Legal & Regulatory

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.

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.

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.

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

A federal judge tripled damages against the pharmacy benefits manager after finding it encouraged inflated Medicare drug claims and underpaid pharmacies.

Ron Lanton, partner, Lanton Law, explains that declining public trust and political support for vaccines could force pharmaceutical companies to rethink regulatory strategies and investment priorities in biologics and vaccine development.

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%.

Ron Lanton, Partner, Lanton Law, warns that shifting federal policies and ongoing lawsuits could create compliance challenges and operational risks that pharmaceutical supply chain leaders must closely monitor.

Amid the topsy-turvy developments in global trade, one message appears certain for pharma manufacturers: the escalating need to stockpile inventory in the US.

In the second part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, outlines how the impact of a steep pharmaceutical import tariff varies across raw materials, components, and finished products, along with why such a policy could incentivize companies to shift production to the US.

Two Labs’ Michael Rowe assesses the industry’s level of preparation, including challenges stakeholders have encountered along the way.

The directive calls for building a six-month Strategic Active Pharmaceutical Ingredients Reserve, updating the essential medicines list, and prioritizing US-made APIs.

As pharma drug pricing debates heat up, the 340B program faces mounting challenges from outdated regulations, duplicate discounts, and limited transparency.

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.

In the first part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, explains how steep pharmaceutical import tariffs might affect costs at different points in the supply chain, why component pricing poses a bigger risk than active ingredients, and how insurers, distributors, and manufacturers may negotiate to shield patients from price increases.

Why it’s time to act on passing key bills to boost access for millions.

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.

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.