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Celldex’s urticaria candidate impresses in post-treatment findings

June 13, 2025
By Jennifer Boggs
No Comments
Celldex Inc.’s KIT inhibitor, barzolvolimab, which hit its phase II endpoints in late 2023, kicking off phase III development in chronic spontaneous urticaria, offered up some impressive long-term findings at the EAACI Congress 2025, including complete responses in patients for as long as seven months after the cessation of therapy, which analysts said could position the drug as a potentially best-in-class option.
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Art concept for bladder

Zusduri flurry ends; ‘set up’ at ODAC, Urogen prevails with FDA

June 13, 2025
By Randy Osborne
No Comments
During a conference call after the U.S. FDA approval of Zusduri (mitomycin), Urogen Pharma Ltd. CEO Liz Barrett offered candid observations about a “roller-coaster ride” sparked by a mixed-outcome advisory panel meeting held May 21. Zusduri is designed to treat recurrent low-grade, intermediate-risk, non-muscle invasive bladder cancer.
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Free access to BioWorld coronavirus articles

June 13, 2025
The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus pandemic. They are available for free with registration. Note that we have added three critical tables, which are continuously updated:

Vaccines and therapeutics in development
Diagnostics with U.S. FDA emergency use authorization
Clinical trials of biopharma products affected by COVID-19
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Biontech’s $1.25B Curevac buyout removes mRNA lawsuit uncertainty

June 12, 2025
A preview of the next edition of BioWorld, June 12, 2025
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Regulatory actions for June 12, 2025

June 12, 2025
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Azurity, Cantargia, Capricor, Chemomab, Kelun-Biotech, Radiopharm.
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Other news to note for June 12, 2025

June 12, 2025
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Chiesi, Daewoong, Eli Lilly, Evofem, Intelgenx, Juvena, Key2brain, Qlaris, Salipro, Windtree.
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In the clinic for June 12, 2025

June 12, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Argenx, Bioinvent, Bristol Myers Squibb, Cabaletta, Cellectar, Fate, Immunewalk Therapeutics, Intensity, Johnson & Johnson, Kelun-Biotech, Memo, Novavax, Pacira, TC Biopharm, Vaxart.
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Financings for June 12, 2025

June 12, 2025
Biopharmas raising money in public or private financings, including: Blue Water, Cogent, Mezzion, Pharmazz, Slingshot, Sun, Tempest.
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Appointments and advancements for June 12, 2025

June 12, 2025
New hires and promotions in the biopharma industry, including: Celularity, Instil, Inventiva, J&J, Oncolytics, Pasithea, Uniqure, Xilio.
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Newco news

Startup Elkedonia raises €11M to advance neuroplastogen in depression

June 12, 2025
By Nuala Moran
No Comments
Newco Elkedonia SAS has raised €11 million (US$12.7 million) in a seed round, which will fund it to take a potentially first-in-class ELK-1 inhibitor into the clinic in the treatment of refractory depression. ELK-1 plays a pivotal role in neuroplasticity and in reward circuits in the brain, which when disrupted can lead to depression, addiction and post-traumatic stress disorder.
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