Legal & Regulatory

At the conference’s milestone 20th anniversary event in Boston, experts unpacked the final stages of DSCSA implementation, highlighting pharmacy compliance challenges, state-level variability, and the role of technology in securing the pharmaceutical supply chain.

How is AI solving pharma's speed-to-market challenge?

Beginning Oct. 1, the US will impose a 100% tariff on branded and patented pharmaceutical imports unless manufacturers are actively building domestic production facilities, a move aimed at reshoring drug manufacturing.

Capturing insights from executives and industry experts on the biggest challenges shaping pharma today, from drug pricing pressures and access barriers to supply chain shifts, digital adoption, and evolving patient-centered care strategies.

The Generation Park site will create over 600 permanent jobs, support advanced small molecule production, and play a role in scaling orforglipron, Lilly’s first oral GLP-1 receptor agonist for obesity.

The South Korean pharma company’s US subsidiary is purchasing Eli Lilly’s Branchburg, NJ site to safeguard against potential tariffs. strengthen domestic production, and expands its biosimilar footprint.

New bipartisan legislation would give the FDA authority to modernize prescribing information, reducing waste while improving accuracy and patient care.

The pharmaceutical giant’s commitment includes a $1.2 billion investment in advanced facilities powered by AI and digital technology, strengthening biopharma manufacturing and clinical research across the United States.

The new Goochland County facility will serve as Lilly’s first fully integrated API and drug product site, focusing on antibody-drug conjugates, while creating thousands of jobs and strengthening domestic supply chains.

The South Korean CDMO has signed its second multi-billion-dollar contract in less than a year, even as shifting US trade policies and looming tariffs create challenges for global drugmakers.

Key points from our recent webinar on the President’s MFN order.

This episode of Pharma Pulse covers Gilead’s groundbreaking on a new technical development hub to accelerate biopharma innovation, the World Health Organization’s decision to add GLP-1s to its Essential Medicines List for diabetes, and new data showing high-dose influenza vaccines reduce heart risks in older adults.

The new 180,000-square-foot facility in Foster City anchors the company’s long-term $32 billion investment in domestic manufacturing and R&D.

This episode of Pharma Pulse covers President Trump’s appeal to the Supreme Court to preserve pharma tariffs, Sanofi’s 10% stock drop after Amlitelimab failed in Phase III, and new research showing how the COVID-19 pandemic reshaped pneumococcal mortality trends.

Following a federal appeals court decision that struck down much of his tariff authority under the International Emergency Economic Powers Act, President Trump is asking the Supreme Court to fast-track review.

The company is committing over half a billion dollars to build a state-of-the-art research hub in Thousand Oaks, CA, designed to accelerate next-generation therapeutics through advanced automation and collaboration.

This episode of Pharma Pulse covers the FDA’s approval of Sanofi’s Wayrilz for chronic immune thrombocytopenia, evidence that prescription-to-OTC switches of triptans improve migraine care access, and new FDA guidance waiving clinical efficacy studies for most monoclonal antibody biosimilars.

Lilly has temporarily halted UK shipments of Mounjaro until Sept. 1, when new list prices take effect.

This episode of Pharma Pulse covers Susan Monarez’s rejection of White House efforts to remove her as CDC director, new analysis on how long-lasting drug shortages expose systemic supply chain weaknesses, and the FDA’s approval of the first generic liraglutide for weight management.

With potential tariffs reaching 250% and new federal initiatives like SAPIR and most-favored nation pricing reshaping incentives, this explainer explores how major drugmakers are pouring billions into US facilities.

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.