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BioWorld - Wednesday, March 25, 2026
Breaking News: Early FDA wins: Corcept’s Lifyorli, Denali’s AvlayahBreaking News: Trump administration impacts continue to roil the life sciences sector
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Regulatory actions for Sept. 17, 2025

Sep. 17, 2025
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Akeso, Corbus.
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Other news to note for Sept. 17, 2025

Sep. 17, 2025
Biopharma happenings, including deals and partnerships, and other news in brief: Adagene, Biocytogen, Exelixis, GSK, HCW, Kalexo, Mabwell, Novo Nordisk, Tubulis.
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In the clinic for Sept. 17, 2025

Sep. 17, 2025
Clinical updates, including data readouts and publications: Apollo, Areteia, Genmab, Moderna, Myrtelle, Novo Nordisk, Prota.
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Financings for Sept. 17, 2025

Sep. 17, 2025
Biopharmas raising money in public or private financings, including: Alligator, Altrixbio, Avidity, Biovaxys, Cantoni, Defence, Hoth, Kydo, Reunion, Revopsis, Silo.
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Appointments and advancements for Sept. 17, 2025

Sep. 17, 2025
New hires and promotions in the biopharma industry, including: Cumulus, Defence, Flagship, Imbria, Immuneering, Neovac, Ntx, Spyglass, Yellowstone.
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Monarez gives her side of how she was fired from the CDC

Sep. 17, 2025
By Mari Serebrov
No Comments
For enquiring minds that want to know, Susan Monarez laid out the details Sept. 17 of how she was fired as CDC director for the Senate Health, Education, Labor and Pensions Committee.
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Silhouette of person walking with a cane

Roivant, Priovant plan NDA on positive dermatomyositis data

Sep. 17, 2025
By Jennifer Boggs
No Comments
With positive phase III results in hand, Roivant Sciences Ltd. and Priovant Therapeutics Inc. anticipate an NDA filing in the first half of 2026, seeking approval for brepocitinib, a dual inhibitor of tyrosine kinase 2 and JAK1, in dermatomyositis, a rare autoimmune disease with limited treatment options.
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AI disease prediction illustration

New AI model simultaneously predicts risk of getting 1,000 diseases

Sep. 17, 2025
By Nuala Moran
No Comments
A new generative AI model trained on UK Biobank data can simultaneously forecast the risks and timing of developing over 1,000 different diseases a decade into the future. The developers applied similar algorithmic concepts to those used to develop large language models like ChatGPT and Gemini to build the model, using medical records from 402,799 participants in UK Biobank.
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Susan Monarez speaks at Senate HELP hearing

ACIP meeting cause for consternation at US Senate hearing

Sep. 17, 2025
By Mari Serebrov
No Comments
The Sept. 17 U.S. Senate Health, Education, Labor and Pensions Committee hearing on the CDC is throwing even more shade on the upcoming meeting of the agency’s reconstituted Advisory Committee for Immunization Practices (ACIP), which is expected to recommend changes to the childhood vaccine schedule.
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Close-up of eye with digital focus
Newco news

Ollin eyes next-gen ophthalmology space, launches with $100M

Sep. 17, 2025
By Jennifer Boggs
No Comments
To say the team at Ollin Biosciences Inc. has some experience in ophthalmology would be an understatement. The company, which emerged from stealth with $100 million in venture capital and two in-licensed assets with plans to add more, brings to the table years of expertise from work on blockbuster retinal disease drugs Lucentis (ranibizumab, Roche AG) and Vabysmo (faricimab, Roche AG).
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