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.
This episode of Pharma Pulse explores the FDA’s new proactive quality review initiative for drug manufacturing, GSK’s $370 million mRNA patent settlement with CureVac, and upcoming discussions between industry leaders and policymakers on strengthening US pharmaceutical innovation and supply chains.
In the seventh part of this roundtable discussion, key opinion leaders uncover how pharma companies can mitigate tariff impact through duty drawback programs and smart technology investments, without overreacting or overhauling manufacturing footprints unnecessarily.
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.
In an era of increasing regulatory complexity, life sciences organizations are modernizing GxP compliance through digital tools like eQMS, cloud platforms, and automated validation, while expert validation services remain essential for aligning these technologies with real-world workflows and inspection readiness.
This episode of Pharma Pulse covers Bayer’s $2.3 billion cost-cutting overhaul, promising Phase III results for Eli Lilly’s oral GLP-1 therapy orforglipron, and a pivotal court decision clearing the way for intensified competition in the high-growth obesity and diabetes treatment market.
In the third part of his Pharma Commerce video interview, Philip Sclafani, PwC's pharmaceutical and life sciences lead, explains how pharma companies can strategically evaluate AI investments across functions like R&D, pharmacovigilance, and supply chain, ensuring early automation gains and long-term value without intensifying short-term financial strain.
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.
This episode of Pharma Pulse examines how in-store pharmacies are evolving beyond prescriptions to deliver clinical services, nutrition support, and real-time education, bridging care gaps in pharmacy deserts across the United States.
In the final part of her Pharma Commerce video interview, Heather Zenk, Cencora’s president of US supply chain, outlines practical, cost-conscious strategies for reducing Scope 3 emissions in pharma supply chains, from smarter warehouse lighting and returnable cold chain packaging, to order consolidation and AI-enabled delivery optimization.
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 second part of his Pharma Commerce video interview, Philip Sclafani, PwC's pharmaceutical and life sciences lead, discusses how the pharmaceutical industry is balancing high-cost innovation, especially in obesity and metabolic disease, with payer demands for cost containment, highlighting the growing role of biosimilars and future generics in offsetting spend.
In the fifth 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 online weight loss company launches a $119 starter plan using low-dose semaglutide and behavioral coaching to improve access, reduce side effects, and support sustainable weight loss.
In the first part of his Pharma Commerce video interview, Philip Sclafani, PwC's pharmaceutical and life sciences lead, shares how he foresees the One Big Beautiful Bill Act reshaping prescription drug spending, and what strategies pharmaceutical companies adopt to mitigate its potential impact on innovation, R&D investment, and M&A activity.
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.
Amid the growing crisis of pharmacy deserts, these entities are tapping new avenues in care delivery, including the integration of clinical services, nutrition counseling, and real-time patient education.
In the third 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.
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.
Is the industry ready for the Aug. 1 deadline of when these levies go into effect?
In the second 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.
