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Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

(RA) burden has significantly increased worldwide, according to a large AI-powered study that also revealed local hotspots and a growing trend of RA in younger people.

“While previous Global Burden of Disease (GBD) studies have provided important insights, they have largely focused on high-level descriptions and visualizations at global and national scales, failing to capture local disparities or the dynamic interactions between socioeconomic development and disease trends,” principal investigator Queran Lin, MPH, WHO Collaborating Centre for Public Health Education and Training, Faculty of Medicine, Imperial College London; and Clinical Research Design Division, Clinical Research Centre, Sun Yat-Sen Memorial Hospital, Guangzhou, said in a statement.

 “With access to sufficient computational resources and advanced analytical capabilities, our Global-to-Local Burden of Disease Collaboration aims to unlock the full potential of the GBD dataset (pioneered by the Institute for Health Metrics and Evaluation, University of Washington). By employing cutting-edge approaches such as transformer-based deep learning models, we were able to generate the most granular disease burden estimates to date, offering a new framework for guiding precision public health across diverse populations.”

In the study, Lin and colleagues analyzed the prevalence, incidence, mortality, disability-adjusted life years (DALYs), years of life lost (YLLs), and years lived with disability (YLDs) of RA across 953 locations worldwide. They also looked at inequalities and ideal frontiers of these measures and developed a deep-learning pipeline to forecast long-term burdens with scenario simulations.

The investigators found that RA incidence rose by 13.2% from 1990 to 2021, in which it affected 17.9 million people globally, with the affected population growing younger and broader. While the age-standardized death rate fell 32.7% from 1980 to 2021, global DALYs nearly doubled from 1990 to 2021.

“The adoption of this advanced framework quantifies the expected impact of feasible intervention scenarios in public health, supplying policymakers at global, national, and local levels with more reliable, dynamic evidence, redefining the very paradigm of health surveillance,” co-lead investigator Wenyi Jin, MD, PhD, Department of Orthopedics, Renmin Hospital of Wuhan University; and Department of Biomedical Sciences, City University of Hong Kong, said.

Lin and colleagues also sought to identify local hotspots of RA. They found that in 2021, among 652 subnational regions, West Berkshire in the UK had the highest age-standardized incidence rate (35.1; 95% CI, 30.8-39.8) and Zacatecas in Mexico had the highest age-standardized DALY rate (112.6; 95% CI, 87.2-142.7). From 1990 to 2021, regions with high sociodemographic index (SDI) experienced the greatest burden of disease, with disparities widening over time. More than 90% of regions fell behind across frontiers of multiple key RA indicators.

Japan was a notable exception, showing a consistent decline in disease burden, with Tokyo’s age-standardized DALY rate dropping by 22.4% during this period, in contrast to trends seen in other high SDI areas. The investigators’ projections suggest that implementing smoking reduction measures could lead to a 16.8% decrease in RA-related mortality and a 20.6% reduction in DALYs among men in high-smoking countries like China.

“Japan’s sustained decline in DALYs despite a high SDI proves that socioeconomic status alone doesn’t dictate outcomes; proactive healthcare policies such as early diagnosis programs can reverse trends,” co-lead investigator Baozhen Huang, PhD, Department of Biomedical Sciences, City University of Hong Kong, added.

Jin W, Wang Q, Jin C, et al. Spatiotemporal distributions and regional disparities of rheumatoid arthritis in 953 global to local locations, 1980-2040, with deep learning-empowered forecasts and evaluation of interventional policies’ benefits. 

