PharmTech Weekly News Roundup — Week of September 29, 2025

In this PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage.

Collectively, the week’s coverage discusses the pharmaceutical industry’s recent developments and current regulatory landscape. Read on for recaps of each story we’ve covered.

White House, Pfizer Agree on MFN Pricing

Pfizer is the first pharmaceutical company to agree to the White House's most-favored-nation mandate, committing to lower its United States drug prices to match the lowest price among other developed nations.

FDA Draft Guidance’s Impact on Clinical, CMC Strategies

FDA has released draft guidance on its regenerative medicine advanced therapy designation, an expedited program for cell and gene therapies. The guidance allows for flexibility in clinical development but maintains stringent chemistry, manufacturing, and controls standards.

EMA to Include More Patient Perspectives

The European Medicines Agency has proposed using patient experience data to complement scientific data in regulatory decision-making. A draft reflection paper encourages developers to collect this real-world evidence throughout a drug's lifecycle.

FDA’s Remibrutinib Approval and the Future of BTK Inhibitors

FDA's approval of Novartis' remibrutinib for chronic spontaneous urticaria expands the Bruton's tyrosine kinase inhibitor drug class beyond oncology. This provides an oral alternative to injectable biologics for the immune-mediated condition.

‘Behind the Headlines’ Episode 26

In the latest “Behind the Headlines,” recent industry developments include clinical trial progress for multiple myeloma and breast cancer, Merck's FDA approval for a subcutaneous formulation of Keytruda, and Pfizer's acquisition of Metsera to enter the weight-loss drug market.

The Story of Nitrosamines

Since 2018, the discovery of nitrosamine impurities in widely used drugs has prompted significant regulatory action. Global regulators now require pharmaceutical companies to conduct rigorous risk assessments to mitigate these risks throughout the supply chain.

Advancing Radiopharmaceutical Development

Radiopharmaceuticals offer a precise, image-guided "theranostic" approach to cancer treatment, but development faces challenges including isotope supply and strict regulations. A new collaboration aims to create an integrated preclinical workflow to accelerate development.

How AI is Accelerating Pharmaceutical Development

Artificial intelligence (AI) and machine learning are being integrated into pharmaceutical workflows to screen compounds, predict drug properties in silico, and implement predictive controls in manufacturing. High-quality data and evolving regulatory frameworks are crucial for realizing AI's full potential.

What’s Reasonable for Agentic AI in Pharma? Part Two

In part two of a three-part series, there is an exploration of how agentic AI, which involves the autonomous coordination of goal-driven AI agents, can accelerate discovery by synthesizing information to generate novel hypotheses and has practical applications in pharmacovigilance and regulatory compliance.