Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives

Triple agonism is reshaping expectations for weight loss in 

, a population historically less responsive to incretin-based therapy. New head-to-head phase 3 data show retatrutide more than doubled the weight reduction achieved with the highest approved dose of semaglutide (Ozempic).

Diabetes Dialogue: Retatrutide Tops Semaglutide on A1C, Weight in T2D

On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, reviewed topline results from the TRANSCEND-T2D-2 trial. Retatrutide is an investigational once-weekly agonist of the glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), and glucagon receptors.

The open-label trial randomized 1298 adults with type 2 diabetes to retatrutide 9 mg, retatrutide 12 mg, or semaglutide 2 mg. From a mean baseline A1C of 8.3%, both retatrutide doses lowered A1C by 2.2 percentage points at 80 weeks vs 1.8 points with semaglutide. From a mean baseline weight of 102.4 kg, weight fell 19.5% with retatrutide 9 mg and 20.9% with 12 mg vs 9.4% with semaglutide.

With both agents producing substantial glycemic reductions, individual weight goals may increasingly guide agent selection. Patients needing A1C lowering without large weight loss, such as frail older adults at risk for falls and fractures, may be better suited to semaglutide.

Gastrointestinal events were common across all arms, with more diarrhea on retatrutide, slightly more constipation on semaglutide, and comparable rates of nausea. Discontinuation due to adverse events, however, reached 4.8% with retatrutide 9 mg and 7.9% with 12 mg vs 2.7% with semaglutide. Slower titration in practice, and use of the 9 mg dose, may help preserve tolerability without sacrificing much efficacy.

Cardiovascular outcomes remain the largest open question. Semaglutide and tirzepatide (Mounjaro) both carry cardiovascular indications, while the cardiovascular effects of adding glucagon receptor agonism to GIP and GLP-1 activity are unknown. For patients with type 2 diabetes and established cardiovascular disease, agents with proven outcome benefit remain the preferred choice.

Retatrutide is not FDA-approved, and compounded products of uncertain composition should be avoided. Full TRANSCEND-T2D-2 results are expected at a future medical meeting, and a placebo-controlled trial in roughly 320 adults inadequately managed with basal insulin should report in 2027.

Collectively, the findings position retatrutide as a potential option for patients with type 2 diabetes who need substantial weight reduction. Tolerability at higher doses and forthcoming cardiovascular data will likely determine its place alongside established incretin therapies.

Editors’ Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

Eli Lilly. Lilly's retatrutide delivered greater A1C reduction and more than double the weight loss of Ozempic's highest approved dose in head-to-head trial. October 28, 2026. Accessed November 12, 2026. 

https://investor.lilly.com/news-releases/news-release-details/lillys-retatrutide-delivered-greater-a1c-reduction-and-more

Podcasts

TRANSCEND-T2D-2 topline data show retatrutide lowered A1C more and produced over twice the weight loss of semaglutide 2 mg in type 2 diabetes.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Type 2 Diabetes

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

This page also hosts content previously published by EndocrinologyNetwork. 


podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Diabetes Dialogue

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a 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.

Strategic Alliance Partnership

Gerard Criner, MD, is chair and professor of thoracic medicine and surgery at Lewis Katz School of Medicine at Temple University and director of the Temple Lung Center.

Global Initiative for Obstructive Lung Disease (GOLD) 2026 COPD International Conference

 in Philadelphia, adds more on the evidence and importance of mucus plugs in COPD.

Gerard Criner, MD, chair and professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University and director of the Temple Lung Center, discussed mucus plugging, multimorbidity, and exacerbation risk in an interview with 

Looking Beyond the Lungs in COPD Care, With Gerard Criner, MD

Criner moderated sessions on clinician education, covering inhaler technique, GOLD-guided assessment, and the use of oxygen, noninvasive ventilation, and high-flow nasal therapy in acute and chronic settings. He also moderated a plenary session on mucus plugs. Other sessions at the meeting examined mucus plug reduction with type 2 biologics and the updates in the 2027 GOLD Report.

“I think the most important things currently being talked about here are, first, the assessment of patients’ comorbid states and the multimorbidity they have, and to make people aware of the importance of being more global in their perspective of how COPD affects the patient, rather than just the lung,” Criner said.

