REPORTING: Trump vs. Pharma?
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2025 Tariffs Barely Impact Europe's API Supply Chains
12/1/2025
When earlier this year the Trump administration began waving the specter of tariffs on drug substances and products entering the U.S., the biopharma world held its breath. European countries, as much as even China, felt the lack of oxygen. Would, for example, global sponsors leave European CDMOs to relocate their API production at contractors in the U.S.? Here's what we uncovered.
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Trump's Big Pharma Deals Drive CDMO Investments
1/14/2026
It is a remarkable twist of industry manipulations, government suasion, and economics. J&J cut a Most Favored Nation deal with the Trump administration that includes lowering prices – via TrumpRx.com – building more in the U.S., and (here’s the twist) investing in the U.S.-based facilities of a Japanese-owned CDMO. Got all that? Chief Editor Louis Garguilo offers analysis.
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Did Trump Just Create An Antibiotic Supply Chain In The U.S.?
9/11/2025
In 2022, we had headlines such as: FDA Declares Nationwide Amoxicillin Shortage. Now three years later a homegrown manufacturer — USAntibiotics of Bristol, Tennessee — says it can cover America’s demand under a new arrangement with two titans of distribution and retail: McKesson and Walmart. The other “titan” in the deal is President Trump. Chief Editor Louis Garguilo takes a nuanced look at this breaking news that again puts drug manufacturing on the front pages.
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The 15% Tariff: A Modest Jolt Or Deeper Disruption?
9/12/2025
Regarding the U.S. / E.U. “agreement” to a blanket 15% tariff on pharmaceuticals entering the former from the latter, Chief Editor Louis Garguilo zeroes in on potential effects of outsourcing active pharmaceutical ingredients (APIs). A 2025 analysis indicates 43% of branded pharmaceutical APIs used in U.S. prescriptions come from the E.U. Learn more about our predicament from a case study and closer look.
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What FDA's Complete Response Letters (CRL) Say About Outsourcing
9/2/2025
The FDA embraced "radical transparency” by publishing over 200 complete response letters (CRLs) for drug and biologics applications submitted between 2020 and 2024. Hooray for the FDA; good for drug developers hard at work today. Good for developers, writes Chief Editor Louis Garguilo, because he can identify patterns to help us outsource better.
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The FDA Was Darned Near Perfect, Right?
7/11/2025
Let's return to minutes before Donald Trump became president in January, to a time when the FDA was near perfect. That’s what one would assume today listening to those up in arms over the agency. Of course, the reality was quite different. Chief Editor Louis Garguilo helps regain perspective.
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Why CDMOs Are Leaving Small Molecules Behind
7/7/2025
It’s rare when a CDMO’s restructuring leads to thoughts about national health policy. But as Chief Editor Louis Garguilo wrote his recent editorial on Lonza’s decision to focus heavily on biologics, it brought to mind a government policy that may have contributed to the company’s restructuring. No, it's not tariffs.
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Tariffs On Toys … And API? Biopharma As The Next Battleground
6/3/2025
Outsourcing drug development and manufacturing is an attempt at purposeful action in a web of interdependent contingencies. The contingency top-of-mind today is President Trump’s tariff strategy, and global "negotiations" that have ushered in a supply-chain disquietude.
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Evolve Or Fade Away? Biotech's Outsourcing Moment In Trump's Tariff Tangle
5/22/2025
Ali Pashazadeh is "a deep thinker" that our Chief Editor visits with annually. Recently, he asked Pashazadeh to help us think through the evolving policies of the new U.S. presidential administration and the tariff turbulence, as they relate to a biotech's development and manufacturing outsourcing.
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Lilly's CEO Building On The Trump Agenda
5/12/2025
“We hadn’t built a new site in the U.S. in more than 40 years until the first set of Trump tax cuts, so we need to see those either extended or improved to support this,” Eli Lilly CEO David Ricks recently said, announcing — in Washington, DC — plans to invest $27 billion to build four new manufacturing plants in the U.S.