The Rx Recap: March 23-29

Welcome to this week’s roundup of the most insightful and impactful articles from the sister publications of Dermatology Times, all under One MJH Life Sciences. Our network brings together expert perspectives, clinical advancements, and industry updates to keep clinicians informed and ahead of the curve. From cutting-edge treatments to practice management strategies, here’s a look at the top stories shaping the field of medicine.

Secretome Therapeutics Doses First Patient in Phase 1 Trial for Heart Failure Cell Therapy STM-01

A recent CGT Live article highlights Secretome Therapeutics' groundbreaking progress in cell therapy for heart failure with preserved ejection fraction (HFpEF). The company has dosed the first patient in a phase 1 clinical trial (NCT06560762)evaluating STM-01, an investigational allogeneic neonatal cardiac progenitor cell-derived therapy. As the first trial to assess an allogeneic stem cell therapy for HFpEF, the study explores STM-01’s potential to reduce inflammation, support tissue repair, and improve cardiac function. With FDA fast track designation and large-scale GMP manufacturing in place, Secretome is positioning STM-01 as a potential game-changer in the HFpEF treatment landscape. The CGT Live article also notes that other companies, such as Sardocor, are advancing gene therapy alternatives, showcasing the growing innovation in advanced heart failure therapeutics.

Anticipating Fitusiran’s Approval for Factor-Agnostic Hemophilia A, B, with Robert F. Sidonio Jr., MD, MSc

The FDA is nearing a decision on fitusiran prophylaxis in adults and adolescents over the age of 12 years with hemophilia A or B, with or without inhibitors, as we near the therapy’s Prescription Drug User Fee Act (PDUFA) date of March 28. The agency previously accepted Sanofi’s biologics license application (BLA) in June 2024.

HCPLive spoke with Robert F. Sidonio Jr., MD, MSc, who is a Pediatric Hematologist/Oncologist, Medical Director of Hemophilia, and Medical Director of the Clinical Research Office at Aflac Cancer & Blood Disorders Center and Children's Healthcare of Atlanta, as well as an Associate Professor of Pediatrics at Emory University School of Medicine, to learn more about fitusiran and its potential to add to the treatment landscape of both hemophilia A and B.

FDA Approves UTI Antibiotic, Blujepa

A recent Managed Healthcare Executive article highlights GSK’s FDA approval of Blujepa (gepotidacin), a first-in-class antibiotic designed to treat uncomplicated urinary tract infections (uUTIs) in females aged 12 and older. With uUTIs affecting up to 16 million women annually and drug resistance on the rise, Blujepa represents a major advancement in antimicrobial treatment. The approval is based on Phase 3 EAGLE-2 and EAGLE-3 trials, where Blujepa demonstrated superior symptom relief compared to nitrofurantoin, a leading uUTI treatment. Expected to launch in late 2025, Blujepa offers a new mechanism of action to combat resistant bacteria, addressing a critical need in women's health care.

Pharma’s Response to the Biosecure Act

In a video interview with Pharma Commerce, Brad Stewart, BDO’s national life sciences co-leader, describes the challenges that tariffs may pose to reshoring manufacturing services in the life sciences industry. He highlights the complexity of supply chains in this sector, which are large, long, highly-regulated, and slow to change. Given that future administrations may alter tariff policies, reshoring decisions need to account for the potential reversal of these changes. While it can be more expensive, prioritizing US-based manufacturing capacity can help de-risk supply chains, particularly as tariffs and uncertainty continue to affect global operations.

FDA Clears Gleamer’s ChestView AI Software for CXR

Finally, Diagonstic Imaging informed readers that the Food and Drug Administration (FDA) has granted 510(k) clearance for ChestView, an artificial intelligence (AI)-enabled software, which may enhance detection of a variety of abnormalities on chest X-rays (CXRs).

In a 2023 retrospective study involving 500 patients, researchers found that adjunctive use of the ChestView software led to an average increased detection of 26.2 percent for pneumothorax, 8.5 percent for pleural effusion and 14.1 percent for consolidation.

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