Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

Vanda Pharmaceuticals Inc. has announced its filing of a Biologics License Application (BLA) with the 

 seeking approval of imsidolimab for the treatment of 

GPP is an uncommon but severe autoinflammatory skin disease. The condition can be life-threatening and is characterized by abrupt episodes of significant skin redness, widespread sterile pustules, and systemic manifestations including fever and profound fatigue. GPP is largely linked to loss-of-function mutations in the interleukin (IL)-36RN gene, resulting in the impaired regulation of the IL-36 inflammatory pathway.

"The submission of the BLA for imsidolimab marks a critical milestone in our efforts to bring this innovative therapy to patients suffering from GPP," said Mihael H. Polymeropoulos, MD, president, CEO, and Chairman of the Board of Vanda Pharmaceuticals, said in a statement.

GPP was described in Vanda's release as an area of notable unmet medical need, with its reported rate of prevalence varying significantly across geographic areas.

 The disease's estimates ranging from roughly 2 to as high as 124 cases per million people around the world, with diminished rates generally observed in Europe and increased rates seen in regions of Asia.

The GPP drug itself, imsidolimab, is a fully human IgG4 antibody designed to suppress IL-36 receptor signaling, thereby compensating for the decreased activity of the endogenous IL-36 receptor antagonist that is commonly noted in individuals living with GPP due to IL36RN mutations. Development of this medication is being done specifically for this rare orphan indication.

Data on the efficacy of this medication which support the BLA come from the phase 3 GEMINI-1 trial. In this study, 45 patients were recruited for evaluation who were randomized in a 1:1:1 ratio to be treated with a single intravenous dose of 750 mg imsidolimab, 300 mg imsidolimab, or placebo on Day 0. By the 4-week mark, serving the investigators as the primary endpoint, 53% of patients treated with imsidolimab at either dose attained a Generalized Pustular Psoriasis Physician Global Assessment score of 0 or 1, suggesting clear or almost clear skin.

This was compared to only 13% of individuals included in the placebo cohort of the study. For those in the 750 mg dose group, the difference was statistically significant, with a 

-value of .0131. Those who responded to treatment in GEMINI-1 were subsequently placed into the GEMINI-2 analysis, during which they were re-randomized to receive subcutaneous maintenance therapy each month with 200 mg imsidolimab or placebo. They were followed for as long as 116 weeks.

During the GEMINI-2 maintenance phase, all patients being given active imsidolimab maintained clear or nearly clear skin without reports of any GPP  flares.

 Meanwhile, only 25% of those included in the placebo maintenance arm maintained response, and 63% experienced flares. Across both GEMINI analyses, imsidolimab was shown to have been generally well tolerated. The investigators did not identify any treatment-related serious adverse events reported and no discontinuations resulting from occurrence of adverse events.

Overall, the BLA submission is supported by consistent findings from the global GEMINI-1 and GEMINI-2 phase 3 studies, demonstrating that a single intravenous dose of imsidolimab may result in rapidly controlled disease activity among those with GPP. Additionally, the trials suggest clinical benefit can be sustained for nearly 2 years with monthly maintenance dosing.

Vanda has also requested priority review of the application, noting the serious nature of GPP and the lack of adequate therapies available for this rare orphan disease. Provided the FDA grants priority review, the agency would aim to complete its assessment within 6 months. This could allow for a potential approval of imsidolimab for GPP as early as mid-2026.

"Imsidolimab builds on our growing expertise in rare orphan disorders and our anti-inflammatory portfolio, including Ponvory®, which is approved for the treatment of relapsing forms of multiple sclerosis and is in clinical development for the treatment of psoriasis and ulcerative colitis," Polymeropoulos said in a statement.

 "We look forward to potential FDA approval and leveraging our commercial infrastructure to address this debilitating condition."

Vanda Announces Submission of Biologics License Application to the FDA for Imsidolimab for the Treatment of Generalized Pustular Psoriasis. Vanda Pharmaceuticals, Inc. December 15, 2025. 

https://www.prnewswire.com/news-releases/vanda-announces-submission-of-biologics-license-application-to-the-fda-for-imsidolimab-for-the-treatment-of-generalized-pustular-psoriasis-302641858.html

Sachen KL, Arnold Greving CN, Towne JE. Role of IL-36 cytokines in psoriasis and other inflammatory skin conditions. Cytokine 156, 155897 (2022).

