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BioWorld - Monday, June 1, 2026
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Person holding pills and glass of water

CHMP recommends EU approval of Bayer’s Lynkuet for hot flashes

Sep. 19, 2025
By Nuala Moran
No Comments
Following the first approvals in the U.K., Canada, Australia and Switzerland, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is now recommending approval of Bayer AG’s Lynkuet (elinzanetant), a non-hormonal treatment for symptoms of menopause. The drug, the first dual neurokinin-1 and neurokinin-3 receptor antagonist, is for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes.
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Small-cell lung carcinoma cells under the microscope
Cancer

Rewiring SCLC: a neural path to therapy

Sep. 19, 2025
By Coia Dulsat
No Comments
Two back-to-back papers published in Nature on Sept. 10, 2025, shed new light on the unexpected role of neurons in shaping the evolution of small-cell lung cancer (SCLC). It’s already known that, in gliomas, cerebral cancer cells actively damage axons, contributing to tumor progression through direct neural disruption. Comparable nerve-tumor interactions have been reported in peripheral cancers, where tumor-induced nerve disruption promotes inflammation and an immunosuppressive microenvironment linked to immunotherapy resistance.
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ACIP delays vote on hep B vaccine, proposal not as bad as feared

Sep. 18, 2025
By Mari Serebrov
No Comments
Despite some expectations that the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) would dramatically change the childhood vaccine schedule for hepatitis B, the committee is poised to vote Sept. 19 on a much smaller change that would move the current birth dose to 1 month for infants born to mothers who test negative for hepatitis B.
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MASH dash speeds up as Roche acquires 89bio for up to $3.5B

Sep. 18, 2025
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A preview of the next edition of BioWorld, Sept. 18, 2025
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Regulatory actions for Sept. 18, 2025

Sep. 18, 2025
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Alteogen, Biocon, Eisai, Rgenta.
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Other news to note for Sept. 18, 2025

Sep. 18, 2025
Biopharma happenings, including deals and partnerships, and other news in brief: Arch, Frame Bio, Hillevax, Innate, Lipdro, Mercury Bio, Theratechnologies, Tonix, Xoma.
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In the clinic for Sept. 18, 2025

Sep. 18, 2025
Clinical updates, including data readouts and publications: Ascletis, Astrazeneca, Astria, Celldex, Cidara, Eli Lilly, Elicio, Hemostemix, Hightide, Incyte, Johnson & Johnson, Luxa, Merck, Navigator, Oruka, Palisade, Priovant, Regeneron, Roivant, Sagimet, Sanofi, Skyhawk, UCB.
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Financings for Sept. 18, 2025

Sep. 18, 2025
Biopharmas raising money in public or private financings, including: Arthex, Character, Cytokinetics, Enveric, Oncopeptides, Oruka.
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Appointments and advancements for Sept. 18, 2025

Sep. 18, 2025
New hires and promotions in the biopharma industry, including: Adarx, Character Biosciences, Invivyd, Quetzal, Rubedo.
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Close up of eye and vision test

Cornea field growing nicely; harvest ahead for Kala?

Sep. 18, 2025
By Randy Osborne
No Comments
As Wall Street awaits phase IIb data from Kala Bio Inc. with KPI-012 in persistent corneal epithelial defect, odds are being weighed for that candidate – and others in development – against the lone approved treatment used in a market already worth more than $1 billion.
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