AI-Powered Study Shows Surge in Global Rheumatoid Arthritis Since 1980, Revealing Local Hotspots. News release. Elsevier. June 16, 2025. 

https://www.elsevier.com/about/press-releases/ai-powered-study-shows-surge-in-global-rheumatoid-arthritis-since-1980

Articles

A comprehensive AI-powered study has revealed a significant global increase in rheumatoid arthritis (RA) burden, with a notable rise in younger populations. The study utilized advanced deep-learning models to analyze RA prevalence, incidence, mortality, and disability-adjusted life years (DALYs) across 953 locations. Findings indicate a 13.2% rise in RA incidence from 1990 to 2021, despite a 32.7% decrease in age-standardized death rates. Local hotspots were identified, with disparities widening in high sociodemographic index regions. Japan's proactive healthcare policies have successfully reduced RA burden, highlighting the impact of targeted interventions.

Populations most affected by RA are also growing younger and broader since 1990.

News

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Rheumatoid Arthritis

The HCPLive rheumatoid arthritis page is a comprehensive resource for clinical news and insights on arthritis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for RA, and more.

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Rheumatoid Arthritis Burden Has Surged Over Last 30 Years

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Ulugbek Nurmatov, MD, PhD | Image Credit: Liverpool School of Tropical Medicine

According to a recent systematic review and meta-analysis examining the safety and efficacy of omalizumab (OMA) and similar biologics in treating IgE-mediated 

, patient-specific factors are a critical concern when attempting to reduce food-induced allergic reaction risk.

Although oral immunotherapy (OIT) has long been effective in desensitizing patients to specified allergens, several limitations, such as a lack of standardization and adverse effects, limit its use. Biologics, however, are more broadly applicable, as they target underlying immunologic pathways driving allergic reactions. OMA is the most studied biologic in this space; it has been approved for both adjunct therapy with oral immunotherapy and as a monotherapy.

“The use of biologics, either as monotherapy or in combination with OIT, offers a cutting-edge approach to FA management,” wrote Ulugbek Nurmatov, MD, PhD, division of population medicine, School of Medicine, Cardiff University, and colleagues. “However, despite the growing body of research, the optimal use of biologics in FA treatment, including timing, duration, combination strategies, and cost-effectiveness remains to be fully elucidated.”

Investigators collected data from medical databases including Cochrane Library, EMBASE, and ISI Web of Science, for randomized controlled trials (RCTs) examining biologics as monotherapy or in conjunction with OIT. Inclusion criteria were as follows:

A population comprised of children (≤18 years) and adults (>18 years) with IgE-mediated FA confirmed by oral food challenge

Biological therapy intervention (monotherapy or combined with OIT)

A placebo comparator, no intervention, or routine management without active treatment

The primary outcomes included desensitization, sustained unresponsiveness or persistent desensitization, and biologics-related adverse reactions, including severe adverse events. Secondary outcomes included immunological outcomes such as skin prick testing (SPT), serum specific IgE and IgG4 concentrations, and total IgE levels, as well as quality of life (QoL) measures.

The team collected an initial total of 7791 relevant papers; 7719 were then excluded as either duplicates or irrelevant. An additional 9 uncontrolled studies, 8 observational studies, and 42 abstract papers were excluded. A final total of 13 RCTs and 2 US National Clinical Trials (NCTs) were included in the systematic review. Of these, 9 were assessed as having low risk of bias, 3 as moderate, and 1 as high risk.

A total of 1010 patients were included across the studies, with ages ranging from 1-60 years. Among these, 7 studies included both adults and children, 5 focused exclusively on adolescents, and 1 enrolled only adult patients.

All 13 included RCTs reported desensitization as an outcome; meta-analysis was conducted on pooled data from 10, as the remaining 3 were omitted due to heterogeneity. This analysis indicated an increased likelihood of tolerating 2g of protein from 2 foods, namely peanut and cow’s milk, with OMA as monotherapy or OMA with OIT compared to control (risk ratio [RR], 2.035; 95% CI, 1.29 to 3.22; 299 participants, 7 studies, I

 = 50%, GRADE = moderate). Sensitivity analysis supported this finding (RR, 2.41; 95% CI, 1.38 to 4.2; 232 participants, 6 studies, I

Additionally, OMA increased food tolerance thresholds compared to placebo (RR, 4.9; 95% CI, 2.14 to 11.20; 235 participants, 3 studies, I

= 0%, GRADE = moderate). Regarding adverse effects, OMA reduced the risk of allergic reactions (RR, .55; 95% CI, .36 to .85) without increasing skin (RR, 1.09; 95% CI, .45 to 2.65) or other adverse or severe reactions. Investigators also noted a decrease in hypersensitivity and a lowered allergic and inflammatory response.

