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.

Chronic kidney disease (CKD) affects an estimated 35 million people in the United States, yet it remains persistently underdiagnosed, underrecognized, and often addressed late in its course.

Despite a wave of therapeutic innovation over the past decade, including SGLT2 inhibitors, non-steroidal mineralocorticoid receptor antagonists, and GLP-1 receptor agonists, most patients continue to enter care at stage 3b or later, when significant and often irreversible kidney damage has already occurred. Against this backdrop, a recent multidisciplinary virtual forum from 

, led by Muthiah Vaduganathan, MD, MPH, codirector of the Center for Cardiometabolic Implementation Science at Brigham and Women’s Hospital, convened nephrologists from academic and private practice settings across the country to examine a central question: how do we move CKD detection and management upstream?

The discussion centered on operationalizing early identification of CKD using routine biomarkers such as estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR), and on improving risk stratification before patients ever see a nephrologist. Participants highlighted national data showing persistent gaps in CKD awareness, particularly among younger individuals, women, and racial and ethnic minority populations.

Even among patients with documented CKD in the medical record, awareness remains low. Compounding the problem is a limited nephrology workforce, making universal early referral neither feasible nor necessary.

Instead, the conversation emphasized redefining early CKD as a cardiovascular risk condition and embedding screening within broader cardio-kidney-metabolic care. With cardiovascular disease remaining the leading cause of death in CKD, panelists argued that early kidney abnormalities, especially albuminuria, should be framed not simply as markers of future dialysis risk, but as powerful indicators of systemic vascular injury.

In an era of disease-modifying therapies capable of slowing progression and reducing cardiovascular events, the forum explored how clinicians, health systems, and payers might rethink detection strategies, referral pathways, and multidisciplinary collaboration.

Throughout the discussion, participants repeatedly returned to the reality that most referrals still occur when eGFR falls < 45 mL/min/1.73 m², while earlier-stage patients, particularly those with preserved eGFR but significant albuminuria, are often missed. UACR testing remains underutilized outside of diabetes care, and confusion persists among primary care clinicians regarding the interpretation of albuminuria versus total proteinuria.

Several panelists described educational initiatives aimed at improving primary care understanding, including reframing albuminuria as the “troponin of the kidney,” yet acknowledged that education alone may not be sufficient. Workforce shortages, time constraints in 20-minute visits, EHR fatigue, and limited health literacy all create structural barriers to earlier detection and intervention.

Ultimately, the forum highlighted a need for system-level change. Potential solutions discussed included risk-based referral models rather than rigid eGFR thresholds, automated EHR or AI-driven lab triggers, payer-aligned quality metrics tied to UACR screening, and community-based outreach in high-risk populations.

The broader shift toward a cardio-kidney-metabolic framework was seen as an opportunity to align specialties around shared therapies and shared risk reduction goals. However, panelists were candid: without stronger incentives, clearer risk stratification tools, and expanded workforce capacity, the promise of early CKD “remission” through modern therapies may remain unrealized.

US Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2023. May 15, 2024. Accessed February 11, 2026.

Articles

Experts discuss shifting CKD detection upstream, improving albuminuria screening, and enabling earlier, risk-based intervention.

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Chronic Kidney Disease

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Rethinking Early Detection of CKD: A Shift Toward Upstream Care

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.

 issued a Complete Response Letter for the New Drug Application (NDA) of Disc Medicine’s bitopertin as a treatment for patients with 

The Agency acknowledges sufficient evidence of reduced whole blood metal-free protoporphyrin IX (PPIX) from the AURORA and BEACON trials, but stated a need to see results of the ongoing phase 3 APOLLO study before bitopertin receives approval.

EPP is a rare, inherited metabolic disorder marked by severe, immediate, and painful photosensitivity, often beginning in childhood. In this patient population, a deficiency in the ferrochelatase enzyme results in protoporphyrin buildup, which is indicated by intense burning, itching, and swelling upon exposure to sunlight.

Bitopertin is an investigational, clinical-stage, orally administered glycine transporter 1 (GlyT1) inhibitor, designed to modulate heme biosynthesis. GlyT1 is a membrane transporter required to supply sufficient glycine for heme biosynthesis and support erythropoiesis. If approved for EPP, bitopertrin has the potential to be the first disease-modifying therapy.

