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PharmTech Weekly News Roundup — Week of September 22, 2025

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Your weekly news hub for biopharma trends, FDA regulations, M&A deals, supply chain insights, drug development innovations from BIO-Europe, and more.

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.

How 100% Pharma Tariffs Impact Domestic Manufacturing, Supply Chains

A new trade policy from US President Donald Trump imposes a 100% tariff on imported branded pharmaceuticals, effective Oct. 1, 2025. Companies can avoid it by building United States manufacturing facilities, a move that has already prompted billions in investments.

Acetaminophen and Autism: Impacts of WH Statement

The White House has discouraged acetaminophen use during pregnancy, citing studies suggesting a link to autism. While some medical groups find the evidence inconclusive, the situation highlights the vulnerability of established drugs to new scrutiny.

Global Biopharma Leaders to Shape Industry Outlook

BIO-Europe 2025 will gather over 5700 attendees to discuss strategic partnerships for drug development. Sessions will cover Europe's competitiveness, the investment landscape, and challenges in creating rare disease therapies.

New ‘Ask the Expert’ Video

Experts are addressing the mandatory lifelong collection of real-world evidence for marketed drugs to monitor side effects. Another concern is supply chain security, with theft during transport necessitating thorough risk assessments.

Pfizer-Metsera Deal Underscores Development, Manufacturing Innovation

Pfizer will acquire Metsera for approximately $4.9 billion, enhancing its obesity drug pipeline with differentiated candidates. The deal highlights trends focused on clinical differentiation and manufacturing scalability.

What’s Reasonable to Expect from Agentic AI in Pharma?

Agentic artificial intelligence (AI), the autonomous coordination of AI "agents," could reinvent R&D processes beyond simple automation. Its successful implementation requires robust data governance and interoperability.

European Commission Streamlines Drug Lifecyle Management

The European Commission published new guidelines, effective Jan. 15, 2026, to streamline the lifecycle management of drug marketing authorizations by classifying variations based on risk.

‘Behind the Headlines’ Episode 25

The latest episode of “Behind the Headlines” discussed major portfolio management moves, including the Pfizer-Metsera deal and acquisitions by Novartis. It also covered the expansion of cell and gene therapies beyond oncology.

Converging Fronts of Cancer Treatments

Oncology advancements include plans for a £1 billion (US$1.34 billion) cancer research center in London and progress in emerging treatments like tumor-infiltrating lymphocytes. FDA also released draft guidance for developing radiopharmaceuticals.

‘Two-Minute Mysteries’ Episode 1

In the premiere of “Two-Minute Mysteries,” in a manufacturing case, a lab saw low readings in a dissolution test. An investigation found vibrations from a nearby refrigerator caused powder to fall from the testing basket, preventing proper dissolution.

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