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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.

AI-powered control towers and digital twins are emerging as essential tools to prevent costly supply chain failures and restore operational reliability.

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.

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 first part of his Pharma Commerce video interview, Ed Schoonveld, value and access advisor for Schoonveld Advisory and author of The Price of Global Health, explains that affordability is only one pathway to securing a voucher—and reducing list prices isn’t the only way to demonstrate value.

In today’s Pharma Pulse, a structured exercise program is proven to manage persistent long COVID symptoms, while Regeneron commits $150 million upfront to Tessera for a gene writing therapy targeting AATD, and Strive Pharmacy invests in a massive Arizona facility to boost national personalized medicine capacity.

In today’s Pharma Pulse, a US-UK trade agreement mandates that the UK’s NICE agency raises its QALY threshold, increasing access to innovative drugs and much more.

In the final part of his Pharma Commerce video interview, Dan Walles, VP & GM, traceability and compliance solutions, TraceLink, notes that while DSCSA was designed for compliance, its first major business value is enabling targeted recalls.

The agreement includes exemptions for UK-produced drugs and medical devices from Section 232 tariffs, but mandates a significant change to the UK's NICE value appraisal framework.

In the second part of his Pharma Commerce video interview, Dan Walles, VP & GM, traceability and compliance solutions, TraceLink, describes how initial EPCIS setup issues quickly give way to operational challenges—missing data, mismatched shipments, and suspect product alerts. Dispensers that succeed are the ones developing repeatable, cross-partner exception workflows.

The pharmaceutical giant will be nearly doubling biologics production in Frederick and build a new clinical supply facility in Gaithersburg, projects that will create thousands of jobs, enhance US supply chain resilience, and advance its growing rare disease portfolio.

While studies reveal the complex, varying, and long-lasting burden of Long COVID symptoms, biopharma giants Novartis and Moderna commit significant capital to new facilities, reinforcing US drug supply resilience in today’s Pharma Pulse.

Pharma Pulse: FDA Appoints Richard Pazdur as CDER Director Amid 340B Tensions and Novartis Expansion
This episode of Pharma Pulse discusses how Dr. Richard Pazdur’s appointment signals a new era for FDA drug evaluation, why hospitals are opposing the government’s 340B pilot program, and how Novartis is expanding its US manufacturing footprint with a new radioligand therapy facility in California.

The pharma giant’s new 10,000-square-foot Carlsbad plant strengthens its US manufacturing network and supports its overarching $50 billion investment plan committed to operations.

The investment is aimed at boosting oral medicine manufacturing capacity.

This episode of Pharma Pulse discusses Novartis’ $12 billion acquisition of Avidity Biosciences to expand its RNA therapeutics portfolio, and President Trump’s proposed 10% tariff increase on Canadian imports that could disrupt pharma supply chains.

The move adds new tension to US-Canada trade relations under the USMCA and raises questions about pending pharmaceutical import policies.

The CDMO’s latest investment will boost capacity at its Charles City, IA facility by 40%, underscoring Cambrex’s focus on reshoring drug manufacturing, advancing peptide and small molecule production, and supporting the long-term stability of the US pharma supply chain.

The acquisition brings together two leaders in mRNA innovation, strengthening BioNTech’s oncology strategy and expanding its R&D and commercialization capabilities.

The company’s new 400,000-square-foot facility in Elkton will boost small molecule manufacturing, create hundreds of jobs, and strengthen US innovation and supply chain resilience.

The $445 million expansion of AstraZeneca’s Coppelsite will boost global production capacity for Lokelma, enhance local job growth, and strengthen the company’s US manufacturing footprint amid industry-wide onshoring trends.

A planned 100% tariff on branded and patented drugs from Singapore is being postponed as US and Singapore officials explore potential exemptions.

The fallout is impacting partners Scholar Rock and Regeneron, both of whom have pending regulatory applications tied to the facility.














