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Pregnant woman

EMA: New clinical guideline includes pregnant, breastfeeding patients

June 5, 2025
By Nuala Moran
No Comments
The EMA has issued a new guideline on how to include and/or retain pregnant and breastfeeding women in clinical trials, in a move that it says “marks a change in the paradigm.” The aim is to ensure that trial sponsors generate robust clinical data in these populations.
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Flag of South Korea with skyscrapers in the background

Korea pharma exports rise to quarterly high of $2.5B in Q1

June 4, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of implant products to both China and the U.S.
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US trade court blocks emergency tariffs, but threat remains

May 29, 2025
By Mari Serebrov
No Comments
A court decision blocking President Donald Trump’s reciprocal and trafficking tariffs was hardly a day old before the U.S. Court of Appeals for the Federal Circuit stepped in late May 29 to grant a temporary stay while it considers the administration’s appeal. The stay adds further uncertainty to the path ahead for drug and device companies.
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USTR begins search for biopharma R&D ‘freeloaders’

May 28, 2025
No Comments
The U.S. Trade Representative (USTR) is asking for help in its search for “freeloaders” that refuse to shoulder their share of the cost of biopharma R&D.
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Trump tariff EO signing

South Korea urges US to exempt pharma, allies from tariffs

May 13, 2025
By Marian (YoonJee) Chu
No Comments
South Korean government and biopharmaceutical industry representatives urged American policymakers May 7 to refrain from imposing tariffs on pharmaceutical imports, and to spare allies if pharma tariffs are deemed necessary. Both Korea’s Ministry of Health and Welfare on May 4 and the Korea Biotechnology Industry Organization on May 6 submitted comments to the U.S. Department of Commerce in response to its ongoing investigation of pharmaceutical imports.
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Jorge A. Goldstein at Bio Korea 2025
Bio Korea 2025

US legal issues to track in pharma, biotech

May 13, 2025
By Marian (YoonJee) Chu
No Comments
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
Read More
Illustration of Won currency, graph, up arrows

Korea pharma stocks rally; Celltrion welcomes US drug pricing

May 13, 2025
By Marian (YoonJee) Chu
No Comments
Korean pharmaceutical stocks rose across the board May 13, a day after U.S. President Donald Trump signed off on the most favored nation executive order, a drug pricing policy expected to benefit biosimilar makers in the U.S., according to Celltrion Inc.
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Drug capsule and dollar sign

Little bite from voluntary most-favored nation Rx pricing order

May 12, 2025
By Mari Serebrov
No Comments
After a week of hype, the most-favored nation (MFN) drug pricing executive order (EO) U.S. President Donald Trump signed May 12 has a lot of bark but little bite, as one analyst put it. Brian Abrahams, head of global healthcare research at RBC Capital Markets LLC, said the EO is unlikely to rattle the biopharma sector, even though it lacked the certainty to completely remove the MFN overhang. “We see reason for relief and, alongside improving FDA clarity and limited tariff risk, expect biopharma to be viewed as increasingly investable,” Abrahams said.
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Global market charts

Pause on tariffs could boost med-tech earnings

May 12, 2025
By Annette Boyle
The long-term status of the trade dispute with China remains unclear, but a 90-day reduction in stratospheric tariffs imposed by the U.S. and China on their respective products provides breathing room for the med-tech companies predicting the hardest hit from the original levels.
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Jorge A. Goldstein at Bio Korea 2025

US legal issues to track in pharma, biotech: Bio Korea 2025

May 8, 2025
By Marian (YoonJee) Chu
No Comments
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
Read More
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