Manufacturing & Packaging

FDA approves COVID-19 vaccines from Moderna, Pfizer-BioNTech, and Novavax targeting the LP.8.1 sublineage of SARS-CoV-2, with eligibility limited to adults aged 65 years and older and those with underlying medical conditions that place them with a high risk for severe disease.

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.

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.

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.

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.

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.

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.

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.

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.

With 14 new lawsuits filed and 132 total complaints across 40 states, Novo Nordisk is intensifying efforts to protect patients from unapproved compounded semaglutide products by targeting pharmacies, telehealth providers, and deceptive marketing practices that compromise safety, mislead consumers, and violate FDA regulations.

In the fourth part of her Pharma Commerce video interview, Heather Zenk, Cencora’s president of US supply chain, explores how public-private collaboration, smarter sourcing strategies, and long-term manufacturer support are helping to fortify pharmaceutical supply chains against future crises.

The Spain-based CDMO strengthens its North American presence and capabilities through its purchase, while also acquiring a new rare disease treatment from Sanofi one month prior.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Nate Chenenko, principal with Ducker Carlisle, explains that as regulatory frameworks tighten across Europe and the United States, and customer preferences lean greener, pharma logistics leaders must balance compliance, cost, and innovation to meet mounting sustainability demands.

The letters demand US drug prices match or undercut global lows, triggering a 60-day compliance timeline, and prompting strategic responses from players in the space, including Celltrion.

Regeneron has received a second complete response letter from the FDA for odronextamab and anticipates delays for Eylea HD due to inspection findings at a Catalent manufacturing site, despite continued strong revenue growth and pipeline momentum.

In the fourth part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Nate Chenenko, principal with Ducker Carlisle, shares best practices for reducing greenhouse gas emissions across distribution channels without disrupting supply chain efficiency.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Nate Chenenko, principal with Ducker Carlisle details how manufacturers can overcome the data gaps from suppliers and third parties when aiming for sustainability certifications or ESG reporting compliance.

In the first part of her Pharma Commerce video interview, Heather Zenk, Cencora’s president of US supply chain, explores how public-private collaboration, smarter sourcing strategies, and long-term manufacturer support are helping to fortify pharmaceutical supply chains against future crises.

The new deal imposes 15% tariffs on most EU exports, including pharmaceuticals.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Nate Chenenko, principal with Ducker Carlisle, dives into the metrics pharma companies can track today in order to measure distribution-related sustainability performance.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Nate Chenenko, principal with Ducker Carlisle, explains the meaning behind Scope 3 emissions, including why they pose such a challenge for pharma manufacturers.

These innovations are revolutionizing pharmaceutical packaging by enhancing drug safety, combating counterfeiting, ensuring regulatory compliance, and improving patient adherence across the supply chain.

In the third part of his Pharma Commerce video interview, Murray Aitken, executive director, IQVIA Institute for Human Data Science, explains the strategies that manufacturers should adopt to balance investment in innovation with lifecycle management.

Cellular Origins, CGT Catapult, and Resolution Therapeutics partner up to design a fully automated, scalable CGT manufacturing solution, with the goal of accelerating patient access to cell therapies.