Prinz JC, et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. Journal of the European Academy of Dermatology and Venereology 37, 256–273 (2022).

Articles

Vanda Pharmaceuticals has filed a Biologics License Application with the FDA for imsidolimab, targeting generalized pustular psoriasis (GPP), a severe autoinflammatory skin disease. GPP is linked to IL-36RN gene mutations, leading to impaired IL-36 pathway regulation. Imsidolimab, a fully human IgG4 antibody, suppresses IL-36 receptor signaling. Phase 3 GEMINI trials showed significant efficacy, with 53% achieving clear skin compared to 13% on placebo. The drug was well-tolerated, with no serious adverse events. Vanda seeks priority review, potentially leading to approval by mid-2026.

Vanda Pharmaceuticals submitted a BLA to the FDA for imsidolimab, a novel IgG4 IL-36 receptor antagonist, to treat generalized pustular psoriasis (GPP).

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.

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.

News

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Clinical

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Imsidolimab’s Biologics License Application for Treatment of GPP Submitted to FDA 

Abigail Brooks is an assistant managing 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.

The US Food and Drug Administration has granted Breakthrough Device Designation to Nephrodite’s Holly™ implantable, continuous dialysis system.

Announced on December 15, 2025, the designation recognizes Holly as a novel, transformative therapy addressing end-stage kidney disease (ESKD), for which current treatment options include hemodialysis and peritoneal dialysis. Both approaches notably limit mobility and patients’ quality of life, with no adequately effective alternatives available to patients since the advent of hemodialysis > 70 years ago.

“Dialysis sustains life, but at tremendous cost to a patient’s freedom and physiology,” Hiep Nguyen, MD, co-founder and SVP of Science and Technology at Nephrodite, said in a statement.

 “Holly represents a complete rethinking of kidney replacement, with a continuously functioning implant capable of matching the body’s natural rhythm. It’s both a scientific milestone and a human one.”

As described by Nephrodite, the first-of-its-kind implantable platform is engineered to function continuously inside the body, replacing natural kidney function. The proprietary platform combines advanced hemofiltration technology with biocompatible materials optimized for long-term implantation and physiologic performance. It is designed to continuously filter waste, balance fluids, and manage electrolytes without the need for frequent clinic visits required by traditional, center-based dialysis.

The Holly system integrates intelligent sensors, machine learning algorithms, and secure remote monitoring for physician oversight and individualized therapy. The internal implant is being designed to link through a simple external interface to a small, portable home unit used nightly for dialysis support.

Holly’s Breakthrough Device Designation was supported by data from Nephrodite’s multi-day large animal study demonstrating sustained kidney function replacement with strong safety and performance outcomes. On December 9, 2025, the Company announced successful results from this study showing what is believed to be the first demonstration of sustained, continuous kidney function replacement by a fully mechanical implantable device in a living sheep, without the complications typically associated with current dialysis technologies.​​ The 72-hour study was performed at the Conrad Jobst Vascular Research Laboratories at the University of Michigan.

The designation allows the Company to benefit from expedited review and enhanced FDA guidance.

“I’m proud of our stellar team for earning this extraordinary recognition. The designation reinforces the scientific and clinical significance of what we’re building,” said Nikhil Shah, DO, MPH, co-founder and CEO of Nephrodite.

 “Holly was designed from the ground up to free patients from the cycle of center-based dialysis. Breakthrough status enables close collaboration with regulators and accelerates our path toward first-in-human studies.”

As described in the December 15, 2025, release, building on the Breakthrough Device designation and the preclinical animal study findings, Nephrodite is preparing for Good Laboratory Practice (GLP) studies and subsequent regulatory submissions to enable first-in-human clinical trials.

