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BioWorld - Monday, December 29, 2025
Home » Topics » Clinical

Clinical
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Illustration of cancer on the esophagus

Jazz, Zymeworks unveil positive zanidatamab phase III data

Nov. 17, 2025
By Lee Landenberger
No Comments
A potentially $1.76 billion oncology deal created a little more than three years ago between partners Jazz Pharmaceuticals plc and Zymeworks Inc. now has a more solid direction. New and positive top-line results for the phase III Herizon-GEA-01 study of the HER2-targeted bispecific antibody zanidatamab in locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) moved the stock and expectations for both companies.
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Blood cells and bacteria

Ocean Dx sepsis test matches gold standard in early study

Nov. 17, 2025
By Annette Boyle
A rapid diagnostic test from Ocean Dx SAS delivered gold standard performance in a clinical evaluation that points to a potential shift in how sepsis is identified and treated. The assay, which detects more than 1,000 bacterial species directly from whole blood, returned 100% sensitivity and 100% specificity compared with reference blood cultures, with results reported in five hours. Further, the test tripled the number of infections identified.
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Single strand RNA

Backtrack to GalNAc: Korro AATD strategy Rewrite post-fizzle

Nov. 13, 2025
By Randy Osborne
No Comments
Korro Bio Inc.’s latest update on RNA editing prospect KRRO-110 may mean one less competitor in alpha-1 antitrypsin deficiency (AATD), and shares of the firm (NASDAQ:KRRO) closed Nov. 13 at $6.50, down $24.92, or 79%. As part of the third-quarter earnings report, Korro said KRRO-110 produced functional protein in AATD patients but fell short of projected levels of functional protein after a single administration.
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Mosquito

With malaria numbers rising, Novartis has phase III success

Nov. 13, 2025
By Lee Landenberger
No Comments
Phase III data from Novartis AG for the malaria treatment Ganlum (KLU-156) show it met the primary endpoint of noninferiority to the current standard of care, Coartem, a combination of artemether and lumefantrine. The results are a step to curbing a problem that has seen rising numbers in recent years.
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Doctor-patient consultation

J&J pushes to elevate patient voices in Asia

Nov. 13, 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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Female doctor and patient
FT Global Pharma and Biotech Summit

Could restricting diversity efforts stall women’s health research?

Nov. 12, 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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Man falling asleep in car

Alkermes’ alixorexton hits endpoints in narcolepsy phase II

Nov. 12, 2025
By Lee Landenberger
No Comments
Alkermes plc’s placebo-controlled phase II study of alixorexton in treating narcolepsy type 2 (NT2) hit its dual primary endpoints, producing statistically significant and clinically meaningful improvement in wakefulness and excessive daytime sleepiness. Alkermes said alixorexton is the first oral orexin 2 receptor agonist that has shown efficacy in a large phase II clinical trial in those with NT2.
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Liver anatomy with virus

Bluejay way: Positive phase II data for treating hepatitis D

Nov. 11, 2025
By Lee Landenberger
No Comments
Bluejay Therapeutics Inc.’s lead compound, the fully human monoclonal antibody brelovitug (BJT-778), produced positive virologic response data in the company’s phase II study of chronic hepatitis D virus, a condition with no approved treatment in the U.S.
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Art concept for bladder

Up the bladder ladder, Engene tweak means phase II bell rung

Nov. 11, 2025
By Randy Osborne
No Comments
Engene Holdings Inc.’s protocol amendment to its phase II trial with detalimogene voraplasmid in bladder cancer worked out in a big way, and shares of the firm closed Nov. 11 at $8.82, up $2.81, or 47%. Engene rolled out additional preliminary data from the pivotal cohort of the ongoing Legend study testing the nonviral gene therapy in high-risk, Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without concomitant papillary disease.
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Atrial fibrillation illustration
AHA Scientific Sessions

OCEAN study hints at no need for DOACs after afib ablation

Nov. 11, 2025
By Mark McCarty
Patients and their doctors are no fans of long-term use of direct oral anticoagulants (DOACs) after ablation treatment for atrial fibrillation, but three-year data from the OCEAN trial suggests that some patients may not need these DOACs after all, an outcome that qualifies as a crowd-pleaser for all but the makers of these pharmaceutical agents.
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