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BioWorld - Sunday, December 7, 2025
Home » Topics » Clinical

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Female doctor and patient
FT Global Pharma and Biotech Summit

Could restricting diversity efforts stall women’s health research?

Nov. 21, 2025
By Nuala Moran
No Comments
Recent progress in redressing the historical underfunding and neglect of women’s health could be undermined by the backlash against diversity, equity and inclusion (DEI) initiatives, according to executives participating in the FT Global Pharma and Biotech Summit 2025 in London Nov. 11-12.
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Multiple sclerosis-damaged myelin

Contineum’s PIPE-307 misses in midstage MS study

Nov. 21, 2025
By Lee Landenberger
No Comments
Contineum Therapeutics Inc.’s midstage study of its multiple sclerosis drug, PIPE-307, missed its primary and secondary endpoints, dropping the stock on Nov. 21. Top-line phase II results from the Vista study of the M1 receptor agonist PIPE-307 for treating relapsing-remitting multiple sclerosis saw no significant changes in binocular 2.5% low contrast letter acuity in the treatment arms, a key efficacy measure.
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Doctors examining lung scans

Taiho, Cullinan file rolling NDA on phase I/II zipalertinib data

Nov. 21, 2025
By Tamra Sami
No Comments
With phase I/II data in hand, Taiho Pharmaceutical Co. Ltd. and Cullinan Therapeutics Inc. began filing a rolling NDA to the U.S. FDA for accelerated approval of zipalertinib to treat patients with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations who previously received platinum-based chemotherapy.
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Eolife

Archeon’s Eolife increases survival rates after cardiac arrest

Nov. 20, 2025
By Shani Alexander
Archeon Medical SAS reported data from a study showing its real-time ventilation feedback device Eolife increased the survival rates of patients suffering out‑of‑hospital cardiac arrests. Furthermore, all the survivors in the Eolife group achieved full neurological recovery, three times the rate observed with conventional ventilation.
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Lymph nodes and lymphatic vessels

Protara sees Chugai blue sky in LMs as phase II data strong

Nov. 19, 2025
By Randy Osborne
No Comments
Success in Japan may further bolster Protara Therapeutics Inc. in its push with TARA-002 in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs), for which the New York-based firm disclosed interim results from an ongoing phase II trial.
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Illustration of sickle-cell and normal red blood cells

Agios planning sNDA on mixed sickle cell data for mitapivat

Nov. 19, 2025
By Jennifer Boggs
No Comments
“Our goal is that by the end of this call, you’ll share our conviction in the totality of the data.” So said Agios Pharmaceuticals Inc. CEO Brian Goff as the company reported top-line data from its 52-week Rise Up trial testing mitapivat in sickle cell disease showing the oral pyruvate kinase activator hit statistical significance on one of two primary endpoints and two of three key secondary endpoints.
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Jingsong Wang, CEO, Harbour Biomed
Cancer

Harbour Biomed launches AI-based antibody development platform

Nov. 19, 2025
By Tamra Sami
No Comments
Harbour Biomed is stepping up its antibody discovery process by using AI to develop innovative therapeutics. “We have done great through the traditional way of generating leads and designing molecules, but there’s a major gap as some therapeutics cannot reach the desired location or common targets,” Harbour Biomed founder, chairman and CEO Jingsong Wang told BioWorld.
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Doctor-patient consultation

J&J pushes to elevate patient voices in Asia

Nov. 18, 2025
By Tamra Sami
No Comments
Up to 77% of patients with non-small-cell lung cancer in Asia-Pacific rely almost entirely on their physicians to decide their treatment, even though 69% of physicians say they encourage shared decision-making. That disconnect remains one of the region’s biggest obstacles to improving outcomes, Anthony Elgamal, vice president of Oncology Asia Pacific at Johnson & Johnson Innovative Medicine, told BioWorld.
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FDA Approved stamp

Henlius, Organon win US FDA approval of first Perjeta biosimilar

Nov. 18, 2025
By Marian (YoonJee) Chu
No Comments
Shanghai Henlius Biotech Inc. and Organon & Co. announced Nov. 17 that the U.S. FDA cleared Poherdy (pertuzumab-dpzb) as the first and only interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc./Roche Holding AG).
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Jingsong Wang, CEO, Harbour Biomed

Harbour Biomed launches AI-based antibody development platform

Nov. 18, 2025
By Tamra Sami
No Comments
Harbour Biomed is stepping up its antibody discovery process by using AI to develop innovative therapeutics. “We have done great through the traditional way of generating leads and designing molecules, but there’s a major gap as some therapeutics cannot reach the desired location or common targets,” Harbour Biomed founder, chairman and CEO Jingsong Wang told BioWorld.
Read More
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