Nephrodite. Nephrodite Earns FDA’s First Breakthrough Device Designation for an Implantable Kidney Replacement System. December 15, 2025. Accessed December 15, 2025. 

https://www.businesswire.com/news/home/20251215001657/en/Nephrodite-Earns-FDAs-First-Breakthrough-Device-Designation-for-an-Implantable-Kidney-Replacement-System

Nephrodite. Nephrodite Announces Industry’s First Successful Multi-Day Large Animal Study for a Fully Implantable Renal Replacement Device. December 9, 2025. Accessed December 15, 2025. 

https://nephrodite.com/newsroom/nephrodite-announces-industrys-first-successful-multi-day-large-animal/

The FDA has granted Breakthrough Device Designation to Nephrodite's Holly™, an implantable continuous dialysis system for end-stage kidney disease (ESKD). Holly offers a novel approach to kidney replacement, functioning continuously inside the body and improving patient mobility and quality of life compared to traditional dialysis. The system integrates advanced technology, including intelligent sensors and machine learning, for personalized therapy. Supported by successful large animal studies, the designation facilitates expedited FDA review and guidance, paving the way for future human clinical trials and potential transformation in ESKD treatment.

The Holly system is a first-of-its-kind implantable, continuous dialysis system designed to give patients freedom from the cycle of center-based dialysis.

Nephrology

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

Chronic Kidney Disease

FDA News

FDA Grants Breakthrough Device Designation to Holly Implantable Dialysis System

Darren Brenner, MD, is a professor of medicine and surgery in the division of gastroenterology at Northwestern University and serves as director of the Neurogastromotility and Interdisciplinary Bowel Dysfunction programs.

Real-World Data Highlight a New Approach to Chronic Constipation, With Darren Brenner, MD

Chronic idiopathic constipation (CIC) remains one of the most challenging and heterogenous disorders encountered in GI practice. While clinicians today have a wide therapeutic armamentarium, including osmotic and stimulant laxatives, secretagogues, and prokinetic agents, each option carries limitations and side effects that impede adherence and patient satisfaction.

Against this backdrop, the vibrating capsule (Vibrant System) represents a novel, device-based therapeutic approach designed to enhance colonic motility without pharmacologic action. New real-world evidence published adds meaningful long-term data showing patients using the device for 3 and 6 months experienced improvements across multiple clinically relevant endpoints, including increased complete spontaneous bowel movements, reduced straining, and greater frequency of complete evacuation.

“Vibrant has a couple of different benefits. Number one, we know that it works,” Darren Brenner, MD, a professor of medicine and surgery in the division of gastroenterology at Northwestern University and serves as director of the Neurogastromotility and Interdisciplinary Bowel Dysfunction programs, told 

. “We now have multiple data points showing that this can be effective, from the phase 3 trials that show that it could significantly improve one to two complete spontaneous bowel moments a week in patients to now our data showing that 3 to 6 months later, people are doing very well for multiple endpoints.”

The postmarketing analysis included 491 and 298 patients who completed 3 and 6 months of treatment, respectively. Significant improvements in the average number of CSBMs/week were observed for these patients from baseline (3 months: 2.37; 6 months 2.51; average across entire treatment duration; 

 >.0001). Mean stool consistency also improved from 3.4 at baseline to 4.1 during treatment (average across entire treatment duration; 

 <.0001), as did straining effort, which decreased from a mean score of 2.9 at baseline to 1.6 during treatment (average across entire treatment duration; 

Of note, abdominal pain, bloating, and nausea were each reported by <2% and diarrhea by <1% of the patient population.

“For my patients, when I discuss different therapeutic options, from their perspective, that's a real selling point, the lack of diarrhea and that concern about the urgency associated with having to go to the bathroom,” Brenner said.

The vibrating capsule system includes a downloadable electronic stool diary app for patient use, and each patient is encouraged to record their daily bowel patterns in this e-diary. The system also includes a pod that registers and activates each of the capsules before its ingestion, thereby providing a record of the patient's adherence to therapy.

“This app based program keeps people astute to the fact that they're using a therapy which may increase compliance,” Brenner said. “I've always told my patients, if you don't take the medication or the therapeutic, it's not going to do anything. Nothing is going to change… so this is kind of a reminder. People get a sense that this is working. When they’re looking through their data, they really see a benefit compared to where they were before.”