Despite noting this study as the most robust investigation to date within this sphere, investigators did note the key limitations of heterogeneous populations, interventions, outcomes, diversity of biologics, OIT protocols, and treatment modalities.

“More studies with long-term outcomes are needed to establish the effectiveness, tolerability and safety of biologics as a monotherapy or in combination with OIT,” Nurmatov and colleagues wrote. “In addition, standardized definitions and reporting of AEs and Ars secondary to treatment will allow for more comprehensive analysis and comparisons. Research on cost-effectiveness and quality of life impacts is also necessary to guide patient-centred care.”

Nurmatov UB, Lo Scalzo L, Galletta F, et al. Biologics in IGE-mediated food allergy: A systematic review and meta-analysis of Interventional Studies. World Allergy Organization Journal. 2025;18(7):101069. doi:10.1016/j.waojou.2025.101069

Sindher SB, Fiocchi A, Zuberbier T, Arasi S, Wood RA, Chinthrajah RS. The role of biologics in the treatment of food allergy. The Journal of Allergy and Clinical Immunology: In Practice. 2023;12(3):562-568. doi:10.1016/j.jaip.2023.11.032

Omalizumab and similar biologics show promise in treating IgE-mediated food allergies, offering an alternative to oral immunotherapy (OIT) by targeting immunologic pathways. A systematic review and meta-analysis of randomized controlled trials (RCTs) found that biologics, either alone or with OIT, increased food tolerance and reduced allergic reactions. However, the study highlighted limitations such as heterogeneous populations and interventions. Further research is needed to determine the long-term effectiveness, safety, and cost-effectiveness of biologics in food allergy management.

New research has indicated increased food tolerance thresholds and desensitization from omalizumab and other biologics in comparison to placebo with no serious adverse effects.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Food Allergy

Biologic Treatments Safe to Recommend for IgE-Mediated Food Allergy, Study Suggests

Teresa Lillis, PhD, Rush University Medical Center.

Wearables Show Disrupted Sleep 3 Months Postpartum, with Teresa Lillis, PhD

, Lillis discussed how wearable data revealed

 up to 13 weeks postpartum despite total sleep duration nearing pre-pregnancy levels.

At SLEEP 2025, Teresa Lillis, PhD, from Rush University Medical Center, presented new research findings that sleep duration gradually returned near baseline levels after the first week postpartum, but sleep consolidation stayed below pre-pregnancy levels throughout the first 13 postpartum weeks.

 to discuss the implications of these findings: What strategies should clinicians consider recommending to improve consolidated sleep for new mothers? Could consumer-grade wearables become a viable tool in postpartum clinical monitoring?

“I can't say enough good things about my experience working in wearable data here. You cannot get this level of detail with traditional lactography,” Lillis said.

In Lillis and colleagues’ study, 41 participants wore Fitbits that tracked sleep duration and longest stretch of sleep for 2 years: a full year before birth, during pregnancy, and a full postpartum year.

“That really allowed me to get the bird's eye view of what was going on with these moms,” Lillis said. “That helped me visualize just how…chunky sleep is after baby comes. Now, my personal experience as a mom told me that that's what happens to my sleep from the postpartum, but I wouldn't have been able to demonstrate that across all 40 women to have [those] same chunky patterns in the postpartum, had I not had access to wearable data. Moving forward, wearables are exactly the tools we need to help demystify or better understand what's going on with women's physiology, both during pregnancy and in the postpartum.”