Criner also pointed to the risk carried by a single moderate exacerbation. In the EXACOS-CV US cohort study, which Criner coauthored, a moderate exacerbation was associated with a higher 30-day risk of cardiovascular events (moderate HR=1.23 (95% CI 1.12— 1.35)) and death (moderate HR=1.22, 95% CI=1.04— 1.43).¹ He said the goal of therapy should be to capture the overall health, activity, and stability of the patient’s condition, rather than focusing on exacerbations alone.

Mucus plugging carries its own mortality signal. In a COPDGene analysis of 4363 participants published in 

, mortality reached 54.1 percent for patients with plugs in three or more lung segments, compared with 34 percent for patients with no detectable plugs.² Criner cited tozorakimab, an investigational anti-IL-33 monoclonal antibody not yet licensed for COPD, as 1 agent shown to reduce mucus plugging.

Looking ahead, Criner said much of what was discussed at the meeting will be incorporated into the 2027 GOLD Report. The aim, he said, is to take findings from the conference and the current literature and distill them into clinical guidance for clinicians caring for patients with COPD.

Editor’s Note: This Q&A transcript has been edited for grammar and clarity using artificial intelligence tools. Criner had no relevant financial disclosures of note.

Daniels K, Lanes S, Tave A, et al. Risk of death and cardiovascular events following an exacerbation of COPD: the EXACOS-CV US study. 

. 2024;19:225-241. doi:10.2147/COPD.S438893.

Diaz AA, Orejas JL, Grumley S, et al. Airway-occluding mucus plugs and mortality in patients with chronic obstructive pulmonary disease. 

. 2023;329(21):1832-1839. doi:10.1001/jama.2023.2065.

Videos

Gerard Criner, MD, discusses mucus plugging, multimorbidity, and moderate exacerbation risk in COPD from the GOLD 2026 conference in Philadelphia.

COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Tom Martens, MD, is a medical director at the International Diabetes Center at Park Nicolett Clinic and HealthPartners Care Group.

Continuous glucose monitoring (CGM) is standard of care in insulin-treated diabetes, but evidence for its use in 

 managed without insulin has lagged. New randomized data from the CONNECT trial suggest real-time CGM may substantially improve glycemic control in this much larger population.

Diabetes Dialogue: CONNECT Trial Backs CGM in Non-Insulin Type 2 Diabetes

On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, FNP-BC, spoke with Tom W. Martens, MD, of the International Diabetes Center, about CONNECT, recently published in the 

The trial enrolled 283 adults with type 2 diabetes who were not using insulin or CGM and had hemoglobin A1C levels of 7.5% or higher, across 22 primary care sites. Participants on stable non-insulin therapy were randomized 1:1 to real-time CGM with the Dexcom G7 or to routine fingerstick blood glucose monitoring (BGM) for 6.5 months. Both arms had the same number of brief, mostly virtual visits.

Mean A1C in the CGM group fell from 8.8% to 7.2%, a reduction of 1.6 percentage points. The BGM group improved from 8.7% to 8.0%, for a between-group difference of 0.9 percentage points. This gap is larger than those seen in earlier randomized CGM trials in insulin-treated type 2 diabetes, including MOBILE and DIAMOND.

Randomization was stratified by glucagon-like peptide-1 (GLP-1) receptor agonist use, reported by about 40% of participants at baseline. Among incretin users, A1C fell 1.4 percentage points with CGM vs 0.5 with BGM, the same 0.9-point difference. The benefit also held across other regimens, including sodium-glucose cotransporter 2 (SGLT2) inhibitors, used by about 30% of participants, and sulfonylureas.

More non-insulin therapies were added in the CGM arm. This may reflect access to continuous glucose data in place of infrequent A1C checks, which tend to reinforce clinical inertia. Much of the improvement appeared to come from lifestyle change, as participants could see postprandial excursions and link food choices to their glucose response.

The current American Diabetes Association (ADA) Standards of Care give CGM a grade C recommendation in non-insulin-treated type 2 diabetes. That grade reflects limited trial evidence, not proven lack of benefit. CONNECT may supply the randomized evidence needed for a grade A rating in the 2027 Standards, and payer coverage would likely follow over time.

