Manufacturing & Packaging

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.

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

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.

The company joins a wave of global pharma companies reshoring operations to strengthen the US supply chain and meet patient needs through domestic innovation and capacity.

In the second part of this roundtable discussion, a panel of key opinion leaders dive into the key risk factors impacting the pharma manufacturing space, and how the industry should aim to address them.

The collaborative research initiative will be focused on advancing approaches to enhance the therapeutic efficacy of regulatory T cells and tumor-infiltrating lymphocytes.

In the second part of his Pharma Commerce video interview, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, explains how recent shifts in FDA leadership, funding constraints, and evolving CMC standards have each played a role in this process.

In the first part of his Pharma Commerce video interview, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, discusses both the successes and challenges in commercializing cell and gene therapies.

The new system meets the increasing demand for faster, more precise processes that enhance quality while boosting efficiency in the pharma manufacturing industry.

The 200,000 square-foot Madison, WI facility will serve as the flagship location, with capabilities for future growth.

The biopharma company—whose US headquarters is in Atlanta—will be building a new biologics manufacturing facility in a city to be named at a later date.

In the first part of her Pharma Commerce video interview, Kirsten Newquist, Identiv’s CEO, defines the term, and explains how it is helping to combat the growing threat of counterfeit drugs in today’s global supply chain.

The installation of the new vial, syringe, and cartridge line is expected to take place throughout the coming year.

In the third part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, shares the challenges that stakeholders are encountering, along with a possible change to the national drug code that could be on the way.

The track-and-trace systems provider expands its life sciences portfolio by integrating the high-speed, adaptable ETF-300 precision labeler through a partnership that brings Industry 4.0-ready capabilities, advanced printing tech, and enhanced data security to pharmaceutical packaging.

In the first part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, shares his overall thoughts on this year’s DMC.

The move bolsters the CDMO’s commitment to cell and gene therapy by incorporating advanced manufacturing and fill-finish capabilities.

As the adoption of biologics rises, demand for home healthcare grows, and conditions like diabetes and autoimmune disorders become more prevalent, self-injectables are here to stay.

The company’s branded form of nadofaragene firadenovec-vncg will also be produced at a hub in Parsippany, NJ.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Paul Levesque, CEO of Theratechnologies, explains what the mindset be for companies who are just starting the reshoring process.

The deal for the San Diego hub provides the CDMO with its first-ever North American manufacturing location for prefilled syringes and cartridges.

The new firm—with 13 manufacturing facilities spanning France, Sweden, and Spain—will support the pharma supply chain through to commercialization.

Vendors are growing, and product and service offerings are expanding.

When delays and disruptions threaten not only product integrity but patient well-being, thorough risk assessment and mitigation are essential.

Exploring the importance of contract development and manufacturing organizations in advancing the latest technology for effective delivery of temperature-sensitive medicines.

Taking stock of today's gains and tomorrow's potential for generative artificial intelligence in reshaping the industry.

New facility is expected to serve as a global hub for accelerating the development of next-generation antibody-drug conjugates for the treatment of cancer.