Sleep duration reduced to near baseline levels (7.8 hours) during postpartum week 1 (4.4 hours), postpartum weeks 2 – 7 (6.7 hours), and postpartum weeks 8 – 13 (7.3 hours). The mean daily longest stretch of sleep fluctuated from 5.6 hours at pre-pregnancy, 2.2 hours during the first postpartum week, 3.2 hours during postpartum weeks 2 – 7, and 4.1 hours during postpartum weeks 8 – 13 (

Lillis said that the data was clinically meaningful and emphasized the need for postpartum women to receive better federal support. The study validates postpartum women’s sleep disturbances.

“I wrote my dissertation on postpartum sleep, and I was not prepared for how bad it was when I had my baby,” Lillis said. “So, I want this… data to prepare women and validate them.”

Lillis T, Hansen D, and Dongen H. Profound Postpartum Sleep Discontinuity In First-Time Mothers. Presented at SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies, from June 8th – 11th in Seattle.

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At SLEEP 2025, Lillis discussed how wearable data revealed disruptions in sleep consolidation up to 13 weeks postpartum despite total sleep duration nearing pre-pregnancy levels.

Sleep

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Wearables Show Disrupted Sleep 3 Months Postpartum, With Teresa Lillis, PhD

Abigail Brooks is an assistant editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Regeneron Pharmaceuticals and Sanofi have announced positive results from the EVEREST phase 4 trial in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting 

, highlighting dupilumab (Dupixent)’s superiority to omalizumab (Xolair) for all primary and secondary efficacy endpoints of CRSwNP, and in all asthma-related endpoints.

The data represent the first-ever presented head-to-head respiratory trial with biologic medicines and were shared in a late-breaking oral presentation at the 2025 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress.

“Patients suffering from chronic rhinosinusitis with nasal polyps often live with the constant obstruction of their nasal passages that can lead to burdensome nasal congestion and loss of smell. What’s more, a majority of these individuals also have asthma that can substantially impact their quality of life,” Eugenio De Corso, MD, PhD, ENT Specialist, Otolaryngology, Head and Neck Surgery, Rhinology, A. Gemelli University Hospital Foundation, IRCSS, Rome, Italy, and lead investigator of the study, said in a press release.

 “EVEREST is the first-ever trial to demonstrate the superiority of Dupixent over Xolair on CRSwNP endpoints in patients with coexisting asthma, along with generally similar safety profiles. Together, these Dupixent outcomes provide important insights that will help guide patients and physicians through the treatment decision-making process.”

A fully human monoclonal antibody, dupilumab inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. Its clinical development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 trials, establishing IL-4 and IL-13 as 2 key and central drivers of the type 2 inflammation that plays a major role in multiple related and often comorbid diseases.

Dupilumab has received regulatory approvals in > 60 countries in 1 or more indications. In 2018, it was granted US Food and Drug Administration approval for the treatment of moderate-to-severe asthma. In 2019, it was approved for the treatment of adults with uncontrolled CRSwNP, which was later expanded in 2024 to include adolescents 12-17 years of age.

A randomized, double-blind phase 4 trial, EVEREST compared the efficacy and safety of dupilumab to omalizumab in adults with severe, uncontrolled CRSwNP and coexisting mild, moderate or severe asthma. During the 24-week trial, patients received dupilumab 300 mg every 2 weeks or omalizumab 75 to 600 mg every 2 or 4 weeks, which was added to background MFNS. Omalizumab dosing was determined based on body weight and serum total IgE levels as per the approved label.

The primary endpoints assessed change from baseline in nasal polyp score and the University of Pennsylvania Smell Identification Test. Secondary endpoints included change from baseline in nasal congestion, loss of smell, total symptom score, Sino-Nasal Outcome Test-22, peak nasal inspiratory flow, and rhinosinusitis disease severity. Other endpoints assessed pre-bronchodilator forced expiratory volume over one second and the 7-item Asthma Control Questionnaire.