Vibrant. New Real-World Evidence Study Demonstrates Vibrant System’s Continuous Effectiveness and Exceptional Tolerability for Chronic Idiopathic Constipation. November 6, 2025. Accessed December 12, 2025. 

https://www.globenewswire.com/news-release/2025/11/06/3182653/0/en/New-Real-World-Evidence-Study-Demonstrates-Vibrant-System-s-Continuous-Effectiveness-and-Exceptional-Tolerability-for-Chronic-Idiopathic-Constipation.html

Brenner DM, Rao SSC, Curtin B, Quigley E. Real-World Evidence of the Long-Term Clinical Utility of a Vibrating Capsule in the Management of Chronic Idiopathic Constipation. Clinical and Translational Gastroenterology. 

Videos

Brenner describes shortcomings of pharmacologic CIC options and reviews real-world data on the Vibrant System’s benefits in this context.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

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.

Image Credit: US Food and Drug Administration

Announced by parent company LIB Therapeutics on December 15, 2025, the 

 has approved lerodalcibep-liga (Lerochol) injection for subcutaneous use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

“The primary challenge in lipid management today is helping patients achieve and maintain the increasingly stringent LDL-C targets in current guidelines,”  Dean Kereiakes, MD, chairman of The Christ Hospital Heart and Vascular Institute and professor of Medicine at the University of Cincinnati, said in a statement.

 “While PCSK9 inhibitors as a class deliver powerful cholesterol lowering potential, LEROCHOL was designed to address the barriers that have limited their use, including ease of use features like a single small monthly injection, self-administered at home with extended room-temperature stability for home storage and travel. For patients with cardiovascular disease who require lifelong cholesterol management, LEROCHOL offers an important addition to our treatment options.”

Lerodalcibep is a novel, small protein-binding, third-generation PCSK9 inhibitor in development as a once-monthly, single small-volume subcutaneous injection for LDL-C lowering. Its anti-PCSK9 binding domain is adnectin, an 11-kDa polypeptide designed for high-affinity subanomolar binding to human PCSK9 and fused to human serum albumin to increase plasma half-life. Additionally, lerodalcibep does not require refrigeration, separating it from all approved PCSK9 inhibitors.

The FDA’s decision was based on results from the LIBerate program, a series of 5 global phase 3 registration studies including 2900 patients. Most recently, the LIBerate-HoFH phase 3 trial, published in January 2025, compared lerodalcibep to evolocumab for the treatment of 

homozygous familial hypercholesterolemia (HoFH)

. The study consisted of 2 24-week treatment periods separated by an 8-week washout, conducted in 12 lipid clinics in 6 countries.

Patients were aged ≥10 years and had genetically confirmed HoFH. Included patients were randomly assigned to either lerodalcibep 300 mg monthly or evolocumab 420 mg monthly for 24 weeks (period A), followed by an 8-week washout before being swapped to the alternate treatment for the next 24 weeks (period B). The primary efficacy endpoint was the percent change from baseline in LDL cholesterol concentration to week 24 for both period A and B. The intent-to-treat (ITT) population consisted of all randomly assigned patients, and the safety population included all patients who received any study medication.

Ultimately, 82 patients were screened, and 6 entered period A. Mean age was 28.7 years (standard deviation [SD], 15.2), and 20 of 66 were pediatric patients. Mean baseline LDL cholesterol was 10.59 mmol/L (SD, 4.37). By week 24, mean LDL cholesterol reduction by ITT analysis was -4.9% on lerodalcibep compared to -10.3% on evolocumab, with a mean difference between treatments of 5.4% (95% CI, -0.2 to 11.1).

When averaged across all monthly visits, LDL cholesterol response was -9.1% on lerodalcibep and -10.8% on evolocumab. Both drugs were well tolerated and exhibited no treatment-related serious adverse events. Injection site reactions were reported in 1 of 66 patients on lerodalcibep and 15 of 62 on evolocumab. Investigators determined that these results indicate lerodalcibep’s noninferiority to evolocumab.

“[Lerodalcibep-liga] was designed for patients who need life-long treatment to achieve and maintain the new lower LDL-C goals especially those with cardiovascular disease and the millions with inherited high cholesterol (familial hypercholesterolemia or FH). We look forward to bringing [lerodalcibep-liga] to patients in the coming months," Evan Stein, MD, PhD, Founder, CEO and Chief Scientific Officer of LIB Therapeutics, said in a statement.