A six-month extension, in which the BGM group switches to CGM, is still under way. Taken together, the findings suggest CGM adds to the effect of GLP-1 receptor agonists and other non-insulin therapies in primary care.

Editors’ Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others. Martens reports disclosures with Dexcom, Abbott Diabetes, Sanofi, MannKind, Zealand Pharma A/S, Lilly, and others.

Oser TK, Martens T, Ruedy KJ, et al. Continuous glucose monitoring in non–insulin-treated type 2 diabetes. New England Journal of Medicine. 2026;395(17):1717-1727. doi:10.1056/nejmoa2608571

Tom Martens, MD, joins Diana Isaacs, PharmD, and Natalie Bellini, DNP, to discuss CONNECT trial data on CGM in non-insulin-treated type 2 diabetes.

The American Academy of Dermatology (AAD) designates each November as National Healthy Skin Month, an observance launched in 1997 to encourage lifelong skin care habits and early detection of skin disease.¹ The 2023 US Preventive Services Task Force (USPSTF) recommendation assigns an I statement to clinician-performed visual 

 screening in asymptomatic adolescents and adults, leaving the decision to screen to clinical judgment.² The same statement notes melanoma is about 30 times more common in White persons than in Black persons, yet persons with darker skin are often diagnosed at later stages.²

Prevention tools are also shifting, as the 

 added bemotrizinol to the over-the-counter sunscreen monograph on June 9, 2026, the first new sunscreen active ingredient added since the late 1990s.³ Leigh Ann Pansch, MSN, FNP-BC, DCNP, clinical director of education at DOCS Dermatology Group, brings a dermatology nurse practitioner’s perspective to prevention and early detection across diverse patient populations.

 team, Pansch discusses year-round photoprotection, missed opportunities for early detection, counseling strategies, overlooked patient groups, and the developments clinicians should watch in the coming year:

: In light of National Healthy Skin Month, why does year-round photoprotection matter?

 The biggest message I want patients to take away is that sun protection is a 365-day commitment, not just a summer activity. One of the most common misconceptions I encounter is that sunscreen is only necessary when temperatures are high or when patients are spending extended time outdoors.

UV exposure doesn’t take a winter break. UVA rays penetrate clouds and glass and contribute to premature aging, DNA damage, and skin cancer risk throughout the year. Snow can also reflect UV radiation, increasing exposure during outdoor winter activities.

I encourage patients to make sunscreen part of their daily morning routine, just like brushing their teeth. I recommend a broad-spectrum SPF 30 or higher, along with protective clothing, hats, and seeking shade when appropriate.

I also remind patients that a history of tanning, sunburns, or cumulative UV exposure doesn’t disappear when summer ends. Prevention is about reducing ongoing exposure and protecting the skin over a lifetime.

: What are the most common missed opportunities for early skin cancer detection?

 One of the biggest missed opportunities is assuming that a skin cancer will always look like a changing mole. Patients and clinicians alike can overlook lesions that present as a nonhealing sore, a scaly patch, a pearly bump, or a persistent area of irritation or bleeding.

Another challenge is that skin examinations are not always incorporated into routine care. Primary care visits offer an important opportunity to ask about changing lesions, personal and family history of skin cancer, tanning bed use, and prior blistering sunburns.

Ask patients whether they have any new, changing, bleeding, or nonhealing lesions.

Identify patients with increased risk, including those with a personal history of skin cancer, significant UV exposure, immunosuppression, or a strong family history.

Perform a focused skin assessment when concerns or risk factors are identified.

Refer suspicious lesions promptly rather than taking a prolonged watch-and-wait approach.

Educate patients on the ABCDEs of melanoma and the importance of recognizing the “ugly duckling” sign.

We also need to emphasize that a concerning lesion deserves attention regardless of whether it is painful. Many skin cancers are asymptomatic in their early stages.

: What counseling strategies actually change patient behavior?

 I think one of the most important things we can do is move away from simply telling patients what they should do and instead help them understand how to make prevention realistic and sustainable.

Patients often know the recommendations but struggle with consistency. I find that counseling is more effective when it is personalized, practical, and nonjudgmental.

Make it simple: Recommend a sunscreen patients enjoy using and can afford. If they dislike the texture, smell, or appearance, they are less likely to use it consistently.

