The Trump administration is expected to announce tariffs on pharmaceuticals "in the next month or two," an official said. The European Commission has approved Eisai and Biogen's Leqembi in Alzheimer's disease. Kyowa Kirin has finished the build-out of a Japanese biologics plant. And more.
The Trump administration has launched what’s known as a Section 232 investigation, looking into the national security effects of pharmaceutical imports. Findings from the probe could support tariffs on drugs, which Commerce Secretary Howard Lutnick said will come “in the next month or two.” The Indian Pharmaceutical Alliance warned that generic manufacturers, which are already operating on “razor-thin margins,” can’t bear large tariffs.
2. Eisai, Biogen's Alzheimer's med Leqembi wins long-awaited European approval
After months of back and forth, Eisai and Biogen’s Leqembi has won the European Commission’s authorization in Alzheimer’s disease. The indication covers certain early-stage patients with mild cognitive impairment. In Europe, the drug's use is restricted to those who have one or no copies of the ApoE4 gene and who have amyloid beta plaques in their brain.
Kyowa Kirin has finished the construction of a new drug substance manufacturing facility at its site in Takasaki, Japan. The 16.8 billion Japanese yen ($118 million) plant will be used to produce investigational biologics for early-stage development. The site also serves as a training facility to help fill Japan’s gap in experienced biopharma production engineers.
4. Biocon Biologics lines up US Eylea biosim launch in '26 (Regulatory tracker)
Biocon Biologics has reached a deal with Regeneron on the company’s Eylea biosimilar, Yesafili. Approved by the FDA last year, the interchangeable biosimilar can be launched in the U.S. in the second half of 2026 or earlier under certain conditions. Given the settlement, the two firms have moved to dismiss their pending litigations on the subject.
5. Daiichi Sankyo inks RNA-targeted neurodegenerative disease deal with Wayfinder (release)
Daiichi Sankyo has penned a collaboration with Wayfinder Biosciences to develop RNA-targeting small molecules for a neurodegeneration target. Seattle-based Wayfinder says its platform enables quantitative insights into the binding of small molecules to RNA and their selectivity and function. Financial details were not disclosed.
6. Haleon takes full control of famed Chinese consumer health joint venture (Reuters)
Haleon paid about 1.62 billion Chinese yuan ($220 million) to obtain the remaining 12% stake in the Chinese joint venture Tianjin TSKF Pharmaceutical. Formed in the 1980s by Smith, Kline & French and Tianjin Pharmaceutical, the consumer health firm marked one of the first foreign-backed drugmakers to enter China. The company is a household name with popular OTC brands such as the Fenbid line of ibuprofen products, and it generated 2024 revenue of 3.56 billion yuan ($490 million).
Other News of Note:
7. Aurobindo gets Form 483 scolding from FDA at North Carolina inhaler plant
8. Daiichi Sankyo celebrates its roots and blooming future at DC cherry blossom festival
9. After 5-year delay, CMG Pharma wins FDA nod for oral schizophrenia drug (Korea Biomedical Review)