Business and Finance

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.

This episode of Pharma Pulse covers a $290 million False Claims Act ruling against CVS Caremark, a new report showing most small medical practices fall short on HIPAA compliance, and research revealing why pharmacists underreport adverse drug reactions.

A federal judge tripled damages against the pharmacy benefits manager after finding it encouraged inflated Medicare drug claims and underpaid pharmacies.

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%.

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.

This episode of Pharma Pulse covers Catalent’s decision to cut 350 jobs at its Baltimore gene therapy site, new data showing rising adoption of digital tools for glycemic control in type 1 diabetes, and research linking severe childhood COVID-19 to heightened cardiovascular risk later in life.

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.

Payer-level reporting should do more than track performance—it must guide strategy, focus resources, and drive measurable brand impact.

This episode of Pharma Pulse covers a new collaboration to expand access to GLP-1 therapies via LillyDirect, Pfizer’s Phase III miss in sickle cell disease, and how patient portals are improving access to care while creating new workload challenges for providers.

The integration aims to simplify access to Zepbound for eligible members while providing comprehensive, whole-person care to support safe use, adherence, and management of related chronic health needs.

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.

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.

This episode of Pharma Pulse dives into Cardinal Health’s acquisition of Solaris Health to strengthen specialty services, how hospital networks are investing in centralized pharmacy hubs to improve efficiency and supply chain resilience, and new research linking GLP-1 drugs to potential optic nerve disorders.

In the first part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, explains how steep pharmaceutical import tariffs might affect costs at different points in the supply chain, why component pricing poses a bigger risk than active ingredients, and how insurers, distributors, and manufacturers may negotiate to shield patients from price increases.

Health systems across the United States are opening large-scale pharmacy service centers to streamline operations, improve inventory control, and ensure timely medication delivery amid drug shortages and rising costs.

This episode of Pharma Pulse covers Vinay Prasad’s return to lead the FDA’s biologics center after a brief resignation, new research on severe COVID-19 risks for childhood cancer survivors, and the strategies pharma companies are adopting to stay competitive amid escalating healthcare costs.

In the final part of his Pharma Commerce video interview, Philip Sclafani, PwC's pharmaceutical and life sciences lead, discusses operational and pricing strategies pharma executives can adopt to navigate sustained cost inflation, including supply chain optimization, payer collaboration, and value-based approaches to ensure patient access and affordability.

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.