Connect prevention to existing habits: Encourage patients to apply sunscreen as part of their morning skincare routine, rather than treating it as an additional task.

Use visual education: Show patients examples of skin cancers, including what they can look like on different skin tones. Visual education can make the risks more tangible.

Set realistic expectations: Reinforce that sunscreen is one component of prevention. Protective clothing, hats, shade, and avoiding tanning beds are equally important parts of the conversation.

Encourage monthly skin checks: Suggest checking the skin on the same day each month, using a mirror or asking a partner to help examine hard-to-see areas. Taking baseline photographs can also help patients recognize changes over time.

I also try to avoid making patients feel guilty about past sun exposure. Instead, I focus on what they can do moving forward.

My goal is to make prevention feel achievable, not overwhelming. Consistency is more important than perfection, and small behavioral changes can have a meaningful impact over time.

: Which patient groups are most overlooked in skin cancer screening and prevention?

Patients with skin of color are an especially important population that deserves more attention. There is a persistent misconception that individuals with darker skin tones do not develop skin cancer or that melanin provides complete protection against UV damage. Neither is true.

Although melanoma is less common in Black patients than in White patients, it is often diagnosed at more advanced stages in patients with darker skin tones. This makes education, clinical awareness, and early evaluation particularly important.

We also need to recognize that melanoma may present differently in these populations. Acral lentiginous melanoma can develop on the palms, soles, fingers, toes, and underneath the nails. These may not receive significant sun exposure, so patients and clinicians may not immediately recognize them as potential sites of skin cancer.

Older adults: Particularly those with decades of cumulative UV exposure and a history of outdoor occupations.

Immunosuppressed patients: Including organ transplant recipients and patients taking immunosuppressive medications, who have increased risks of certain skin cancers.

Outdoor workers and athletes: Individuals with chronic occupational or recreational UV exposure who may not prioritize consistent sun protection.

Patients with limited access to dermatologic care: Those facing financial, geographic, insurance, or transportation barriers.

Patients with a personal or family history of skin cancer: Who may need more individualized surveillance and ongoing dermatologic follow-up.

For patients with skin of color, I think clinicians need to be especially intentional about education. We should discuss changes in pigmentation, nonhealing sores, unusual growths, and nail changes, while emphasizing examination of the palms, soles, and nail beds.

We also need better representation of diverse skin tones in clinical education and diagnostic training. If clinicians are primarily trained to recognize skin cancer on lighter skin, we risk missing important presentations in other populations.

Ultimately, skin cancer prevention and early detection should be inclusive, risk-based, and individualized. Skin tone should never be a reason to dismiss a concerning lesion.

: What developments in skin cancer prevention are you watching, and what should clinicians discuss in the coming year?

 There are several exciting developments in dermatology that I think will influence how we approach skin cancer prevention and early detection.

One particularly noteworthy development in 2026 is the FDA’s approval of bemotrizinol as a new over-the-counter sunscreen active ingredient. This is significant because it is the first new active sunscreen ingredient added to the U.S. OTC sunscreen monograph since the late 1990s.

I am interested in how newer sunscreen formulations may improve broad-spectrum protection, tolerability, and patient adherence. We should continue educating patients about choosing broad-spectrum SPF 30 or higher and finding formulations that work well with their individual skin types and concerns.

For patients with skin of color, tinted mineral sunscreens containing iron oxides are also worth discussing because they can provide additional protection against visible light, which can contribute to hyperpigmentation, particularly melasma.

Second, artificial intelligence and digital skin assessment.

AI-assisted lesion detection is an area I am watching closely. These technologies have the potential to help identify suspicious lesions, support clinical decision-making, and improve triage, particularly in settings with limited access to dermatologists.

However, I think it is important to emphasize that AI is an adjunct, not a replacement for clinical assessment. Emerging 2026 research continues to demonstrate limitations in real-world diagnostic performance, particularly with atypical lesions and populations that may be underrepresented in training datasets.

We need to ensure these technologies are validated across diverse skin tones and are used responsibly. A reassuring result from a smartphone application should never override clinical concern about a changing or suspicious lesion.

Third, evolving screening recommendations and personalized risk assessment.

I think clinicians should be familiar with the current USPSTF recommendation, which gives an I statement for routine clinician-performed visual skin cancer screening in asymptomatic adolescents and adults because evidence is insufficient to determine the overall balance of benefits and harms.