“We are committed to delivering bitopertin to patients, knowing how critical this potentially disease-modifying therapy is to the EPP community. While our efforts at utilizing expedited pathways to get bitopertin to patients quickly have not come to fruition, we are continuing to pursue all avenues in support of FDA approval,” said John Quisel, JD, PhD, President and Chief Executive Officer of Disc Medicine, in a statement. “The CRL will delay the potential approval of bitopertin, but we have confidence in the ongoing APOLLO trial, for which we are seeing incredible enthusiasm from the EPP community. Confidence in our product and program guides our approach, and we will continue working closely with the FDA to support their review.”

Bitopertis has been under review for accelerated approval and as part of the Commissioner’s National Priority Voucher pilot program, with accelerated approval contingent on the proposed surrogate endpoint, percent change in whole blood metal-free PPIX, and whether this was reasonably likely to predict a clinical benefit.

While the FDA agreed that phase 2 double-blind, placebo-controlled AURORA and phase 2 open-label BEACON met the proposed surrogate endpoint, neither showed evidence of an association between percent change in PPIX and sunlight exposure-based endpoints. In turn, the Agency indicated the phase 3 APOLLO results would be needed as evidence for traditional approval.

APOLLO is a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of bitopertin in participants with EPP or X-Linked protoporphyria (XLP). Currently, the estimated enrollment size includes 150 participants ≥ 12 years of age.

Specifically, APOLLO investigators are assessing whether bitopertin increases pain-free sunlight exposure after 6 months of treatment and how PPIX concentration levels change from baseline.

The trial began enrollment in March 2025, and has an estimated completion timeline of October 2026.

Disc Medicine Inc. Disc Medicine Receives Complete Response Letter from FDA for Bitopertin for the Treatment of EPP. GlobeNewswire News Room. Published February 13, 2026. Accessed February 13, 2026. 

https://www.globenewswire.com/news-release/2026/02/13/3238299/0/en/Disc-Medicine-Receives-Complete-Response-Letter-from-FDA-for-Bitopertin-for-the-Treatment-of-EPP.html

Clinicaltrials.gov. Published 2026. Accessed February 13, 2026. 

https://clinicaltrials.gov/study/NCT06910358

The FDA denied accelerated approval for bitopertin, citing a need for evidence on clinical benefit from the ongoing phase 3 APOLLO trial. 


RDR Alert®

The Rare Disease Report page is a resource for medical news and expert insights on rare diseases. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for sickle cell disease, multiple myeloma, and more.

FDA News

FDA Issues Complete Response Letter to Bitopertin For Erythropoietic Protoporphyria

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!

Diabetes Dialogue: Oral Ozempic and the Risks of Compounding Formulas

In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, explore major updates in the evolving GLP-1 receptor agonist landscape, with a particular focus on oral semaglutide formulations, branding changes, and regulatory concerns surrounding compounded alternatives.

00:05:33 The importance of administration

00:06:56 Compounding drugs - the Hims and Hers drama

00:07:56 The danger of unregulated compound drugs

The discussion begins with the FDA approval of a higher-dose oral semaglutide formulation now branded as Ozempic for type 2 diabetes. Previously marketed as Rybelsus, the formulation itself remains bioequivalent, with no changes in efficacy, safety, or pharmacokinetics. The rebranding aligns oral and injectable Ozempic, simplifying clinical conversations and reducing prior authorization and coverage confusion. Similarly, oral Wegovy is now available for obesity management, reinforcing a unified naming convention: Ozempic for type 2 diabetes and Wegovy for obesity, regardless of route of administration.

The hosts note that while oral semaglutide has been available for several years, uptake of Rybelsus lagged behind expectations, in part due to limited brand recognition and confusion about its equivalence to injectable semaglutide. Early anecdotal experience suggests greater patient interest in “oral Ozempic,” highlighting the impact of naming clarity on real-world adoption. The simplified dosing structure of the newer formulations may further facilitate transitions during the upcoming rollout period.