Primary and secondary endpoint results in CRSwNP for patients treated with dupilumab compared to omalizumab at 24 weeks were as follows, with differences seen as early as 4 weeks:

1.60-point superior reduction in nasal polyp size (

8.0-point superior improvement in ability to identify different smells (

0.58-point superior reduction in nasal congestion/obstruction (

0.81-point superior improvement in loss of smell (

1.74-point superior reduction in symptom severity (

12.7-point difference in health-related quality of life (

31.27-point difference in peak nasal inspiratory flow (

1.87-point difference in overall severity of rhinosinusitis (

Asthma endpoint results for patients treated with dupilumab compared to omalizumab at 24 weeks were as follows, with differences again seen as early as 4 weeks:

150 mL difference in lung function (pre-bronchodilator FEV1; 

0.48-point difference in asthma control (

According to a press release from Regeneron, the safety results in the EVEREST trial were consistent with the known safety profile of dupilumab in its approved respiratory indications, with similar overall rates of adverse events (AEs) observed between dupilumab (64%) and omalizumab (67%). Serious AEs were reported in 2% and 4% of patients treated with dupilumab and omalizumab, respectively.AEs leading to trial discontinuation were reported in 3% of dupilumab patients and 1% of omalizumab patients.

Regeneron. Dupixent® (dupilumab) Demonstrated Superiority Over Xolair® (Omalizumab) in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) in Patients with Coexisting Asthma in First-ever Presented Phase 4 Head-to-Head Respiratory Trial. June 15, 2025. Accessed June 18, 2025. 

https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-demonstrated-superiority-over-xolairr

Regeneron. FDA Approves Asthma Indication for Dupixent® (dupilumab). October 19, 2018. Accessed June 18, 2025. 

https://investor.regeneron.com/news-releases/news-release-details/fda-approves-asthma-indication-dupixentr-dupilumab

FDA Approves Dupixent® (dupilumab) for Chronic Rhinosinusitis with Nasal Polyposis. June 26, 2019. Accessed June 18, 2025. 

https://investor.regeneron.com/news-releases/news-release-details/fda-approves-dupixentr-dupilumab-chronic-rhinosinusitis-nasal

Smith T. FDA Approves Dupilumab for Adolescents with Chronic Rhinosinusitis with Nasal Polyps. HCPLive. September 13, 2024. Accessed June 18, 2025. 

https://www.hcplive.com/view/fda-approves-dupilumab-for-adolescents-chronic-rhinosinusitis-with-nasal-polyps

Regeneron Pharmaceuticals and Sanofi's EVEREST phase 4 trial demonstrated dupilumab's superiority over omalizumab in treating severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma. Dupilumab showed significant improvements in nasal polyp size, smell identification, nasal congestion, and asthma control, with differences observed as early as four weeks. The trial, the first head-to-head comparison of biologics for respiratory conditions, confirmed dupilumab's efficacy and safety, aligning with its known profile. These findings provide valuable insights for treatment decision-making in patients with CRSwNP and asthma.

Phase 4 data highlight dupilumab’s superiority to omalizumab for all primary and secondary efficacy endpoints of CRSwNP, and in all asthma-related endpoints.

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

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EVEREST: Dupilumab (Dupixent) Outperforms Omalizumab (Xolair) for CRSwNP, Asthma

Aquestive Therapeutics has announced that the US Food and Drug Administration (FDA) acceptance of the Company’s New Drug Application (NDA) for epinephrine (Anaphylm) sublingual film for the treatment of 

Announced on June 16, 2025, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026. According to a release from Aquestive, the agency reiterated that it may decide to conduct an Advisory Committee meeting for the approval of epinephrine sublingual film. If approved, it would be the first and only orally delivered epinephrine option for the treatment of severe allergic reactions in the United States.