LIB Therapeutics. U.S. Food and Drug Administration Approves LIB Therapeutics’ LEROCHOL

 (lerodalcibep-liga) for Adults with Elevated LDL Cholesterol. December 15, 2025. Accessed December 15, 2025. 

https://www.businesswire.com/news/home/20251215907781/en/U.S.-Food-and-Drug-Administration-Approves-LIB-Therapeutics-LEROCHOL-lerodalcibep-liga-for-Adults-with-Elevated-LDL-Cholesterol

Choong I. LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population. 

. February 10, 2025. Accessed December 9, 2025. 

https://www.businesswire.com/news/home/20250210806330/en/LIB-Therapeutics-Announces-FDA-Acceptance-of-Biologics-License-Application-for-Lerodalcibep-to-Lower-LDL-Cholesterol-Across-Broad-Patient-Population

Raal FJ, Mehta V, Kayikcioglu M, et al. Lerodalcibep and evolocumab for the treatment of homozygous familial hypercholesterolaemia with PCSK9 inhibition (LIBerate-HoFH): a phase 3, randomised, open-label, crossover, non-inferiority trial. Lancet Diabetes Endocrinol. 2025;13(3):178-187. 

The FDA has approved lerodalcibep-liga (Lerochol) for subcutaneous use to lower LDL-C in adults with hypercholesterolemia, including HeFH. This third-generation PCSK9 inhibitor offers a convenient once-monthly injection without refrigeration, addressing barriers to PCSK9 inhibitor use. The approval was based on the LIBerate program, which demonstrated lerodalcibep's noninferiority to evolocumab in reducing LDL-C in HoFH patients. The drug was well-tolerated, with minimal adverse events, and is designed for lifelong cholesterol management, particularly in patients with cardiovascular disease and familial hypercholesterolemia.

FDA approves lerodalcibep, a groundbreaking PCSK9 inhibitor, offering a monthly injection for LDL cholesterol reduction in patients with HoFH.

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...

Dyslipidemia

FDA Approves Lerodalcibep-liga (Lerochol) for LDL-C Reduction in Hypercholesterolemia

New research is shedding light on the feasibility and safety of intentional weight loss with a low-energy total diet replacement before colorectal cancer surgery in patients with colorectal cancer and excess weight.1

Findings from the multicenter, external, feasibility, parallel, individually randomized CARE trial show a low-energy total diet replacement before colorectal cancer resection is feasible and well tolerated, lacks safety concerns, and is likely cost-effective.

According to the World Health Organization, colorectal cancer is the third most common cancer worldwide, accounting for approximately 10% of all cancer cases and is the second leading cause of cancer-related deaths worldwide. Surgical resection is part of the standard treatment for most patients but carries a higher risk of postoperative morbidity than many other major abdominal operations. This risk can be further heightened by excess weight.

“In bariatric surgery, preoperative weight loss is associated with better outcomes. However, the short interval between diagnosis and treatment in colorectal cancer necessitates an intensive weight loss intervention,” Dimitrios Koutoukidis, PhD, an associate professor on Diet and Obesity at University of Oxford, and colleagues wrote.

 “It is unclear whether people with cancer will enroll in and adhere to such a program during this unsettling period. There is little evidence from clinical trials on the benefits and risks of substantial intentional weight loss in this setting.”

To address this gap in research, investigators conducted an assessor-blinded randomized clinical trial performed between March 2023 and August 2024 with a 30-day postoperative follow-up in adults with a body mass index ≥ 28 who were awaiting curative elective colorectal cancer resection at 8 hospitals across England. Participants were randomly assigned in a 1:1 ratio to either a low-energy total diet replacement program or standard care.

In addition to their local standard care pathway, participants in the intervention group were asked to replace all their foods with 4 nutritionally complete meal replacement products per day until their surgery. These meals provided approximately 800 kcal/d, including 76 g/d of protein with the nutritional composition aligned with regulatory requirements. Participants had a 45-minute introductory telephone consultation with a dietitian, weekly 20-minute follow-up calls, and a 10-minute exit call. Participants in the control group followed their local standard care pathway.

Investigators outlined 5 predefined feasibility aspects to assess progression to a definitive trial: recruitment of ≥ 72 patients, engagement with ≥75% of dietetic telephone calls attended, adherence (≥60% of intervention participants achieving ≥5% weight loss), and ≥ 85% retention. Secondary outcomes included morbidity, symptoms, and changes in weight and fat-free mass. Outcomes were modeled during a 30-year time horizon using cohort simulation.