Importantly, this does not mean that suspicious lesions should go unevaluated or that higher-risk patients should not receive appropriate surveillance. Patients with concerning symptoms, a personal history of skin cancer, or significant risk factors require individualized clinical assessment.

I would like to see continued progress toward more personalized screening strategies that account for individual risk, diverse skin tones, family history, immunosuppression, and barriers to accessing dermatologic care.

Ultimately, the biggest opportunity is combining innovation with education and access to care. New sunscreen ingredients, AI technology, and improved diagnostic tools are exciting, but they do not replace the fundamentals: recognizing suspicious lesions, practicing consistent sun protection, performing regular skin self-examinations, and seeking timely evaluation.

As dermatology providers, we have an opportunity to make skin cancer prevention a routine part of patient education throughout the year, not just during Skin Cancer Awareness Month or the summer season.

Editor’s Note: This Q&A transcript has been edited for grammar and clarity using artificial intelligence tools.

American Academy of Dermatology. National Healthy Skin Month. Accessed November 12, 2026. 

https://www.aad.org/public/public-health/awareness-campaigns/national-healthy-skin-month

US Preventive Services Task Force. Screening for skin cancer: US Preventive Services Task Force recommendation statement. 

. 2023;329(15):1290-1295. doi:10.1001/jama.2023.4342.

US Food and Drug Administration. FDA expands sunscreen options for the first time in 20 years. Published June 9, 2026. Accessed November 12, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-expands-sunscreen-options-first-time-20-years

Articles

National Healthy Skin Month underscores durable photoprotection and earlier recognition of skin malignancies amid an USPSTF I statement for routine clinician visual screening in asymptomatic patients. UVA penetrates clouds and glass, and snow reflection amplifies exposure, supporting daily broad-spectrum SPF ≥30 plus protective behaviors. Missed diagnoses often stem from narrow “changing mole” expectations and absent skin assessment in routine care. Counseling should be personalized and habit-linked. Equity gaps persist in skin of color, where melanoma is less common yet later-stage, including acral and subungual sites. Emerging priorities include bemotrizinol OTC availability, AI-assisted assessment, and risk-stratified surveillance.

Leigh Ann Pansch, MSN, FNP-BC, DCNP, discusses year-round photoprotection, missed skin cancer detection, and overlooked patients for Healthy Skin Month.

Dermatology

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

Q&A: Healthy Skin Month—What Clinicians Should Watch in Skin Cancer Care

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

Quality of life gains came before disease activity responses with omalizumab in 

, according to post hoc analyses of the omalizumab-igec (Omlyclo; CT-P39) phase 3 trial Celltrion USA will present at the 

American College of Allergy, Asthma and Immunology (ACAAI) 2026 Annual Scientific Meeting

“The impact on quality of life can be substantial, with approximately 40% of patients with CSU scoring greater than 10 on the Dermatology Life Quality Index,” said Juby Jacob-Nara, MD, senior vice president and chief medical officer at Celltrion USA, in a statement.

 All 3 analyses will be presented as ePosters during Meet the Author sessions at the Phoenix Convention Center on November 14 and 15.¹

Additional analyses found comparable efficacy between CT-P39 and reference omalizumab (Xolair) regardless of baseline itch severity, and comparable pharmacokinetics in patients with comorbid asthma.¹ The data follow the October 5, 2026, US commercial launch of omalizumab-igec, which the FDA approved in March 2025 as interchangeable with reference omalizumab across all 4 of its indications.¹

 Approval was based on a double-blind, randomized, active-controlled phase 3 trial of 619 patients with CSU, which showed equivalent efficacy between CT-P39 and reference omalizumab on change in Weekly Itch Severity Score (ISS7) at week 12.

