Osmessn.com

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. […]

In the fourth part of his Pharma Commerce video interview, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, explains the lessons pharma leaders in traditional therapeutic areas can learn from CGT’s highly specialized operational strategies, particularly in terms of supply chain resilience and adaptability.

2025 DIA Annual Meeting: The Importance of Early Patient Feedback in Digital Endpoint Development In an interview with Applied Clinical Trials at the 2025 DIA Annual Meeting, Brian Ongioni, chief product officer, uMotif, emphasized the importance of incorporating early patient and site feedback into the digital health product lifecycle to ensure digital endpoints are accessible, […]

As international price referencing tightens and payer expectations rise, companies face a shrinking margin for error. The panel explores how clinical trial design and early payer engagement are key to meeting both regulatory and reimbursement demands across global markets. With real-world evidence (RWE) from markets like Korea and Japan in hand, forward-thinking strategies can prove […]

How CRO Partnerships Are Evolving to Meet Changing Industry Demands In an interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer, Novotech, emphasized the need for CRO partnerships to become more collaborative, cost-efficient, and insight-driven in response to evolving regulatory and funding challenges, highlighting Novotech’s award-winning collaboration with Tune Therapeutics as a model […]

2025 DIA Annual Meeting: How AI and Machine Learning Can Improve Patient Reported Outcomes in Clinical Trials In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer at uMotif, explained how the company integrates patient and site feedback early in the development process to improve the usability and regulatory strength of digital health […]

In this Pharmaceutical Commerce roundtable discussion, Nicholas Saraceno, editor of Pharmaceutical Commerce and the peer exchange’s moderator, introduced a discussion on the pharmaceutical supply chain, highlighting its complexity and importance in delivering medications safely and efficiently from manufacturers to patients. The conversation explored the roles of various stakeholders, the need for supply chain resilience and quality control, […]

Pharmaceutical Commerce: FDA staff cuts have created a critical gap in adverse drug event (ADE) monitoring. With ADEs being the third leading cause of death in the United States,1 what role do you see AI playing in preventing these events, especially when up to 56% are considered preventable through faster detection? Dipanwita Das: For decades, […]

Investigators aimed to examine the quality and efficiency under the FFS MA and at-risk MA models as a way to measure both the quality and resources that are being utilized. Image Credit: Adobe Stock Images/SatoriStudio.com More than 50% of Medicare beneficiaries elect to join Medicare Advantage (MA), which has out-of-pocket (OOP) spending limits, along with […]

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 […]