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BioWorld - Friday, December 12, 2025
Home » Topics » Clinical

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More evidence piles up in favor of total arterial revascularization

Oct. 17, 2025
By Mark McCarty
Total arterial revascularization (TAR) might not be the most popular approach to coronary artery bypass grafting (CABG), but it is gaining in popularity according to a new study appearing in the Journal of the American College of Cardiology. The authors said that TAR provides superior mortality outcomes compared to bypass grafting that relies on both veins and arteries for graft materials, a finding that might suggest lower rates of downstream angioplasty and stenting.
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Mixed EMA news for Sanofi: Wayrilz yay, Rezurock nay

Oct. 17, 2025
By Nuala Moran
No Comments
There was a curate’s egg for Sanofi SA from this month’s meeting of the EMA’s Committee for Medicinal Products for Human Use, with a recommendation to approve one of the French pharma’s drugs – and the rejection of another.
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Herpes simplex virus

Aicuris to file pritelivir NDA on positive phase III data in herpes infections

Oct. 16, 2025
By Nuala Moran
No Comments
Aicuris Anti-Infective Cures AG is preparing to file for U.S. FDA approval after reporting positive phase III results for lead antiviral pritelivir in the healing of refractory herpes simplex virus lesions in immunocompromised patients.
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Shaky hands holding glass

Praxis soars on essential tremor phase III, preps for NDA

Oct. 16, 2025
By Karen Carey
No Comments
Success by nearly all measures with Praxis Precision Medicines Inc.’s essential tremor phase III candidate, ulixacaltamide, drove the company’s stock up significantly and provided solid data for an NDA filing planned for early 2026.
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Genedx’s Director of Laboratory Innovation Joe Devaney

Illumina's constellation tech a star in Genedx pilot

Oct. 15, 2025
By Annette Boyle
Genedx LLC partnered with Illumina Inc. to test whether Illumina's constellation map read technology could shed light on hard-to-detect variants that appear in rare diseases. Constellation met or exceeded the ability of other sequencing methods to detect variants implicated in multiple disorders and worked across a range of sample types, a study presented at the American Society for Human Genetics (ASHG) Annual Meeting in Boston on Oct. 15 found.
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Illustration of cancer tumor on pancreas

Astellas’ zolbetuximab misses pancreatic cancer phase II endpoint

Oct. 14, 2025
By Marian (YoonJee) Chu
No Comments
Astellas Pharma Inc. reported Oct. 14 that its CLDN18.2-targeting monoclonal antibody, zolbetuximab (Vyloy), did not meet the primary endpoint of overall survival in the phase II Gleam trial of patients with advanced pancreatic cancer.
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Cancer diagnostic illustration

BioFuture 2025: Varied paths for the cancer revolution

Oct. 14, 2025
By Lee Landenberger
No Comments
The importance of scalability, combination therapies, immunotherapies and speed in developing cancer drugs are paramount in creating a revolution in treating patients who often don’t have much hope, according to a panel of developers who spoke at the BioFuture conference in New York.
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Lungs

Tvardi drops dramatically on phase II rare lung disease data

Oct. 13, 2025
By Lee Landenberger
No Comments
Tvardi Therapeutics Inc. stock lost 83.9% of its value as investors took in poor preliminary results of the phase II study of its lead candidate for idiopathic pulmonary fibrosis (IPF). The company’s shares (NASDAQ:TVRD) closed at $6.69 each on Oct. 13.
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Cellfx

Pulse Biosciences’ Npulse successful in epicardial PFA

Oct. 10, 2025
By Annette Boyle
Pulse Biosciences Inc. presented late-breaking results from its successful first-in-human study of its nanosecond pulsed field ablation technology in treating atrial fibrillation at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, Denmark. The Hayward, Calif.-based company’s Npulse cardiac surgical system takes PFA technology into the cardiac surgery setting.
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Stomach and esophagus

Gastroesophageal push goes on; Jazz data soon

Oct. 10, 2025
By Randy Osborne
No Comments
A paper last month in the Journal of Clinical Oncology reported on the pooled analysis of data showing that the use of neoadjuvant immune checkpoint inhibitors work better than the frequently used FLOT regimen (fluorouracil, leucovorin, oxaliplatin and docetaxel) in certain gastroesophageal adenocarcinoma (GEA) cancers. But there’s plenty more coming down the pike, even as scientific knowledge about the disease advances.
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