Importantly, Isaacs and Bellini review key pharmacologic considerations. Oral semaglutide depends on the absorption enhancer SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) to protect the peptide from gastric degradation and promote systemic uptake. Administration remains strict: taken on an empty stomach with no more than 4 ounces of water, followed by a 30-minute interval before food, beverages, or other medications. Despite daily dosing, the drug retains a long half-life of approximately one week, meaning that temporary discontinuation—for example, prior to planned pregnancy—requires appropriate lead time. They emphasize that daily administration reflects absorption variability rather than a shorter pharmacologic duration.

The episode then pivots to safety concerns surrounding compounded oral semaglutide products. With GLP-1 shortages largely resolved, some telehealth companies—including Hims & Hers—have begun marketing lower-cost compounded oral versions. This has prompted legal action from Novo Nordisk, given that the proprietary SNAC technology is patented and critical to the drug’s validated bioavailability. The hosts caution that compounded oral formulations may lack regulatory oversight, standardized absorption data, and robust phase 1–4 clinical trial evidence. Without validated pharmacokinetics, patients risk receiving ineffective therapy—or potentially unsafe products—despite appealing lower price points.

The episode concludes with cautious optimism. While branding simplification and cost reductions represent meaningful progress in access and patient engagement, the hosts underscore the necessity of evidence-based prescribing and clinician-led patient education. As the GLP-1 therapeutic landscape continues to expand, maintaining safety, regulatory integrity, and pharmacologic rigor remains paramount.

Editor’s 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.

Podcasts

Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss Ozempic’s approval in a higher-dose oral form and lingering concerns over compounded drugs.

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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.

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

Type 1 Diabetes

Type 2 Diabetes

Strategic Alliance Partnership

Sophie Stocker, BsC, PhD, is a senior hospital scientist at St Vincent’s Hospital Sydney, and a senior lecturer at The University of Sydney

Wearable Device Delivers 5-Minute Data on Vancomycin Levels in Pilot Trial, With Sophie Stocker, MD

A pilot phase trial testing a wearable patch for continuous drug concentration measurement captured vancomycin levels in 5-minute intervals, demonstrating no safety or pain concerns in 6 participants.

Study investigators suggest further development of this electrochemical aptamer-based patch device could aid precising vancomycin dosing, thereby potentially preventing antibiotic-induced acute kidney injury.

“For a very long time, we've used trough concentrations to individualize therapy for drugs with a narrow therapeutic index, such as vancomycin, and it's quite a laborious process,” said study investigator Sophie Stocker, BsC, PhD, senior hospital scientist at St Vincent’s Hospital Sydney and a senior lecturer at The University of Sydney, in an interview with 

 “We're always looking in the rear view mirror because we're collecting data from doses that have already been administered to the patient.”

Vancomycin is the predominant frontline antibiotic clinicians use to treat severe, drug-resistant infections, including those associated with hospital acquired infections associated with medical devices, caused by coagulase negative staphylococci. Additionally, it is the primary alternative for patients with a penicillin allergy.

Despite its widespread use and efficacy, vancomycin can cause nephrotoxicity by accumulating with renal proximal tubule cells, leading to oxidative stress, mitochondrial dysfunction, and cellular apoptosis. This effect can be dose-dependent, with an increased risk at elevated concentrations > 20 mg/L or with prolonged therapy. Nephrotoxicity is a major cause of acute kidney injury, and can be linked to 60% of hospital-acquired causes.

“Vancomycin associated kidney injury often happens because we're only checking levels maybe once a day at best, twice a day in the intensive care setting,” said Stocker. “So this continuous real time monitoring with the wearable patch essentially changes that completely, because you've got this information coming every 5 minutes, so clinicians can see very quickly when vancomycin exposure is starting to get too high, and they can start adjusting the dose very early on to prevent then acute kidney injury.”

To improve on the current blood sampling practices, study investigators conducted the pilot phase trials of wearable ‘patches’ bearing electrochemical aptamer-based sensors on small, solid needles.

Overall, the patches were found to be safe and nearly pain-free, and they captured concentrations of vancomycin in the dermal interstitial fluid with 5-minute resolution over 24 hours. There was sensor degradation observed in participants, so the data primarily focuses on the first 12 hours.

Using fitting interstitial fluid and plasma concentrations to compartmental pharmacokinetic models, investigators observed distribution and clearance dynamics not currently detected with sparse sampling approaches. Additionally, when patches were placed at different sites on the body, they exhibited consistent trends.

