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Pharma & Biotech

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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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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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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Pharma & Biotech

Acadia expands DAYBUE delivery formats for Rett syndrome with powder-based STIX

Acadia Pharmaceuticals has announced U.S. Food and Drug Administration approval for DAYBUE STIX (trofinetide) for oral solution, a new powder-based formulation of its existing drug DAYBUE used in the treatment of Rett syndrome. The approval covers use in adult and pediatric patients two years and older and is based on bioequivalence data, not new clinical

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Pharma & Biotech

Merck’s WINREVAIR clears major EU hurdle with CHMP backing for WHO FC IV patients

Merck has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an expanded indication for WINREVAIR (sotatercept) in combination with other therapies for the treatment of pulmonary arterial hypertension (PAH) in adults across WHO Functional Classes II, III, and IV. The update follows pivotal

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Pharma & Biotech

What Arcus Biosciences’ STAR-221 failure reveals about TIGIT fatigue in immunotherapy

Arcus Biosciences, Inc. has terminated its global Phase 3 STAR-221 study evaluating domvanalimab, an investigational anti-TIGIT antibody, in combination with zimberelimab and chemotherapy for advanced upper gastrointestinal cancers. The discontinuation, announced in partnership with Gilead Sciences, Inc., followed a pre-specified interim overall survival analysis that found no benefit compared to the nivolumab-based control arm. Arcus

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Pharma & Biotech

What makes LNK01006 a potentially best-in-class TYK2 inhibitor with central immune impact?

Lynk Pharmaceuticals and Formation Bio have entered an exclusive licensing and development agreement for LNK01006, a next-generation, central nervous system (CNS)-penetrant TYK2 inhibitor. The deal gives Formation Bio global rights to the asset outside Greater China, with plans to initiate a Phase 1 clinical trial in the United States during the first half of 2026.

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