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Medical Devices & Diagnostics

Can Roivios’ JuxtaFlow device redefine kidney support in heart failure and cardiac surgery patients?

Roivios Ltd., a clinical-stage medical device developer, has announced encouraging results from its first-in-human study of the JuxtaFlow Renal Assist Device, a technology designed to support fluid removal and renal function in patients with diuretic-resistant cardiorenal syndrome and acute decompensated heart failure. The results, published in the ASAIO Journal, showed that JuxtaFlow significantly improved both

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Medical Devices & Diagnostics

How KVP International’s SafePath-IVD buy could reshape veterinary and human diagnostics

KVP International has announced the acquisition of SafePath Laboratories and IVD Research, a diagnostics manufacturer and contract development and manufacturing organization (CDMO) provider headquartered in Carlsbad, California. With this move, KVP International aims to strengthen its footprint in veterinary diagnostics while unlocking the potential to expand into human health markets. This acquisition provides KVP International

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Medical Devices & Diagnostics

Can Sanyou Biopharmaceuticals and KanryBio Biotechnology disrupt the global companion diagnostics market?

Sanyou Biopharmaceuticals (Shanghai) Co., Ltd. and Wenzhou KanryBio Biotechnology Co., Ltd. have entered into a strategic collaboration focused on co-developing high-value reagents and products for biomarker assay kits. Announced on December 10, 2025, this partnership aims to combine Sanyou Biopharmaceuticals’ global leadership in AI-driven molecular discovery with KanryBio Biotechnology’s capabilities in kit product development and

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Pharma & Biotech

Could AHB-137 set a new benchmark for HBV cure rates? Insights from AusperBio’s 24-week monotherapy trial

AusperBio Therapeutics, Inc. announced that its lead investigational product, AHB-137, achieved a 30% functional cure rate as a 24-week monotherapy in HBeAg-negative chronic hepatitis B patients already on stable nucleos(t)ide analogue therapy. The data, presented at HEP-DART 2025, showed that patients with baseline HBsAg 100–1,000 IU/mL reached this endpoint at Week 72 in the company’s

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Pharma & Biotech

Could NanOlogy’s targeted intratumoral cisplatin rewrite the outlook for DIPG in children?

NanOlogy, LLC, a Texas-based clinical-stage oncology company, has announced the launch of a drug development program focused on diffuse intrinsic pontine glioma, known as DIPG, a universally fatal pediatric brainstem tumor. The company is advancing Large Surface Area Microparticle Cisplatin, or LSAM-cisplatin, designed for stereotactic intratumoral administration in children. Investigational New Drug–enabling studies are underway,

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Pharma & Biotech

Can Eli Lilly’s Inluriyo outpace rivals in ESR1-mutated breast cancer after EMBER-3?

Eli Lilly and Company has released updated Phase 3 EMBER-3 results for Inluriyo, also known as imlunestrant, its oral estrogen receptor antagonist, in patients with estrogen receptor-positive and human epidermal growth factor receptor 2–negative advanced or metastatic breast cancer. These new data, presented at the 2025 San Antonio Breast Cancer Symposium and published in Annals

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Medical Devices & Diagnostics

Will the TricValve pivotal trial finally solve the unmet needs in severe tricuspid regurgitation?

P&F Products and Features GmbH, the Austria-based cardiovascular device innovator, has secured approval from the U.S. Food and Drug Administration to initiate the TRICAV II pivotal clinical trial. The study will evaluate the TricValve Transcatheter Bicaval Valve System for severe tricuspid regurgitation, aiming to provide a minimally invasive option for patients who currently have no

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Pharma & Biotech

FDA approval gives J&J’s AKEEGA a first-mover edge in BRCA2-mutated metastatic prostate cancer

Johnson & Johnson (J&J) announced on December 12, 2025, that the U.S. Food and Drug Administration approved AKEEGA, a dual-action tablet combining niraparib and abiraterone acetate, alongside prednisone, for treating BRCA2-mutated metastatic castration-sensitive prostate cancer. The regulatory nod, based on the pivotal AMPLITUDE trial, makes AKEEGA the first precision medicine combination approved for this high-risk

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Medical Devices & Diagnostics

How Baxter’s connected infusion pumps are transforming hospital bedside care

Baxter’s infusion pump data shows EMR integration boosts safety and reduces nurse workload. Find out how it could change hospital infusion practices.

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Pharma & Biotech

From ARPA-H to Basilea: What Phare Bio’s new deal reveals about biotech partnerships

Phare Bio and Basilea partner to develop an AI-designed antibiotic for deadly gram-negative infections. Explore what this deal could mean for the future of antimicrobial R&D.

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