Logistics & Transportation

Articles

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.

FDA Greenlights New COVID Vaccines, Sets Eligibility Limits

. He can be reached at nsaraceno@mjhlifesciences.com.

Videos

In the fourth part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, cautions that stockpiling to offset tariffs could backfire for pharma companies, leading to expired inventory, higher waste, and costly trade-offs, unless renegotiation strategies are pursued.

Pharma Supply Chain Faces Risks of Tariffs Driving Excess Inventory

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.

DSCSA Distributor Exemption Ends, Marking Major Milestone in Pharma Supply Chain Security

Podcasts

This episode of Pharma Pulse covers the FDA’s new daily adverse event reporting initiative, the CDC’s appointment of an mRNA vaccine critic to lead its COVID-19 immunization workgroup, and Genentech’s $700 million investment in a North Carolina biologics facility.

Pharma Pulse: FDA Boosts Transparency, CDC Appoints mRNA Critic, and Genentech Invests $700M in US Manufacturing

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.

Genentech Breaks Ground on $700M North Carolina Manufacturing Facility

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.

Pharma Pulse: Novo Nordisk Plant Faces FDA Scrutiny, Off-Label GLP-1 Use Grows, and AbbVie Expands Psychiatry Pipeline

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. 

Novo Nordisk’s Indiana Plant Flagged by FDA for Contamination and Safety Lapses

Addressing the most common concerns surrounding the legislation intended to establish interoperability within the pharma supply chain. 

Pharma Pulse: Pharma Tariffs Take Shape, J&J Invests $2 Billion in US Manufacturing, and New EHR Rule Targets Prior Authorization

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%.

Manufacturing & Packaging