Month: July 2025

The trust gap between real-world evidence (RWE)/data and randomized controlled trials is growing. This episode examines when each evidence type is appropriate, how to reduce perceived bias in RWE, and how payer context varies by geography and structure. Insights from academic and payer partnerships show how joint research can establish credibility and unlock market access. […]

A qualitative study explored how representatives from MA plans, kidney care management companies, and dialysis organizations view the expansion and marketing of MA products for individuals with ESKD. Image Credit: Adobe Stock Images/CrystalLight.com By this year, enrollment in Medicare Advantage (MA) plans, which feature private managed care insurers to receive payments from the governments to […]

PC: What risks do you foresee for companies developing first-in-class therapies if patient perspectives are no longer formally incorporated into regulatory discussions? Leuchter: Eliminating patient perspectives from regulatory discussions would remove a key source of value—especially in the context of rare or recently characterized diseases. In many of these cases, there are no formal natural […]

2025 DIA Annual Meeting: Building Patient Centricity into Clinical Trial Software from Day One In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer, uMotif, discussed how the company integrates patient and site feedback from the earliest stages of software development to create intuitive, regulatory-ready digital health tools that reduce burden and improve […]

Image Credit: Adobe Stock Images/TadaImages.com As a result of the Patient Protection and Affordable Care Act (ACA), 24.2 million people enrolled in the health insurance marketplaces this year, a record number.1 However, sustaining that coverage can potentially be a major challenge, given the administrative obstacles that they can face. Why zero-dollar premium plans matter for […]

Preparing for Federal Regulations: Q&A with John Stanford In an interview with Pharmaceutical Executive, John Stanford, executive director at Incubate, emphasized the importance of sustained investment in early-stage biotech to drive long-term innovation and ensure a robust drug development pipeline. Funding Cuts Threaten Diversity in Clinical Research In an interview with Applied Clinical Trials, Kyle […]

Novo Nordisk is growing coverage of its Wegovy injection 2.4 mg in the form of a new deal with WeightWatchers that takes effect July 1. Image Credit: Adobe Stock Images/Syahrir.com Novo Nordisk is growing coverage of its Wegovy (semaglutide) injection 2.4 mg in the form of a new deal with WeightWatchers that takes effect July 1.1 […]

Oncology Care Index Spurs J&J to Address Fragmentation in Cancer Treatment In an interview with Pharmaceutical Executive, Biljana Naumovic, US President, oncology, solid tumor, Johnson & Johnson Innovative Medicine, shared how insights from the company’s Oncology Care Index are shaping efforts to reduce fragmentation in cancer care by expanding community-based clinical research, improving care continuity, […]

The Impact of FDA’s Ban on Compounded GLP-1s A Pharmaceutical Executive article explores how the FDA’s ban on compounded semaglutides—following stabilized supply from Novo Nordisk and Eli Lilly—has significantly disrupted access for patients who relied on these lower-cost alternatives, prompting Olympia Pharmaceuticals to shift its focus to legal and in-demand options like liraglutide. How Sites […]

This investment exemplifies Hikma’s interest in raising the volume of meds it creates and produces across its various R&D and manufacturing sites in Columbus and Cleveland, OH and in Cherry Hill and Dayton, NJ. Image Credit: Adobe Stock Images/Deep.com Hikma Pharmaceuticals USA today will be financially committing $1 billion by the year 2030 to further grow its US manufacturing and R&D capabilities.1 With an investment of […]

In a video interview with Pharma Commerce, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, discusses the evolving state of global cell and gene therapy commercialization. Sawicki highlighted significant progress in key operational areas, noting that companies are now better prepared for commercial launches than in the past. Early challenges in manufacturing readiness have been […]

Historically, new drugs were approved for a single therapeutic use. However, industry trends have shifted, with pharmaceutical companies increasingly identifying and developing additional indications for existing medicines. This approach is supported by regulatory agencies such as the FDA and EMA, which recognize the value of leveraging established safety profiles for new uses. As a result, […]

PC: What role has public participation historically played in shaping healthcare policy, and why is it important for pharma and biotech companies? Leuchter: Public participation has played a critical role, for many of the reasons I mentioned earlier. But I’d like to expand on one area I haven’t touched on yet: education. In many cases—especially […]

Medicaid is especially critical for children with rare diseases, due to their need for intensive specialty care and higher risk for financial distress. Image Credit: Adobe Stock Images/Ivlianna.com In the United States, Medicaid is considered the largest payer of healthcare, serving nearly a quarter of the total population; this includes nearly 40 million children. And […]

Real-world evidence (RWE) is no longer optional—it’s expected. This episode dives into how payers assess RWE alongside clinical trial data, especially in competitive therapeutic areas. The panel stresses the importance of linking RWE to financial outcomes and making data relevant to specific patient populations. It’s not just about data quality; it’s about context and credibility. […]