Of the 150 potentially eligible participants approached, 71 eligible randomized participants undergoing surgery (n = 36 in the intervention group and n = 35 in the usual care group) were included in the analysis. Among the cohort, the mean age was 64 (standard deviation [SD], 8.7) years, 61% of patients were male, and the mean body mass index was 35.4 (SD, 5.4).

Investigators noted participants were accrued at a rate of 0.57 participants per site per month compared with the anticipated rate of 0.75. Participants attended 85% of their dietetic calls.

The median period from randomization to surgery was 33 (interquartile range, 25 to 43) days, during which 22 (61%) of the intervention participants and 3 (9%) of the usual care participants lost ≥ 5% of their weight (odds ratio, 16.8; 95% CI, 4.3 to 65.3). Results showed intervention participants lost a mean of 6.1 (SD, 3.0) kg before surgery, which was 4.3 kg (95% CI, 2.7 to 5.8 kg) more than the usual care participants. Further analysis revealed the between-group adjusted change in fat-free mass was 0.1 kg (95% CI, −3.9 to 4.0 kg).

Investigators did not observe any difference between the 2 groups regarding the proportion of patients with any complications (39% vs 40%) or with Clavien-Dindo grade I, II, or III complications. Of note, fecal incontinence (−8.6 points; 95% CI, −16.7 to −0.5 points) and sore skin (−15.9 points; 95% CI, −25.3 to −6.6 points) improved postoperatively in the intervention compared with usual care group, and there were no intervention-related serious adverse events.

Retention was 100%, exceeding the 85% goal. In an exploratory observational analysis, participants who lost ≥ 3.2% of their body weight had a 50% relative reduction in complications (95% CI, 1% to 78%).

The incremental cost-effectiveness ratio was estimated to be £7623, or $10,193.40 USD, per quality-adjusted life-year, and the probability that the intervention would be cost-effective at the conventional willingness-to-pay threshold of £20,000, or $26,742.08 USD, was 61%.

“An intensive preoperative weight loss intervention was safe, feasible, and likely cost-effective as part of prehabilitation before colorectal cancer surgery with evidence of improvements in key symptoms,” investigators concluded.

 “Some challenges to recruitment need to be addressed before a definitive trial assesses perioperative and longer-term outcomes.”

Koutoukidis DA, Jebb SA, Reynolds S, et al. Preoperative Weight Loss in Patients With Excess Weight and Colorectal Cancer: The CARE Feasibility Randomized Clinical Trial. 

 2025;8(12):e2547126. doi:10.1001/jamanetworkopen.2025.47126

World Health Organization. Colorectal cancer. July 11, 2023. Accessed December 12, 2025. 

https://www.who.int/news-room/fact-sheets/detail/colorectal-cancer

Research indicates that a low-energy total diet replacement before colorectal cancer surgery is feasible, safe, and potentially cost-effective for patients with excess weight. The CARE trial demonstrated that this intervention is well-tolerated and may improve surgical outcomes by reducing postoperative complications. Participants in the intervention group achieved significant weight loss compared to standard care, with no increase in adverse events. The study suggests that preoperative weight loss could be a valuable component of prehabilitation, although recruitment challenges must be addressed for future trials.

Findings from the CARE feasibility RCT show the safety, feasibility, and likely cost-effectiveness of intentional weight loss before colorectal cancer surgery.

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

Intensive Weight Loss Before Colorectal Cancer Surgery Safe, Feasible

The approval makes inebilizumab-cdon the first and only CD19-targeted B cell therapy indicated for anti-AChR and anti-MuSK Ab+ generalized myasthenia gravis.

Neurology

Neurology condition center page is a comprehensive resource for clinical news and insights on nervous system disorders. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for Alzheimer's disease, brain injury, PTSD, and more.

FDA Approves Inebilizumab-cdon (Uplizna) for Generalized Myasthenia Gravis

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. 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.

Berotralstat (ORLADEYO) oral granules become the first FDA-approved therapy specifically designed to prevent HAE attacks in children aged 2 – 11 years.

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.

