HCPLive Editorial Staff

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories included sotagliflozin cutting cardiovascular risk in diabetes, the US Food and Drug Administration (FDA) greenlighting a Phase 3 pathway in hepatology, a new approval for atopic dermatitis, expert consensus on anaphylaxis care, and the end of the semaglutide shortage.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of February 16, 2025—let’s jump in!

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Top News for Healthcare Providers from the Week of 02/16

Sotagliflozin Cuts MACE Risk By 23% in Patients with Type 2 Diabetes, CKD

Sotagliflozin, a dual sodium-glucose cotransporter (SGLT) 1/2 inhibitor, reduced major adverse cardiovascular event (MACE) risk in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). In a prespecified analysis of the SCORED randomized trial, sotagliflozin achieved a 23% reduction in the rate of myocardial infarction, stroke, and cardiovascular death, compared with the placebo group.

Nebokitug (CM-101) Gets FDA Runway for PSC Approval

Chemomab Therapeutics completed an end-of-Phase-2 meeting with the FDA and aligned on the design of a single Phase 3 registrational study for nebokitug (CM-101) for primary sclerosing cholangitis (PSC). The trial provides the first regulatory update on a streamlined path to full approval based on a single pivotal trial that does not require liver biopsy and uses a primary endpoint of clinical events associated with disease progression in PSC.

FDA Clears IND Application for Zabalafin Hydrogel Treatment of Atopic Dermatitis

The FDA approved the Investigational New Drug (IND) application for Alphyn Biologics, Inc.’s zabalafin hydrogel, a treatment option for mild-to-moderate atopic dermatitis. Zabalafin hydrogel targets multiple aspects of atopic dermatitis, reducing the characteristic pruritus associated with the condition, targeting its bacterial component, and modulating the underlying immuno-inflammatory response.

Expert Panel Develops Consensus Definition, Clinical Tool for Anaphylaxis Care

A 46-member expert panel developed a consensus anaphylaxis definition, overview, and clinical support tool based on feedback from medical and patient advocacy organizations. The determined definition defined the condition as a rare serious allergic reaction that can progress rapidly and may cause death. It may involve the skin/mucosa (includes lip/tongue) respiratory (lungs, breathing), cardiovascular (heart, blood pressure), and/or gastrointestinal (stomach/gut) systems.

FDA Announces End to Shortage of Semaglutide Products (Ozempic, Wegovy)

The FDA declared the shortage of Novo Nordisk’s semaglutide injection (Ozempic) and semaglutide injection 2.4 mg (Wegovy) as over, resolving the notable supply issues for the management of type 2 diabetes and obesity. The supply of semaglutide products in the US now meets or exceeds the current and expected demand, potentially causing issues for the compounding boom that grew in its wake.

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The latest healthcare updates include significant advancements and regulatory developments. Sotagliflozin has shown a 23% reduction in major adverse cardiovascular events in patients with type 2 diabetes and chronic kidney disease. Chemomab Therapeutics has aligned with the FDA for a Phase 3 trial of nebokitug for primary sclerosing cholangitis. The FDA approved an IND application for zabalafin hydrogel for atopic dermatitis. An expert panel has developed a consensus definition for anaphylaxis care. The FDA announced the resolution of the semaglutide shortage, impacting diabetes and obesity management.

Our top 5 headlines included a new approval for atopic dermatitis, expert consensus on anaphylaxis care, and the end of the semaglutide shortage.

The HCPFive: Top News for Healthcare Providers from the Week of 02/16

While research has advanced our understanding of food allergy prevention, translating these findings into clinical practice requires careful consideration of individual patient factors, risk stratification, and parental guidance. The American Academy of Allergy, Asthma & Immunology (AAAAI), American College of Allergy Asthma and Immunology (ACAAI), and Canadian Society of Allergy and Clinical Immunology (CSACI)’s consensus guidance provides a framework for clinicians to implement evidence-based strategies for allergy prevention while addressing the concerns of families and caregivers. Key topics include identifying infants at high risk for food allergies, assessing readiness for allergenic food introduction, and recognizing when additional precautions—such as specialist referral or supervised feeding—may be necessary.

Beyond early introduction and dietary diversity, the guidelines also discuss broader clinical implications, including the impact of feeding patterns, the role of probiotics, and the evolving understanding of food protein-induced allergic disorders. Effective counseling strategies, shared decision-making with families, and addressing misinformation are essential components of implementing these recommendations.

AAAAI will be holding its 2025 AAAAI/World Allergy Organization (WAO) Joint Congress on February 28-March 3 in San Diego, California. Stay tuned to 

for the latest updates live to you from the meeting.

