Legal & Regulatory

The fallout is impacting partners Scholar Rock and Regeneron, both of whom have pending regulatory applications tied to the facility.

The global generics maker’s new Florida site will produce more than 25 critical respiratory medicines, create over 200 jobs, and reinforce domestic manufacturing and drug security.

The new Albemarle County site—reportedly the largest investment in AstraZeneca’s history—will focus on API and ADC production, create 3,600 jobs, while strengthening US pharma supply chain resilience.

The appellate court upheld Medicare’s authority to negotiate lower drug prices under the Inflation Reduction Act, following similar rulings against AstraZeneca, Bristol Myers Squibb, and Novartis.

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.

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.

This episode of Pharma Pulse covers the FDA’s review of a possible link between prenatal acetaminophen use and autism, GSK’s supplemental new drug application to update leucovorin labeling, and Celltrion’s acquisition of an Eli Lilly production facility to expand biologics manufacturing capacity.

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.

This episode of Pharma Pulse covers the CDC’s decision to postpone changes to Hepatitis B vaccine guidance, new research showing value-based care improves visit frequency and consistency for seniors, and Takeda’s partnership with VELA to launch wind-powered transport for medicines.

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.