Omalizumab Disease Activity and Quality of Life in CSU

Metz and colleagues assessed patients with CSU receiving omalizumab 300 mg every 4 weeks for 24 weeks, followed by a 16-week off-treatment period.¹ Investigators sorted disease activity, measured by the Weekly Urticaria Activity Score (UAS7), and quality of life, measured by the Dermatology Life Quality Index (DLQI), into 5 previously established categories each to track how patients moved between categories across the study.¹ At baseline, the largest share of patients (36.7%) had severe disease and reported a very large effect of CSU on quality of life.¹

By week 12, 43.9% of patients were in the well-controlled or complete response UAS7 categories, and 72.5% reported no or small effect of CSU on quality of life.¹ At week 24, the end of treatment, 44.4% of patients achieved a complete response with no effect of CSU on quality of life.¹

At week 40, 16 weeks after the final dose, 41.7% of patients remained in the well-controlled or complete response categories with no or small effect on quality of life.¹ According to the investigators, quality of life improvements emerged earlier than disease activity improvements, and the week 40 data suggest persistent treatment effects up to 16 weeks after omalizumab discontinuation.¹

CT-P39 Efficacy by Itch Severity and Pharmacokinetics in Comorbid Asthma

A second analysis, from Zuberbier and colleagues, grouped 409 patients receiving CT-P39 or reference omalizumab 300 mg every 4 weeks by baseline ISS7: ISS7 ≥13 (n = 331) or ISS7 <13 (n = 78).¹ UAS7 and Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) scores declined at weeks 12, 24, and 40 regardless of baseline itch severity, with outcomes analyzed descriptively.¹ At week 24, mean UAS7 reductions were –24.8 with CT-P39 vs –26.3 with reference omalizumab in the ISS7 ≥13 group and –15.7 vs –16.0 in the ISS7 <13 group.¹

Pharmacokinetics With CT-P39 vs Reference Omalizumab

The third analysis, from Heffler and colleagues, evaluated pharmacokinetics and target engagement in 41 patients with physician-reported asthma at baseline who received CT-P39 or reference omalizumab 150 mg or 300 mg every 4 weeks.¹

At week 12, mean serum omalizumab concentrations were 26.9 vs 21.5 µg/mL with CT-P39 and reference omalizumab at 300 mg, and 15.2 vs 13.1 µg/mL at 150 mg.¹ Free immunoglobulin E (IgE) levels were 4.2 vs 2.7 ng/mL at 300 mg and 6.1 vs 2.9 ng/mL at 150 mg, respectively.¹ Investigators concluded CT-P39 demonstrated comparable pharmacokinetics and similar target engagement to reference omalizumab in this subgroup.¹

The ACAAI analyses did not report new safety data. Omalizumab-igec carries a boxed warning for anaphylaxis, and its label directs clinicians to start therapy in a healthcare setting and observe patients after administration.¹

Celltrion USA. Celltrion to present new analyses of OMLYCLO (omalizumab-igec) in chronic spontaneous urticaria at ACAAI 2026. Published November 12, 2026. Accessed November 12, 2026.

Celltrion USA. OMLYCLO (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR, now commercially available in the U.S. Published October 5, 2026. Accessed November 12, 2026. 

https://www.prnewswire.com/news-releases/omlyclo-omalizumab-igec-the-first-and-only-fda-approved-interchangeable-biosimilar-to-xolair-now-commercially-available-in-the-us-302898400.html

Saini SS, Maurer M, Dytyatkovska Y, et al. CT-P39 compared with reference omalizumab in chronic spontaneous urticaria: results from a double-blind, randomized, active-controlled, phase 3 study. 

Post hoc analyses of a phase 3 CSU program with omalizumab 300 mg q4w characterized trajectories of disease activity (UAS7) and quality of life (DLQI) across treatment and a 16-week off-therapy period. Baseline burden was high, with many patients reporting severe disease and marked DLQI impairment. By week 12, quality-of-life normalization outpaced disease-activity control, and by week 24 substantial complete responses were observed. A separate analysis suggested comparable outcomes for CT-P39 versus reference omalizumab irrespective of baseline itch severity, and pharmacokinetic/IgE target engagement appeared similar in patients with comorbid asthma.

Post hoc analyses at ACAAI 2026 show 41.7% of patients-maintained CSU control and quality of life 16 weeks after stopping omalizumab.

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.

Omalizumab Biosimilar CT-P39: Quality of Life Gains Precede CSU Control

Tatyana Kushner, MD, is an associate professor of medicine in the division of gastroenterology and hepatology at Weill Cornell Medicine.

AZURE-1 enrolled participants with cirrhosis, portal hypertension, and HIV, offering insight into how brelovitug may fit real-world hepatitis D care.

