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

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!

Interested in oncology news? Check out The OncFive, from our sister publication OncLive.

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

1. 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.

1. 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.

1. 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.

1. 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.

1. 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.

See you next week!

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