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Empowering Scientific Dialogue: Key Takeaways from the FDA’s SIUU Guidance
Posted by
Anne Marie Robertson , Tim Lewis , Susan Giacalone, MSN, BCMAS, MSL-BC on July 21, 20257/21/25
Discover the latest insights from the FDA’s finalized guidance on Scientific Information on Unapproved Uses (SIUU). This comprehensive document provides a clarified framework for pharmaceutical companies to share scientifically sound information with healthcare providers. In this…
Bridging the Evidence Gap in Hereditary Angioedema (HAE): Indirect Comparison Highlights Garadacimab’s Potential
Hereditary angioedema (HAE) is a rare, debilitating condition marked by unpredictable and potentially life-threatening swelling episodes. While long-term prophylactic therapies have significantly improved disease management, selecting the optimal treatment remains complex—particularly in the absence of direct…
Where Process Meets Profit: How Strategic Order to Cash Drives Real Revenue Outcomes
Is your Order to Cash (OTC) process helping you maximize revenue—or quietly leaking it? In their latest article, EVERSANA experts Christina Christos and Jim Burke explore how pharmaceutical manufacturers can align OTC and Revenue Management to…
Navigating the Not-So-Direct Path to Access – A Pharmacist’s Perspective
Originally published on Drug Channels July 11, 2025 The traditional healthcare system built for yesterday’s healthcare doesn’t serve today’s patients or advanced therapies. Lindsay Reel, VP of Pharmacy Practice & Specialty at EVERSANA, shares her frontline…
Staying Ahead of the Curve in Pharmacovigilance: Inspection Metrics Report for 2023 by Egyptian Drug Authority (EDA)
In an era where patient safety and regulatory compliance are more critical than ever, staying informed about global pharmacovigilance trends is essential. The Egyptian Drug Authority (EDA) recently released its 2023 Pharmacovigilance Inspection Metrics Report, offering…
Staying Ahead of the Curve in Pharmacovigilance: ANVISA RDC No. 967/25
As the regulatory landscape continues to evolve, staying compliant with new pharmacovigilance requirements is more important than ever. Our Pharmacovigilance experts actively track evolving global regulations—so you don’t have to. What You Need to Know About…
Staying Ahead of the Curve in Pharmacovigilance: Decentralized Manufacture — UK Guidelines of Good Pharmacovigilance Practices
Our Pharmacovigilance experts actively track evolving global regulations—so you don’t have to. To help simplify pharmacovigilance, we stay ahead of new regulations and guidelines, assess their impact and recommend actions that empower professionals to update their…
Reimagining Patient Health Experiences: A New Paradigm for Transforming Lives
Traditionally, the healthcare system has approached patient care, especially for those with acute conditions and rare diseases, through a lens of sympathy, problem-solving, and normalization. The focus has often been on identifying deficits and developing tools…
Comparing Long-Term HAE Treatments: Insights from a Robust Network Meta-Analysis
Hereditary angioedema (HAE) is a rare genetic disorder characterized by recurrent edema attacks in various parts of the body, including the extremities, face, gastrointestinal tract, and airway. While most current treatments can help relieve acute symptoms…
Transformative Commercialization for New BioPharma Entrants Ensuring Success with Capital and Time Efficiency
In an EVERSANA-led discussion, experts Maneesh Gupta, Jennifer Meeuwsen, Anne Marie Robertson, and Iterum Therapeutics CEO Corey Fishman discussed key challenges for first-time biopharma launchers and shared strategies for success. Key Challenges: 3x lower net revenue…