Hepatology

Weekly or Monthly? Fitting Brelovitug Into Hepatitis D Practice

Martina J. Porter, MD, is a dermatologist at Beth Israel Deaconess Medical Center.

Insurance and formulary disruptions force difficult interim choices for patients with HS. The panel also shares enthusiasm for emerging mechanisms and the prospect of matching therapies to disease phenotypes.

Video Series

HS Treatment Access Gaps and the Emerging Therapeutic Pipeline

Long-term trial and real-world experience suggest tunnel responses can be durable, and even regress in some patients. The panel describes how patient-defined success and follow-up cadence guide decisions to continue or escalate therapy.

HS Long-Term Outcomes: Durable Response, Tunnel Regression, and Monitoring

Late-breaking data presented at AASLD 2026 showed brelovitug met the phase 3 primary endpoint in chronic hepatitis D, with no treatment-related serious adverse events.

Brelovitug for Chronic Hepatitis D: Phase 3 AZURE-1 Results

Joseph Rossano, MD, MS, is the co-director of the Cardiac Center and chief of the division of cardiology at the Children’s Hospital of Philadelphia, as well as the Jennifer Terker Endowed Chair in Pediatric Cardiology.

Joseph Rossano, MD, MPH, discusses the 56-week active-treatment period of the SCOUT-HCM trial, which demonstrated the sustainability of mavacamten’s effects.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Stroke

On the HCPLive stroke page, resources on the topics of medical news and expert insight into CVA can be found. Content includes articles, interviews, videos, podcasts, and breaking news on stroke medicine, and more.

Cardiomyopathy

Mavacamten Sustainably Reduces LVOT Gradient in Pediatric oHCM Over 56 Weeks

Chari Cohen, DrPH, MPH, is the President of the Hepatitis B Foundation.

New survey data from 42 countries show high antiviral adherence among people with hepatitis B, but 64% of those untreated receive no hepatitis B care.

Hepatitis B

Hepatitis B page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis B virus research, treatment, and drug development.

Is HBV Really a Silent Disease? New Patient-Reported Data Suggests Otherwise

Pharmacovigilance data on 328 pregnancies exposed to glecaprevir/pibrentasvir presented at AASLD 2026 showed no vertical transmission and no pattern of congenital anomalies.

Hepatitis C

Hepatitis C page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis C virus research, treatment, and drug development.

Women's Health

On the HCPLive women's health page, resources on the topics of medical news and expert insight into obstetrics, gynecology, and women's related health can be found. Content includes articles, interviews, videos, podcasts, and breaking news on women's health, and more.

HCV Treatment in Pregnancy, With Tatyana Kushner, MD

Christie Ballantyne, MD, discusses his analysis of the CORALreef Lipids trial, highlighting enlicitide’s effects on LDL-C, ApoB, Lp(a), and non-HDL-C.

Dyslipidemia

Enlicitide Lowers LDL-C Consistently Across PREVENT CVD Risk Categories

Nancy Reau, MD, is Professor of Internal Medicine, Richard B. Capps Chair of Hepatology, Associate Director of Solid Organ Transplantation, and Section Chief of Hepatology at Rush University Medical Center.

Jasmohan Bajaj, MD, MS, joins Nancy Reau, MD, and Kimberly Brown, MD, on who to screen for HE in clinic and how to prepare patients and families.

Liver Lineup: Updates & Unfiltered Insights

Introducing Liver Lineup: Updates & Unfiltered Insights — an exciting new podcast delivering timely, candid perspectives on the most pressing topics in the fast-moving world of hepatology. Hosted by Nancy Reau, MD, and Kimberly Brown, MD, this series dives into the cutting edge of liver disease research, clinical care, and real-world practice.

Latest News

Diabetes Dialogue: Retatrutide Tops Semaglutide on A1C, Weight in T2D

Looking Beyond the Lungs in COPD Care, With Gerard Criner, MD

Diabetes Dialogue: CONNECT Trial Backs CGM in Non-Insulin Type 2 Diabetes

Q&A: Healthy Skin Month—What Clinicians Should Watch in Skin Cancer Care

Omalizumab Biosimilar CT-P39: Quality of Life Gains Precede CSU Control