"Anaphylaxis is an unpredictable, severe allergic reaction that can be life-threatening within minutes. While epinephrine remains the only FDA-approved first-line treatment, too many at-risk individuals don't carry it consistently or hesitate to use it when seconds count," David Stukus, MD, a professor of clinical pediatrics and director of the Food Allergy Treatment Center at Nationwide Children’s Hospital and The Ohio State University College of Medicine, said in a statement.

 "The reality is stark: epinephrine can only save lives if people have it available and feel confident using it immediately. This potential drug product addresses the two biggest barriers we hear from patients – fear of administration and the inconvenience of carrying bulky devices. An oral, no-needle approach could be transformative for anaphylaxis care."

Epinephrine sublingual film is a polymer matrix-based epinephrine prodrug product candidate. It is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact, with no water or swallowing required for administration. As described by Aquestive, the packaging is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight.

“Anaphylm represents a breakthrough in anaphylaxis treatment, if approved by FDA, being the first and only device-free, orally delivered epinephrine medicine,” said Dan Barber, president and chief executive officer of Aquestive.

 “We designed Anaphylm to fit seamlessly into the patient’s daily life. It’s thinner than a credit card and requires no special storage, so patients can keep it in their phone case, wallet, or pocket – Anaphylm can go everywhere you go, without the bulk of even the smallest FDA-approved device for this patient population.”

In the Oral Allergy Syndrome challenge study of adults with allergen-induced oral physiological change, epinephrine sublingual film achieved key primary and secondary endpoints for resolving symptoms of severe allergic reactions, such as anaphylaxis. Results showed the rapid resolution of allergen-related symptoms began 2 minutes after administration, with a comparable pharmacokinetic profile after allergen exposure to a non-allergen profile.

Aquestive Therapeutics received positive feedback from the FDA on epinephrine sublingual film for the treatment of severe allergic reactions, including anaphylaxis, in December 2024 during a pre-NDA meeting, reaffirming the Company’s plans for an NDA submission in Q1 of 2025 with no additional adult clinical trials required before application.

Later, in April 2025, Aquestive announced positive topline results from its pediatric study for epinephrine sublingual film in patients 7-17 years of age weighing > 30 kilograms with a personal history of allergic reactions, marking the completion of its clinical program and supporting the clinical data needed for the NDA submission.

The pediatric study was a multi-site, single treatment study designed to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of epinephrine sublingual film. A total of 32 patients completed the study, and pharmacokinetic results were consistent with previous adult studies. Of note, epinephrine sublingual film was shown to be safe and well-tolerated with no serious adverse events reported.

“Our clinical data demonstrates Anaphylm’s ability to rapidly deliver epinephrine absorption orally,” Barber said in a statement.

 “With the FDA’s acceptance of our NDA, we’re one step closer to getting this life-saving innovation in the hands of the patients and caregivers who need it most.”

Aquestive Therapeutics. Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions. June 16, 2025. Accessed June 19, 2025. 

https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-announces-fda-acceptance-new-drug-0

Iapoce C. Anaphylm Sublingual Film Achieves Rapid Resolution of Allergen-Related Symptoms. 

. October 24, 2024. Accessed June 19, 2025. 

https://www.hcplive.com/view/anaphylm-sublingual-film-achieves-rapid-resolution-of-allergen-related-symptoms

Iapoce C. Anaphylm Sublingual Film for Anaphylaxis Receives Positive FDA Feedback. 

. December 2, 2024. Accessed June 19, 2025. 

https://www.hcplive.com/view/anaphylm-sublingual-film-for-anaphylaxis-receives-positive-fda-feedback

Derman C. Aquestive’s Anaphylm for Severe Allergic Reactions Shows Promise in Children. 

. April 1, 2025. Accessed June 19, 2025. 

https://www.hcplive.com/view/aquestive-s-anaphylm-for-severe-allergic-reactions-shows-promise-in-children

Aquestive Therapeutics has received FDA acceptance for its New Drug Application for Anaphylm, a sublingual film for treating Type 1 allergic reactions, including anaphylaxis. If approved, it would be the first orally delivered epinephrine option in the U.S., addressing barriers like fear of administration and device bulkiness. The film dissolves on contact, requires no water, and is easily portable. Clinical studies demonstrated rapid symptom resolution and safety in both adults and children. The FDA's decision is expected by January 31, 2026.

