Manufacturing & Packaging

In the fourth part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, cautions that stockpiling to offset tariffs could backfire for pharma companies, leading to expired inventory, higher waste, and costly trade-offs, unless renegotiation strategies are pursued.

As of today, Aug. 27, wholesale distributors must fully comply with the Drug Supply Chain Security Act’s enhanced drug distribution requirements, closing the FDA’s exemption period and advancing efforts to strengthen patient safety and supply chain integrity.

This episode of Pharma Pulse covers the FDA’s new daily adverse event reporting initiative, the CDC’s appointment of an mRNA vaccine critic to lead its COVID-19 immunization workgroup, and Genentech’s $700 million investment in a North Carolina biologics facility.

The new 700,000-square-foot Holly Springs site—part of Roche’s $50 billion US investment plan—will focus on metabolic and obesity treatments, create 400 jobs, and strengthen domestic biopharma manufacturing amid shifting tariff and drug pricing policies.

This episode of Pharma Pulse covers FDA findings of contamination and safety lapses at Novo’s Bloomington manufacturing plant, the rise of off-label GLP-1 prescribing and its equity challenges, and AbbVie’s acquisition of bretisilocin to advance treatments for major depressive disorder.

An FDA Form 483 cited unaddressed contamination, pest infestations, and equipment failures at manufacturer’s Bloomington, IN facility, which was acquired in the Catalent buyout.

Addressing the most common concerns surrounding the legislation intended to establish interoperability within the pharma supply chain.

This episode of Pharma Pulse covers the White House–EU agreement on pharmaceutical tariffs, Johnson & Johnson’s $2 billion expansion of its North Carolina manufacturing site, and a new federal rule requiring e-prescribing and prior authorization tools in certified EHR systems.

The new framework, set to take effect Sept. 1, limits tariffs on pharmaceutical imports to 15% but follows months of shifting proposals, including threats of tariffs as high as 250%.

In the fourth part of his Pharma Commerce video interview, Mark Lee, MarqVision’s founder and CEO, discusses how healthcare companies and regulators can strengthen defenses against counterfeit drugs by integrating AI with physical authentication methods and enabling secure, anonymized data sharing across the pharm sector.

The company will be heavily investing over the next decade to build a new biopharmaceutical facility in Holly Springs, NC, creating 120 jobs and reinforcing its $55 billion pledge to strengthen US manufacturing, R&D, and innovation.

In the third part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, discusses how predictive analytics, AI, and automation are streamlining US pharmaceutical manufacturing—cutting overhead, boosting efficiency, and enhancing safety.

The CDMO will be cutting 350 jobs at its Baltimore gene therapy site after a major client’s demand shift, less than a year after Novo Holdings’ $16.5 billion acquisition.

This episode of Pharma Pulse explores a Battelle–Aprecia partnership with HHS and DARPA to accelerate on-demand drug manufacturing, a multi-billion-dollar Merck KGaA–Skyhawk collaboration to advance RNA therapies in neurology, and how pharmacist-led telehealth is improving diabetes care during emergencies.

The EQUIP-A-Pharma program will combine Battelle’s synthesis platform and Aprecia’s 3D printing technology to produce APIs and finished drugs at the same site, aiming to strengthen US pharma supply resilience and support essential medicines.

In the eighth part of this roundtable discussion, supply chain experts emphasize that effective manufacturing strategies depend on product type, market location, and regulatory complexity, requiring a careful balance between outsourcing, internal production, regional distribution, and patient-centric priorities.

This episode of Pharma Pulse discusses a new executive order to build a domestic API stockpile, Eli Lilly’s 170% price increase for Mounjaro in the UK, and long-term research confirming the safety of aluminum in childhood vaccines.

In the second part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, outlines how the impact of a steep pharmaceutical import tariff varies across raw materials, components, and finished products, along with why such a policy could incentivize companies to shift production to the US.

The directive calls for building a six-month Strategic Active Pharmaceutical Ingredients Reserve, updating the essential medicines list, and prioritizing US-made APIs.

Despite the ongoing turmoil over tariffs, medicine costs, and FDA policy, US wholesalers are performing well.

This episode of Pharma Pulse explores AbbVie’s $195 million investment to expand US API production, new survey results showing mail-order and supermarket pharmacies outpacing traditional chains in customer satisfaction, and rising affordability pressures as insurers restrict GLP-1 coverage.

The new North Chicago facility, slated to open in 2027, will boost domestic production of key drug ingredients for immunology, neuroscience, and oncology therapies, reinforcing US pharmaceutical capacity amid industry reshoring and tariff concerns.

The CDMO’s new services at its Hopewell, NJ facility delivers scalable, phase-appropriate production, in-house quality control, and domestic sourcing to help gene therapy developers reduce complexity, speed timelines, and ensure regulatory compliance.

A new two-phase initiative aims to streamline facility approvals, reduce reliance on foreign pharmaceutical production, and bolster domestic supply chain resilience amid rising tariffs and reshoring investments.

Meanwhile, drugmakers ramp up US manufacturing investments to navigate policy shifts and protect supply chain resilience, as the Trump administration enacted tariff rates between 10% to 50% on various trading partners early this morning.