Legal & Regulatory

As AI adoption accelerates across life sciences, Shawn Opatka, VP and GM of Honeywell Life Sciences, and Linda Malek, JD, partner at Crowell & Moring, discuss how regulatory expectations and federal initiatives—like the White House AI Action Plan—are shaping the technology’s future role in pharma quality, traceability, and healthcare systems.

The investment will establish a new hub overseeing contract manufacturing across India and expand Lilly’s global supply of medicines for Alzheimer’s, diabetes, obesity, and cancer, amid shifting US trade and tariff policies.

Advice for pharma distributors and dispensers on what they should do now in order to solidify a secure supply chain.

Following Congress’ failure to pass funding measures, FDA announced it will continue only essential public health and safety functions. This amid a pause on imposing 100% tariff rates.

How cell and gene therapy developers can lessen the chances of receiving FDA complete response letters through the use of proactive chemistry, manufacturing, and controls strategies.

Dave Malenfant, healthcare supply chain expert, discusses the ramifications of a 100% tariff on branded and patented drugs entering the US.

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.

Ullrich Mayeski, community engagement director of health with GS1 US, explains how with over a decade of collaboration, manufacturers and distributors are largely prepared for DSCSA compliance. The remaining challenge lies in ensuring consistent readiness across dispensers, while maintaining open communication throughout the supply chain.

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.

Ullrich Mayeski, community engagement director of health with GS1 US, describes the organization’s EPCIS standard for meeting DSCSA requirements while underscoring that true supply chain success depends on robust data quality practices, clear procedures, and cross-team accountability to ensure patients receive their medications without disruption.

Industry leaders—from manufacturers, distributors, and dispensers—reported increased preparedness for compliance, with discussions shifting toward exception management, governance, and enforcement readiness, note Ullrich Mayeski of GS1 US and Mark Karhoff of Ten Count Consulting.

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.

In the final part of his Pharma Commerce video interview, Diogo Rau, executive vice president and chief information and digital officer for Eli Lilly and Company, focuses on physician demand, global momentum, and how US legislation can help the industry finally move beyond paper.

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.