Business, energy, technology, markets and global industry news from Business News Today
Pharma & Biotech

Lupin’s tentative FDA approval for enzalutamide sets up a high-value generic challenge to Xtandi

Lupin Limited has moved closer to the United States enzalutamide market with proposed 120 mg and 160 mg tablets that could reduce pill burden. Patent timing, final approval, market access and competition will determine whether that formulation advantage becomes commercially meaningful.

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Pharma & Biotech

Why LEO Pharma is shifting the chronic hand eczema debate from skin clearance to life impact

New analyses from the DELTA FORCE and DELTA TEEN programmes extend the chronic hand eczema discussion beyond skin clearance. The findings could strengthen the clinical and economic case for delgocitinib, although real-world effectiveness, adolescent regulation and treatment access remain important tests.

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Pharma & Biotech

Glaukos completes enrollment in GLK-321 trial as Demodex therapy competition grows

Discover how Glaukos’ GLK-321 Phase 2 trial could reshape Demodex blepharitis care through a dropless eyelid-applied treatment.

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Medical Devices & Diagnostics

Why Natera’s Prospera could reshape how Eledon measures kidney transplant injury in Phase 3

Natera’s Prospera assay will provide serial molecular graft surveillance in Eledon’s planned Phase 3 tegoprubart study, creating a major test of how diagnostics can strengthen transplant drug development.

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Pharma & Biotech

Merck and Gilead secure FDA approval for a new ADC-immunotherapy backbone in advanced TNBC

The new regimen replaces conventional chemotherapy with a Trop-2-directed antibody-drug conjugate while retaining PD-1 blockade, offering longer disease control but leaving overall survival, sequencing and cost questions unresolved.

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Medical Devices & Diagnostics

How Johnson & Johnson’s dual-energy THERMOCOOL platform could reshape European atrial fibrillation ablation

The Dual Energy THERMOCOOL SMARTTOUCH SF Platform gives electrophysiologists pulsed field and radiofrequency ablation through one catheter, expanding procedural flexibility while raising new questions about evidence, efficiency and adoption.

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Pharma & Biotech

Gilead expands Trodelvy into first-line metastatic TNBC, but survival questions remain unresolved

The decision gives clinicians a Trodelvy-based option for patients who cannot receive checkpoint inhibitors and a Trodelvy plus Keytruda regimen for PD-L1-positive disease. The immediate clinical impact is substantial, although immature overall-survival data, toxicity management and treatment cost will influence how rapidly the new pathways displace chemotherapy.

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Pharma & Biotech

Ionis Pharmaceuticals moves beyond rare disease as Tryngolza enters the wider triglyceride market

Tryngolza is no longer confined to the rare familial chylomicronemia syndrome market. Its broader United States approval gives clinicians the first therapy specifically shown to reduce acute pancreatitis risk in adults with severe hypertriglyceridemia, although questions surrounding dose selection, hepatic monitoring, reimbursement and long-term use will influence how quickly the treatment changes practice.

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Pharma & Biotech

Pfizer’s Ibrance wins broader FDA role as metastatic breast cancer treatment becomes more complex

The FDA approval brings CDK4/6 inhibition into HR-positive, HER2-positive metastatic breast cancer maintenance, although toxicity, immature survival data and a rapidly changing first-line market could shape adoption.

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Pharma & Biotech

Why Kadima is suing NRx Pharmaceuticals over the failed HOPE Therapeutics acquisition

The legal fight over Kadima Neuropsychiatry Institute tests NRx Pharmaceuticals’ acquisition discipline, financing credibility and evolving interventional psychiatry strategy.

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