Supply Chain/Logistics

Novartis expands its immunology pipeline with the Tourmaline acquisition and tests direct-to-patient model to reshape drug manufacturing strategies.

The 100% tariff on imported drugs will pressure biopharma companies to build manufacturing sites in the US or face significant costs.

The newly launched facility is located in The Woodlands, Texas, and will produce plasmid DNA as well as strengthen biopharma supply chains.

Nicole Hunter, head of Global WMArchitect at WMFTS, sat with the PharmTech Group at INTERPHEX 2025 to discuss the industry initiative around single-use assembly components that was prompted by the supply disruptions caused by the COVID-19 pandemic.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

Empowered by a $1.5 billion commitment from a major investor, Frontier Scientific Solutions has unveiled its plans for establishing a global free trade zone gateway intended for facilitating the life sciences supply chain using Wilmington International Airport in North Carolina.

TrakCel's OCELLOS, an IT platform, has been selected to orchestrate the administration of five out of seven autologous or matched allogenic cell therapy products approved or expected to be approved in 2024.

The US currently relies heavily on imports from China and other overseas nations for APIs needed to manufacture drug products of critical importance to US patients.

The BioMaP-Consortium includes members of the biopharmaceutical industry and supports BARDA.

The license holder should negotiate, educate, contract, and then oversee the transportation contractor, says Siegfried Schmitt, vice president, Technical at Parexel.

WHO provides a look at the world’s health as the agency turns 75.

Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.

Chris Spivey, editorial director for Pharmaceutical Technology and Biopharm International, spoke with Concetto Andrea Rizza, Marketing and Communications manager, ICE Pharma, on sustainability and ICE’s green approach at CPhI Barcelona 2023.

Taking a brief status check on the biologics supply chain and any impact on scale up operations.

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

Chris Spivey, editorial director, hosts a wide ranging discussion on the COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences and Dr. Tom Madden, President & CEO at Acuitas Therapeutics. Highlights include supply chain modalities, ensuring a fully trained manufacturing workforce, combining delivery with gene editing innovations, epigenetic approaches to modulate gene expression moving toward the clinic. We conclude with the huge potential for RNA expression of monoclonal antibodies and protein replacement applications.

Cold chain stakeholders continue to innovate with new technology development, the use of advanced modeling and analytics capabilities, and the pursuit of strategic partnerships.

The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.

Under the exclusive agreement, Hikma will commercialize products in Rakuten Medical’s pipeline for cancer treatment in the Middle East and North Africa region.

A proposed database includes key information about critical drugs, such as the country of origin and quantity, so supply chain weaknesses can be identified.

The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.

Cold chain stakeholders continue to innovate with new technology development, the use of advanced modeling and analytics capabilities, and the pursuit of strategic partnerships.

Problems continue despite actions by regulators to better prevent and address drug shortages.

Vaccine nationalism strengthens viruses and poses deadly risks for all involved.

Jane True, vice-president of mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead, Pfizer, shares her perspective on how mRNA will shift commercial models in the pharmaceutical industry.