In this quiz, the last in a series of 3, we will evaluate your knowledge of best practices for clinical assessment, counseling, and management strategies in the primary prevention of food allergy.

C. Conduct an oral food challenge under medical supervision

D. Retest IgE levels every few months before introduction

This quiz was created in part with AI, based off of guidelines from the reference document below.

Abrams EM, Shaker M, Stukus D, Mack DP, Greenhawt M. Updates in Food Allergy Prevention in Children. 

 2023; 152 (5): e2023062836. doi: 10.1542/peds.2023-062836

Recent advancements in food allergy prevention research necessitate careful integration into clinical practice, considering individual patient factors and risk stratification. Consensus guidance from leading allergy organizations offers a framework for implementing evidence-based strategies, focusing on high-risk infants, allergenic food introduction, and necessary precautions. The guidelines also address broader clinical implications, such as feeding patterns, probiotics, and food protein-induced allergic disorders. Effective counseling, shared decision-making, and combating misinformation are crucial for successful implementation. The upcoming AAAAI/WAO Joint Congress will provide further insights into these evolving practices.

In this quiz, we test your knowledge of recommendations to prevent food allergy development in infants.

Clinical Quiz: Clinical Considerations in Food Allergy Prevention

The role of diet in shaping immune tolerance has become an important area of research in allergy prevention. Emerging evidence suggests that a diverse diet during infancy and early childhood may play a protective role in reducing the risk of developing allergic diseases, including food allergies, asthma, and eczema. The American Academy of Allergy, Asthma & Immunology (AAAAI), American College of Allergy Asthma and Immunology (ACAAI), and Canadian Society of Allergy and Clinical Immunology (CSACI)’s consensus guidance highlights dietary diversity as a crucial factor in the development of immune resilience, recommending the introduction of a broad range of foods early in life to support immune system development.

In addition to introducing common allergens, the guidelines emphasize the importance of varied nutrient sources, exposure to different food groups, and minimizing overly restrictive diets unless medically indicated. Factors such as gut microbiome development, maternal diet during pregnancy and lactation, and environmental influences are also discussed as contributors to allergy risk. 

In this quiz, the second in a series of 3, we will assess your understanding of the evidence supporting dietary diversity, the relationship between nutrition and immune tolerance, and practical strategies for incorporating diversity into early childhood feeding practices.

C. To reduce the risk of developing food allergies

D. To make meal planning easier for parents

Research indicates that a diverse diet during infancy and early childhood may reduce the risk of allergic diseases. Key organizations emphasize dietary diversity as crucial for immune resilience, recommending early introduction of a broad range of foods. Guidelines also highlight the importance of varied nutrient sources and caution against overly restrictive diets unless necessary. Factors like gut microbiome development, maternal diet, and environmental influences are also considered in allergy risk. The upcoming AAAAI/WAO Joint Congress will provide further insights into these findings.

In this quiz, we test your knowledge of recommendations for introducing dietary diversity to infants.

Clinical Quiz: Dietary Diversity and Allergy Prevention

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? 

Top 5 healthcare headlines  for February 09 - 16, 2025:

FDA Accepts Lerodalcibep BLA for LDL-C Reduction in High-Risk Patients


Announced by LIB Therapeutics Inc., the agency has set a PDUFA target action date of December 12, 2025.

Travere Therapeutics Plans FSGS Submission for Sparsentan


An approval for sparsentan in focal segmental glomerulosclerosis would mark the second rare kidney disease approval for the agent.

Bimekizumab Long-Term Hidradenitis Suppurativa Data Support Efficacy, Safety Profile


New 2-year data from the BE HEARD program shed further light on the role bimekizumab in treatment algorithms for HS.

Rosnilimab Demonstrates Historic Responses for Rheumatoid Arthritis


The Phase 2b RENOIR trial met its primary endpoint and key secondary endpoints in patients with RA in new 12-week data.

FDA Expands Dosing Label for Avacincaptad Pegol for Geographic Atrophy


The FDA approved an expanded label for avacincaptad pegol, removing limitations on the duration of dosing beyond 12 months.

The recent healthcare updates include the FDA's acceptance of Lerodalcibep's BLA for LDL-C reduction in high-risk patients, with a PDUFA date set for December 2025. Travere Therapeutics plans to submit sparsentan for FSGS, potentially marking its second approval for a rare kidney disease. Bimekizumab's long-term data supports its efficacy and safety in treating hidradenitis suppurativa. Rosnilimab showed promising results in the RENOIR trial for rheumatoid arthritis. The FDA expanded the dosing label for avacincaptad pegol, allowing extended use for geographic atrophy.

An audio recap of the top 5 stories in healthcare news from the week of 02/09-02/16.