Additional studies in clinical populations will be necessary to establish reliability over longer monitoring periods, validate correlations with plasma concentrations, and determine whether such data meaningfully improve dosing decisions or patient outcomes.

Stocker S, Erdal MK, Larson M, et al. Pilot phase clinical trial of a wearable, electrochemical aptamer-based patch for continuous drug concentration measurement. 

. Published online February 4, 2026. doi:

https://doi.org/10.1038/s41587-026-03010-w

Vazin A, Mahi Birjand M, Darake M. Evaluation of vancomycin therapy in the adult ICUs of a teaching hospital in southern Iran. 

Patel S, Preuss CV, Bernice F. Vancomycin. National Library of Medicine. Published October 29, 2024. 

https://www.ncbi.nlm.nih.gov/books/NBK459263/

Yasrebi-de Kom IAR, Jager KJ, Stel VS, et al. Vancomycin-Induced Acute Kidney Injury in Intensive Care Patients: A Target Trial Emulation Study Using Multicenter Routinely Collected Data. 

Kan WC, Chen YC, Wu VC, Shiao CC. Vancomycin-Associated Acute Kidney Injury: A Narrative Review from Pathophysiology to Clinical Application. 

International Journal of Molecular Sciences

Videos

Stocker discusses findings from a pilot phase trial with clinical insight into a wearable patch for continuous drug measurement of vancomycin. 


Muthiah Vaduganathan, MD, MPH, is a cardiologist specializing in cardiorenal metabolism at Brigham and Women's Hospital in Boston, MA. Vaduganathan is a member of Practical Cardiology's advisory board and co-host of Don't Miss a Beat, a podcast presented by Inside Cardiology.

Viet Le, DMSc, PA-C, is a preventive cardiology PA at Intermountain Health and the former president of the Academy of Physician Associates in Cardiology.

Smoothing the Road: Improving Heart Failure Awareness Among Clinicians and Patients

 is among the most devastating diseases in cardiology. Based on statistics from the Heart Failure Society of America (HFSA), HF contributed to 425,147 deaths in the US in 2022, accounting for 45% of all cardiovascular mortality. Roughly 6.7 million Americans >20 years have HF – this number is expected to reach 8.7 million by 2030, 10.3 million in 2040, and 11.4 million by 2050.

These statistics continue to rise in spite of a slew of available treatments and medications for HF and its associated risk factors. As more treatments are introduced and the overall prevalence of HF continues to increase, clinicians have largely turned to a lack of awareness of the options available to patients. Many drugs, including beta-blockers, mineralocorticoid receptor agonists, and SGLT2 inhibitors, have long since proven their efficacy in both clinical trials and real-world use; however, patient access to, and usage of, these drugs remain low.

In September of 2025, the Heart Failure Society of America and the American Society of Preventive Cardiology issued a joint statement on HF, aiming to reframe it as a preventable condition as opposed to an inevitable outcome. The document encouraged clinicians to prioritize the identification of risk factors, getting in front of the disease’s progression rather than treating it after it has manifested. It included strategies such as 

, lifestyle interventions, and genetic risk screening, among others.

Since the statement’s release, the HF conversation has largely shifted towards prevention. Multiple specialties, primarily nephrology and endocrinology, have been folded into the overall prevention cascade as more interdisciplinary treatments come to light. GLP-1 receptor agonists, such as semaglutide, have demonstrated substantial reductions in many risk factors for HF, while up-and-coming non-steroidal MRAs have provided promising results further upstream in the disease’s progression.

As we enter 2026, further research and progress can be enhanced by increasing awareness of the options available to patients. Addressing issues such as stepwise prescription and working through prior authorization can increase patient access to crucial medications. A more universal interpretation of HF as a preventable condition may bring more patients into the clinic as they learn the importance of locating risk factors early. And interdisciplinary work between heart failure clinicians and preventive cardiologists, as well as between specialties like nephrology and endocrinology, can enhance the care that we are already providing for patients.

Editor’s Note: Le reports disclosures with Janssen, Pfizer, Novartis, Idorsia, Amarin, and Lexicon. Gulati reports disclosures with Novartis, Esperion, Boehringer Ingelheim, and Merck. Vaduganathan reports disclosures with Amgen, AstraZeneca, Bayer AG, Cytokinetics, Lexicon, Boehringer Ingelheim, and others.