FDA Approves Oral Berotralstat for Children Aged 2 – 11 Years with HAE  

The approval of a dye- and preservative-free powder formulation of trofinetide offers a new option for adult and pediatric patients with Rett syndrome.

FDA Approves New Powder Formulation of Trofinetide (Daybue) for Rett Syndrome

The phase 3 DISCREET study explored the safety and efficacy of apremilast in treating patients with moderate to severe genital psoriasis over 32 weeks.

Apremilast Effective Treatment for Moderate to Severe Genital Psoriasis at 32 Weeks

2025 data show the US is still failing to adequately identify and initiate care for deadly lung disease. Experts discuss what it will take to turn the tide on this public health issue.

This Year In Medicine

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.

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.

Lung Cancer

Getting Through the Door: How COPD, Lung Cancer Screening Remains Minimal

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

Weight-adjusted waist index outperforms obesity indices for cardiovascular disease prediction in cardiovascular-kidney-metabolic syndrome 


Weight-Adjusted Waist Index Can Predict CVD Risk in Cardiovascular Kidney Metabolic Syndrome


What are your impressions of the Phase 2b data of zasocitinib in psoriasis, particularly in terms of Psoriasis Area and Severity Index (PASI) responses, dose-dependent effects, and tolerability? How do you see these results influencing your real-world patient selection?

Efficacy and Safety of Zasocitinib in Psoriasis and the Ideal Candidates for TYK2 Inhibitors

The panel reviews the HELIOS-B Phase 3 trial evaluating vutrisiran, a transthyretin silencer, in patients with ATTR-CM. Participants were randomized to receive vutrisiran or placebo, with approximately 40% already taking tafamidis at trial entry, particularly in the United States. The study was designed with predefined primary and secondary endpoints, assessing outcomes both in the overall population and in those not on baseline tafamidis. The trial demonstrated statistically significant results across all major endpoints, including reductions in all-cause mortality and cardiovascular hospitalizations, with notable benefit observed both in monotherapy and combination-therapy subgroups.
The panel highlights the magnitude of treatment effect and notes that these findings supported FDA approval of vutrisiran for ATTR-CM. They also emphasize its favorable safety profile, explaining that common adverse events—such as cardiac failure and arrhythmias—reflect the underlying disease rather than the drug itself. Overall, the experts describe vutrisiran as a meaningful and well-tolerated therapeutic advancement for patients with ATTR-CM.


Video Series

Evaluating Efficacy and Safety of Vutrisiran in ATTR-CM from the HELIOS-B Trial

The panelists review EADV 2025 data evaluating whether bimekizumab may help prevent PsA development in patients with psoriasis only. The study followed psoriasis patients prospectively and stratified risk using clinical factors and a patient questionnaire (PASE), treating scores <47 as low risk and ≥47 as high risk. Among patients with >1 risk factor treated with bimekizumab, over 96% maintained PASE scores <47 on longitudinal follow-up—used here as a patient-reported surrogate for not developing PsA symptoms (noting the limitation of no comparator arm). These findings align with real-world practice that prioritizes identifying high-risk patients and monitoring symptom trajectories over time. Overall, the experts interpret the stratified results as supportive—though preliminary—evidence that sustained IL-17A/F blockade may reduce transition to PsA in higher-risk psoriasis populations, while emphasizing the need for prospective, comparative data.

Bimekizumab in Psoriasis: EADV 2025 Insights and Approaches to Patient Monitoring

The panel discusses the concept of achieving a rapid reduction, or “knockdown,” of transthyretin (TTR) production in ATTR-CM. They note that the rationale is intuitive: slowing or halting new amyloid formation as early as possible may help interrupt disease progression. The comparison is made to AL amyloidosis, where shutting down the source of the abnormal protein is central to treatment. However, the panel emphasizes that ATTR-CM develops gradually over many years, and as a result, even when TTR production is reduced, clinical improvement is typically gradual rather than immediate.
The experts highlight the importance of setting realistic patient expectations—treatment reduces ongoing injury but does not rapidly remove existing amyloid deposits. They also discuss the need to understand which symptoms are truly amyloid-related versus coincidental, and they stress the long-term, supportive relationships clinicians build with patients and families, particularly when helping individuals adjust goals and maintain quality of life over time.


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