Nicholas Saraceno, Senior Editor

In today’s Pharma Pulse, Novartis and Moderna anchor a domestic manufacturing surge, while AI-driven biomarker discovery and physician well-being reshape the future of clinical care.

The pharmaceutical giant’s new 700,000-square-foot hub aims to onshore production of key medicines and strengthen the US drug supply chain.

CoverMyMeds’ Megan Wetzel unpacks the forces behind rising specialty spend, the real impact of access barriers, and how field reimbursement teams help providers guide patients through today’s fragmented system.

Cheryl Allen, BS Pharm, MBA, founding partner, highlights the coming year's focus on navigating an evolving regulatory landscape, while leveraging technology to track the pharmaceutical pipeline, assess analogs, and modernize distribution strategies.

In today’s Pharma Pulse, SOBI strengthens its gout franchise by acquiring Arthrosi Therapeutics for up to $1.5 billion, securing the Phase III asset pozdeutinurad, and much more.

A session explores how manufacturers can refine GTN strategy, strengthen pricing governance, and navigate increasingly complex distribution-channel economics, while maintaining both commercial performance and patient affordability.

In a wide-ranging keynote on disruption across pharmaceutical channels, Bill Roth, general manager and managing partner of IntegriChain’s consulting business, outlines why 2025 marks the beginning of a profound regulatory and commercial transformation—from sweeping policy shifts and accelerating WAC reductions to new debates on direct-to-patient strategies and looming instability in medical benefit reimbursement.

In today’s Pharma Pulse, the FDA approves Amgen’s Uplizna (inebilizumab-cdon), the first CD19-targeted therapy for gMG with convenient twice-yearly dosing, and much more.

BioCare's Ryan Cort outlines the pharmaceutical industry's "unprecedented sea change," driven by over $400 billion in anticipated revenue loss from generics and biosimilars losing exclusivity.

Cheryl Allen, BS Pharm, MBA, founding partner, Curatio Scientia Advisors, hopes to use the conference to explore how manufacturers can build the talent and support structures required to keep the US drug supply safe and accessible.

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and let’s get into today’s headlines.

Jay McHarg, CEO of AeroSafe Global, reacts to the next generation of pharma delivery using innovations such as reusable packaging, integrated delivery systems, and real-time delivery intelligence.

Jay McHarg, CEO of AeroSafe Global, explains how a Targeted Risk Improvement Program improves resilience, reduces costs, and strengthens sustainability across the supply chain.

Jay McHarg, CEO of AeroSafe Global, discusses the significance of rethinking the “last mile” as the first moment of patient care—using real-time Active Delivery Management—for proactive and improved pharmaceutical logistics.

Hear how “delivery intelligence” is transforming the last mile of pharmaceutical logistics from Jay McHarg, CEO of AeroSafe Global.

As the FDA ends its phased exemption period for most trading partners, Two Labs’ Michael Rowe warns that DSCSA compliance is entering a far more complex era—one shaped by real-time traceability, digital record requirements, and a transition to a 12-digit NDC.

Cheryl Allen, BS Pharm, MBA, founding partner, Curatio Scientia Advisors, discusses how the convergence of patient access services with traditional distribution models is setting the stage for medically integrated dispensing to expand beyond oncology.

In today’s Pharma Pulse, Augmentin XR is the first drug approved under the FDA's new CNPV pilot program and much more.

Cheryl Allen, BS Pharm, MBA, founding partner, Curatio Scientia Advisors, highlights how two decades of commercial trade and distribution have transformed the channel from a primarily supply-chain-focused function into a more integrated discipline.

Subject matter experts from Cencora and FuzeRx explore how modern commercialization models, digital-first pharmacy solutions, and closer provider partnerships are reshaping patient access and adherence across today’s complex therapeutic landscape.

In today’s Pharma Pulse, the University of Maryland expands its medical class to combat physician shortages and much more.

Commercialization expert Bill Roth outlines the critical need for "adaptive capacity," detailing how accelerating government regulation and massive patent cliffs are forcing a complete overhaul of commercial strategies across various markets.

In the final part of his Pharma Commerce video interview, Colin Banas, MD, DrFirst’s chief medical officer, explains how amid soaring patient and provider frustration, new HTI-4 standards are rapidly forcing change across the insurance and technology sectors to solve the current "transparency problem," making the status of a life-saving prescription as clear and actionable as tracking a takeout order.

In today’s Pharma Pulse, new trials confirm AI chatbots are a successful and sustainable tool for increasing pneumococcal vaccine uptake among older adults and much more.

In the second part of his Pharma Commerce video interview, Colin Banas, MD, DrFirst’s chief medical officer, points out that while real-time benefit tools are improving coverage visibility at the point of care, true efficiency requires actionable insights and standardized ePA, an area still “laying the tracks.”

In today’s Pharma Pulse, the ACIP votes to end the decades-long universal hepatitis B birth dose recommendation; meanwhile, former FDA commissioners warn that new vaccine policies are compromising the long-standing regulatory framework and jeopardizing public health security.

The entrepreneur urges the Trump administration to eliminate costly FDA generic drug fees, part of a broader push to scale domestic production, address shortages, and challenge PBM-driven pricing models.

In the final part of his Pharma Commerce video interview, Ed Schoonveld, value and access advisor for Schoonveld Advisory and author of The Price of Global Health, previews his December column, exploring US price-referencing guidance, its impact on innovation, and whether this marks the beginning of broader pricing controls.

In today’s Pharma Pulse, Dr. Tracy Beth Høeg is named acting CDER director amidst high leadership turnover, promising modernization and transparency.

The pharma distribution giant is scaling its third-party logistics network across Europe and the United States, adding cryogenic capacity, new facilities, and enhanced cold chain services, to support rising demand for specialty pharmaceuticals and global market access.