Fonarow GC, Ahmad FS, Ahmad T, et al. HF stats 2025: Heart Failure Epidemiology and Outcomes Statistics an updated 2025 report from the Heart Failure Society of America. Journal of Cardiac Failure. 2026;32(2):439-498. 

Heart Failure Society of America. Heart Failure Society of America and American Society for Preventive Cardiology Joint Statement Calls for a Shift in Heart Failure Prevention and Care. August 13, 2025. Accessed February 13, 2026. 

https://hfsa.org/heart-failure-society-america-and-american-society-preventive-cardiology-joint-statement-calls-0

This Heart Failure Awareness Week, revisit recent advancements and scope out the future of heart failure care with HCPLive.

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

vice president of programs, public affairs, and research at Lung Health Foundation.

Developers emphasize plain language, explicit next steps, and clear limits to ensure the PLCOm2012-based tool supports, rather than replaces, formal lung cancer screening.


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Safeguards in New Lung Cancer Risk Calculator, With Jessica Moffatt, PhD

Mark Kaufmann, MD, is a clinical professor in the Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City.

This segment of an interview from Maui Derm Hawaii, featuring Mark Kaufmann, MD, highlights key advice on AI scribe use and billing effectiveness in dermatology practices.

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Discussing AI Scribes and Improving Billing Practices in Dermatology, With Mark Kaufmann, MD

Zobair Younossi, MD, MPH, is chairman of the Global NASH/MASH Council and professor and chairman of Beatty Liver and Obesity Research at Inova Health System.

Younossi emphasizes the need for NIT-based risk stratification for MASLD, citing his research supporting their widespread adoption across clinical settings.

Hepatology

MASH / MASLD

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From Validation to Implementation: Scaling NITs in MASLD Care, With Zobair Younossi, MD, MPH

Rudolf Valenta, of the Medical University of Vienna

Valenta discusses how seasonal allergen exposure selectively boosts IgE production through plasmablast recall, without a coordinated IgG response.


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Seasonal Allergen Exposure Recalls IgE Plasmablasts in Birch Allergy, With Rudolf Valenta

Ruchika Goel, MD, is a professor and associate vice chair of research at SIU School of Medicine.

Low post-transfusion platelet increments did not predict mortality or length of stay in pediatric patients.

Hematology

When Platelet Increments Matter, With Ruchika Goel, MD

Jeffrey Downey, PhD, is a postdoctoral student at the Swirski laboratory at Icahn School of Medicine at Mount Sinai.

Downey discusses the recent discovery of influenza’s interaction with the interferon 1 pathway, as well as a hypothetical method for preventing it.

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

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Interferon 1 Responsible for Causing Cardiac Events During Influenza Infection, With Jeffrey Downey, PhD

The free, user-friendly calculator provides a 6-year lung cancer risk estimate to help patients and clinicians assess screening eligibility.


Tool Predicts a 6-Year-Risk Lung Cancer Risk in Minutes, With Jessica Moffatt, PhD

Survey findings highlight abdominal and bowel symptom control, affordability, and formulary or insurance coverage as factors driving perceptions and prescribing patterns of PERT.

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Real-World Prescribing Patterns of PERT in Exocrine Pancreatic Insufficiency

Mark Kaufmann, MD, speaks on maximizing your billing effectiveness in the era of dwindling reimbursements and ICD-10.

Strategies on Maximizing Billing Effectiveness for Clinicians, With Mark Kaufmann, MD

Younossi explains the growing interest in NITs for MASLD and reviews his research on their performance in age, diabetes, and obesity subgroups.

Latest News

Rethinking Early Detection of CKD: A Shift Toward Upstream Care

FDA Issues Complete Response Letter to Bitopertin For Erythropoietic Protoporphyria

Diabetes Dialogue: Oral Ozempic and the Risks of Compounding Formulas

Wearable Device Delivers 5-Minute Data on Vancomycin Levels in Pilot Trial, With Sophie Stocker, MD

Smoothing the Road: Improving Heart Failure Awareness Among Clinicians and Patients