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BioWorld - Sunday, December 21, 2025
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Regulatory actions for July 15, 2025

July 15, 2025
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atara, Bayer, Biodexa, Corcept, GSK, Nanoscope,Ultragenyx, Valneva, Zenith.
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Other news to note for July 15, 2025

July 15, 2025
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boehringer, Essa, Leo, Simris, Xeno.
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Financings for July 15, 2025

July 15, 2025
Biopharmas raising money in public or private financings, including: OS Therapies.
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Appointments and advancements for July 15, 2025

July 15, 2025
New hires and promotions in the biopharma industry, including: Bonus Biogroup, Disc, Gero, Recludix, Uniquity.
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Amyloid plaques on nerve cell

Illimis $42M series B to spur study of Aβ-clearing fusion protein

July 15, 2025
By Marian (YoonJee) Chu
No Comments
Illimis Therapeutics Inc. raised ₩58 billion (US$42 million) in a series B financing round. The funds will support development of ILM-01, its lead bispecific fusion protein candidate, into preclinical development for Alzheimer’s disease by the second half of 2025, along with the company’s neuroimmunology portfolio.
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3D rendering of CAR T therapy in cell

Imugene’s allogeneic CD19 CAR T sees 75% response rate

July 15, 2025
By Tamra Sami
No Comments
Immuno-oncology company Imugene Ltd.’s allogeneic, off-the-shelf CD19 CAR T, azercabtagene zapreleucel (azer-cel), has resulted in seven complete responses and three partial responses in a phase Ib trial in relapsed diffuse large B-cell lymphoma patients, according to an interim analysis. The responses to date show a 75% overall response rate.
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Illustration of kidney with DNA structures
Newco news

Renasant launches with $54.5M to develop drugs for a genetic kidney disease

July 15, 2025
By Brian Orelli
No Comments
Launched out of 5AM Ventures’ 4:59 Initiative, Renasant Bio Inc. has secured $54.5 million in seed funding to support development of treatments for autosomal dominant polycystic kidney disease (ADPKD), a genetic disease caused by mutations in the PKD1 and PKD2 genes, which encode polycystin proteins PC1 and PC2 that come together to form a calcium ion channel vital for kidney function.
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Hengrui/Kailera obesity asset delivers solid weight loss in phase III

July 15, 2025
By Karen Carey
No Comments
A glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptor dual agonist developed by Jiangsu Hengrui Pharmaceuticals Co. Ltd. and licensed by Kailera Therapeutics Inc. has shown a mean weight loss of 19.2% at the 6-mg dose with no plateau over 48 weeks in a phase III trial conducted in China.
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Multiple myeloma illustration

Adcom briefing docs eye toxicity of GSK’s Blenrep

July 15, 2025
By Randy Osborne
No Comments
As the July 23 PDUFA date nears for GSK plc’s Blenrep (belantamab mafodotin), the U.S. FDA’s Oncologic Drugs Advisory Committee will decide July 17 on whether available data justify the return to market of the antibody-drug conjugate as a therapy for relapsed/refractory multiple myeloma, and briefing documents made public ahead of the meeting laid out the issues.
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Brain and neural networks
Biomarkers

Proteomics finds surprise commonalities as well as differences in neurodegenerative diseases

July 15, 2025
By Nuala Moran
No Comments
The switch will be flicked today to make the world’s largest dementia-related proteomics dataset freely available to researchers, at the same time as members of the consortium which compiled it publish the proteomics signatures of major neurodegenerative diseases that they uncovered in a first trawl of the data.
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