatory decision expected 1st quarter 2027. Supported by phase 3 RCTs, 3000 pts -- LATITUDE PsO 3001 and 3002 clinical trials. https://t.co/o7oqxSXHSw https://t.co/evzPtaTWI4
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Sobi Receives US FDA Fast Track Designation for pacritinib in VEXAS Syndrome. Pacritinib (Vonjo) is a kinase inhibitor (JAK2, FLT3) that is approved to treat adults with intermediate or high-risk myelofibrosis https://t.co/V7duJPyJpG https://t.co/Dn5DgeaX7N
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FDA Grants Fast Track Designation to treprostinil inhalation powder (Yutrepia - currently FDA approved to tx Pulm HTN) for the Treatment of Raynaud’s Phenomenon assoc w/ Systemic Sclerosis. A Phase 2a RE-WARM dose-finding study will begin October 2026. https://t.co/x4X1Ld1egZ https://t.co/GsZ9LXJjre
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A Day of Infamy (9.11.2026)

Dr. Jack Cush reviews the news and journal reports from this past week on Rheumnow.com - including obesity, disappointing durability with GLP-1 drugs, AI diagnoses and worries about CV risk in ANCA-associated vasculitis. And take this week's RheumIQ quiz

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Sobi Receives US FDA Fast Track Designation for pacritinib in VEXAS Syndrome. Pacritinib (Vonjo) is a kinase inhibitor (JAK2, FLT3) that is approved to treat adults with intermediate or high-risk myelofibrosis https://t.co/V7duJPyJpG https://t.co/N9rg30EA4W
Dr. John Cush @RheumNow( View Tweet )

JAMA: Review of Adult Rheumatoid Arthritis

Smolen, Kerschbaumer, Aletaha, and Robinson have published a comprehensive review article of rheumatoid arthritis (RA) in JAMA, noting significant changes to our understanding and treatment guidelines.

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Novartis & BMS CAR-T Cell Trials on Hold Reuters and the Wall Street Journal report that both Novartis and Bristol Myers Squibb (BMS) have paused their autoimmune disease CAR-T cell trials due to safety concerns, including deaths. https://t.co/ffcAHhtdBh https://t.co/zKlFcBdEod
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Treating Obesity is Disease-Modifying (9.4.2026)

Dr. Jack Cush reviews the news and journal articles from the past week on RheumNow.com.  New drugs approved, new drugs halted and some drugs out of control. Ready to test your knowlege? Take this week's quiz!

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“ABCDE” Approach to Difficult-to-Treat Rheumatoid Arthritis

The proposed approach to difficult-to-treat rheumatoid arthritis is based on the EULAR definition (having failed 2 or more b/tsDMARDs). The authors provide guidance in the form of an easy acronym, A B C D E, which covers both diagnostic and therapeutic considerations.

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Novartis & BMS CAR-T Cell Trials on Hold

Reuters and the Wall Street Journal report that both Novartis and Bristol Myers Squibb (BMS) have paused their autoimmune disease CAR-

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FDA Approves Brepocitinib to Treat Dermatomyositis

The FDA and Priovant recently annouced approval of brepocitinib (Lisraya), a JAK1/TYK2 inhibitor, for the indication of adults with dermatomyositis (DM). This is the first oral (once daily) agent approved for DM.

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CAR-T Reality Check! The hype is outrunning the evidence, which now lives in a handy dashboard created and presented by Dr. Mike Putman @EBRheum. There are almost as many studies as there are CAR-T treated patients. Few numbers, limited F/U - Yet everyone is gaga about CAR-T. https://t.co/6tLLJDVI8x
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NME: New Molecular Entities (8.28.2026)

Dr. Jack Cush reviews the news and journal articles from this past week on RheumNow.com. Take this week's RheumIQ and test your knowledge!

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Phase 1/2 COMPARE trial of CD19 CAR-T Rx in 6 ACPA+ RA pts w/ severe refractory Dz; after lymphodepletion, given mivocabtagene autoleucel (miv-cel), followed < 52wks. All had CRS, No ICANSs or serious AEs. All had CD19 cell depletion & Decr in AutoAbs. Efficacy: 3/6 had ACR70 & https://t.co/qfSdq2g0rk
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Secukinumab in Polymyalgia Rheumatica

Polymyalgia rheumatica (PMR) is a common disorder of the elderly that responds well to glucocorticoids (GC), but is plagued by an inability to wean off of GCs.
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Insights into Sjögren’s Disease - A Rheum Survey

RheumNow recentlty surveyed rheumatologists about Sjogren’s disease (SjD) - how they approach diagnosis, treatment, and unique challenges; all important as new advances in SjD evolves.

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Brepocitinib Skin Outcomes in Patients With Dermatomyositis

A secondary analysis of the VALOR trial has shown that the TYK2/JAK1 inhibitor brepocitinib was effective at cutaneous disease activity outcomes, delivering rapid, clinically meaningful, and remission-level control of cutaneous dermatomyositis (DM).

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CAR-T Reality Check! The hype is outrunning the evidence, which now lives in a handy dashboard created and presented by Dr. Mike Putman @EBRheum. There are almost as many studies as there are CAR-T treated patients. Few numbers, limited F/U - Yet everyone is gaga about CAR-T. https://t.co/aCtA8il2fD
Dr. John Cush @RheumNow( View Tweet )
Registry Data Shows Liver Risk With Avacopan A new study may add fuel to the fire already burning around avacopan (Tavneos), approved in 2021 to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV), which the FDA wants drugmaker Amgen to pull from https://t.co/nHF6RVpq2Z
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Age-specific Incidence of Systemic Lupus Erythematosus

Epidemiologic estimates on systemic lupus erythematosus (SLE) diagnosis are limited. The Centers for Disease Control and Prevention (CDC) National Lupus Registry network of population-based SLE registries has assessed and reported age-specific incidence of SLE

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JAK inhibitor Drug Market size (worldwide) was valued at $ 5.51 Billion in 2024 & is estimated to reach $ 19.81 Billion by 2033, exhibiting a Compound Annual Growth Rate of 13.66% from 2026-2033. https://t.co/1Krd1TeKv1 https://t.co/k0hx7iXTvn
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Registry Data Shows Liver Risk With Avacopan

MedPage Today

A new study may add fuel to the fire already burning around avacopan (Tavneos), approved in 2021 to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV), which the FDA wants drugmaker Amgen to pull from the U.S. market.

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EU Finalizes Tavneos Withdrawal - The European Commission has officially revoked the marketing authorization for Tavneos (avacopan), finalizing a process that began with regulators flagging the drug's pivotal trial data as "incorrect and misleading." The EC issued its legally https://t.co/jgysiV1hyX

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Doubting RS3PE (8.14.2026) Dr. Jack Cush reviews the news and journal articles this week where RheumNow featured info on cancer, deadly viruses, AI rules, poetry and good moons rising. https://t.co/gmcrjb5bDu https://t.co/LiLl7XcZQS
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