With the FDA acceptance of the NDA, the agency has assigned a PDUFA target action date of January 31, 2026, and may require an Advisory Committee meeting for approval.

FDA News

Anaphylaxis

The HCPLive anaphylaxis page is a comprehensive resource for clinical news and insights on acute allergic reactions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for preventing anaphylaxis, and more.

FDA Accepts Epinephrine (Anaphylm) Sublingual Film NDA for Type 1 Allergic Reactions

Melinda Gooderham, MD, MSc, joins The Medical Sisterhood to discuss balancing mentorship, leadership, and family, as well as the empowerment of women in the medical field.

The Medical Sisterhood, with Mona Shahriari, MD

The Medical Sisterhood, hosted by Mona Shahriari, MD, is a podcast dedicated to empowering female physicians by providing a platform for shared experiences, mentorship, and support. 

Each episode delves into the unique challenges women in medicine face, including work-life balance, leadership roles, and overcoming gender biases. Shahriari aims to inspire women to lead fulfilling professional and personal lives on their own terms through candid discussions and expert interviews. 

e as we foster a community where women can uplift and support each other in achieving their goals!

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The Medical Sisterhood—The Global Sisterhood: When She Speaks the World Listens

Panelists discuss how the new medication xanomeline trospium chloride represents a paradigm shift in schizophrenia treatment through its novel muscarinic agonist mechanism that targets presynaptic dopamine activity rather than traditional postsynaptic D2 blockade.

Video Series

Peers Perspectives

Schizophrenia

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Xanomeline/Trospium Chloride for Treatment of Schizophrenia

A panelist discusses how the underlying causes of resistant hypertension remain largely mysterious, though physicians must screen for secondary causes like cortisol-producing tumors or coarctation of the aorta while recognizing that some patients simply don’t respond to normally effective medications.

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Diagnosing Resistant Hypertension: Tools, Triggers, and Screening Tactics

Panelists discuss how to set realistic expectations with schizophrenia patients by being upfront and honest while establishing open communication and strong rapport from the beginning of treatment.

Realistic Expectations and Treatment Success in Schizophrenia

Systematic review and meta-analysis findings support recent guidelines advising against short-acting beta-agonist monotherapy for asthma management.

SABA Overuse Linked to Increased Mortality, Acute Exacerbations in Asthma

New research has associated complement factors from both the classical and terminal pathways with progression from intermediate to advanced age-related macular degeneration.

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Dysregulation of Complement Pathway May Increase Risk of AMD Progression

An overview of 7 presentations included as late-breaking clinical trials at ADA 2025.



Diabetes Dialogue

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a monthly podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

Type 1 Diabetes

Type 2 Diabetes

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ADA 2025 Late-Breaking Trials Preview

By week 2 postpartum, sleep duration rebounds, but fragmented sleep persists through week 13, Teresa Lillis, PhD, presented at SLEEP 2025.

Postpartum Sleep Improves in Length, Not Quality, With Teresa Lillis, PhD

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

This analysis highlights the observed risk of developing psoriasis when using dupilumab to treat atopic dermatitis.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

Dupilumab-Treated Patients with Atopic Dermatitis at Increased Risk of Psoriasis

The FDA approves Lenacapavir, a groundbreaking twice-yearly HIV prevention injection, revolutionizing PrEP options for adults and adolescents.

HIV/AIDS

The HCPLive HIV/AIDS page is a comprehensive resource for clinical news and insights on human immunodeficiency virus. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for HIV, and more.

Infectious Disease

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on viruses, infections, and bacteria. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for COVID-19, influenza, vaccine-preventable diseases, and more.

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