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Pharma & Biotech

EMA backs ANKTIVA for bladder cancer: What it means for EU patients and future immunotherapies

ImmunityBio Inc. has received a positive recommendation from the European Medicines Agency for conditional marketing authorization of its immunotherapy ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin for the treatment of BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ. The recommendation positions ANKTIVA as the first immunotherapy in the European Union for this indication,

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Veritiv bets on recyclability with TempSafe PalletShield for cold chain pallet logistics
Pharma & Biotech

From waste to curbside: Veritiv’s fiber-based PalletShield reshapes pallet shipper expectations

Veritiv Operating Company has launched TempSafe PalletShield, a pre-qualified, fiber-based pallet shipper for cold chain logistics, designed to offer curbside recyclability without compromising thermal performance. The system delivers more than five days of validated temperature control and is capable of holding up to 596 liters and 300 pounds of dry ice, specifically targeting the needs

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Pharma & Biotech

Gonorrhea resistance crisis: Can Innoviva’s zoliflodacin rewrite treatment guidelines?

Innoviva Specialty Therapeutics has reported publication of pivotal Phase 3 data in The Lancet showing that its investigational oral antibiotic zoliflodacin was non-inferior to the current standard-of-care dual therapy for uncomplicated urogenital gonorrhea. The study, conducted in partnership with the Global Antibiotic Research & Development Partnership, or GARDP, compared a single oral dose of zoliflodacin

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Medical Devices & Diagnostics

Ruthless Spine’s RJB device approved in Israel, expanding navigation tech reach

Gad Medical Ltd. has received regulatory clearance in Israel to commence commercial distribution of the RJB intraoperative angle measurement system from Ruthless Spine, a United States-based medical technology company. This milestone follows the companies’ earlier distribution agreement and paves the way for hospitals and surgical centers across Israel to integrate the RJB platform into thoracolumbar

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Pharma & Biotech

How Indivumed’s biospecimen strategy is powering functional tumor model development

Indivumed GmbH and the Wilmot Cancer Institute at the University of Rochester Medical Center have expanded their collaboration to accelerate the development of patient-derived tumor models and AI-informed therapeutic discovery for solid tumors with high unmet clinical need. What this collaboration changes for the cancer model ecosystem The expansion of the Indivumed and University of

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Pharma & Biotech

Is Kazia’s paxalisib becoming the new backbone for checkpoint combos?

Kazia Therapeutics Limited has presented new clinical and translational data at the 2025 San Antonio Breast Cancer Symposium demonstrating that paxalisib, its investigational brain-penetrant PI3K/mTOR inhibitor, may suppress circulating tumor cell clusters and reverse immune exhaustion in two of the most treatment-resistant breast cancer subtypes—HER2-positive metastatic breast cancer and triple-negative breast cancer. The early evidence,

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Pharma & Biotech

Can Diakonos Oncology’s DOC1021 reawaken immune response in refractory melanoma?

Diakonos Oncology Corporation has received over $7 million from the Cancer Prevention and Research Institute of Texas to initiate a Phase 1/2 clinical trial of its double-loaded dendritic cell therapy, DOC1021, in patients with refractory melanoma. The grant places the investigational therapy into its third solid tumor indication and signals rising institutional interest in immune-based

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Features & Analysis

Is AI finally ready to close the equity gap in breast cancer screening in the United States and beyond?

The rapid progress of artificial intelligence in medical imaging is creating fresh optimism among healthcare leaders seeking to close the persistent equity gap in breast cancer screening. The regulatory push by Lunit, a Seoul-based AI diagnostics firm, for its Lunit INSIGHT Risk model, which estimates a woman’s five-year breast cancer risk directly from mammogram images,

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Features & Analysis

Can next-gen immunotherapy combos finally crack the code in metastatic breast cancer?

The landscape of metastatic breast cancer treatment is facing a fundamental rethink, with the oncology field laser-focused on one of its greatest clinical challenges: how to break immune resistance and stop metastatic spread. Despite a wave of checkpoint inhibitor approvals and initial enthusiasm, progress in metastatic breast cancer—especially for subtypes like triple-negative and HER2-positive disease—has

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Pharma & Biotech

Why the MiRaDoR study may redefine therapeutic timing in HR+/HER2- patients

Natera Inc. and Medica Scientia Innovation Research (MEDSIR) have announced a collaborative effort on the MiRaDoR study, a multicenter, phase II clinical trial focused on hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer. Sponsored by MEDSIR and funded by F. Hoffmann-La Roche Ltd., the trial uses Natera’s Signatera assay to guide therapy decisions based on circulating tumor

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