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Features & Analysis

Why GalNAc made the liver the easiest organ for RNA medicines and exposed how hard the rest of the body remains

GalNAc exploits millions of rapidly recycling receptors on hepatocytes to deliver siRNA with remarkable efficiency, enabling durable gene silencing after subcutaneous dosing while highlighting the unresolved challenge of extrahepatic RNA delivery.

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Medical Devices & Diagnostics

Pillar Biosciences takes cfDNA and cfRNA screening into 2,000-patient LC-SCRUM-Asia lung cancer project

LSI Medience has validated Pillar’s oncoReveal Essential+ for cfDNA and cfRNA screening, with approximately 2,000 lung cancer patients expected to enter testing over two years.

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Medical Devices & Diagnostics

Nipro launches ELISIO-HX in the US as expanded hemodialysis targets harder-to-remove toxins

Nipro’s newly FDA-cleared ELISIO-HX is designed to remove larger uremic middle molecules while retaining essential proteins and working with existing hemodialysis infrastructure.

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Pharma & Biotech

Japan clears IMCIVREE for acquired hypothalamic obesity as Rhythm Pharmaceuticals expands global reach

Japan approves IMCIVREE for acquired hypothalamic obesity, expanding Rhythm Pharmaceuticals’ global franchise. See what the approval means for growth.

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Pharma & Biotech

ERAS-0015 gets FDA Fast Track status after 57% response signal in pancreatic cancer

ERAS-0015 wins FDA Fast Track status after a 57% early response signal in KRAS pancreatic cancer as Erasca prepares three registration-focused trials.

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Pharma & Biotech

Deramiocel gets three more months at FDA as Capricor shifts Duchenne approval case to arm function

FDA extends deramiocel review to November 22 as Capricor submits new HOPE-3 data supporting an upper limb function indication in Duchenne.

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Pharma & Biotech

ACTG repurposes osteoporosis drug alendronate in 30-person trial targeting the hidden HIV reservoir

STAIR-HIV will randomize 30 virally suppressed adults to weekly alendronate or placebo, testing whether a familiar osteoporosis medicine can perturb persistent HIV reservoirs despite continued ART.

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Pharma & Biotech

Ipsen closes up to $1.75bn Kartos deal as navtemadlin enters its decisive Phase 3 myelofibrosis test

Ipsen has completed its Kartos Therapeutics acquisition, paying $450 million upfront with up to $1.3 billion in milestones while the 600-patient POIESIS trial tests navtemadlin plus ruxolitinib.

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Features & Analysis

Can organoids and organs-on-chips really replace animal testing in drug development?

FDA is actively encouraging organoids, organs-on-chips and computational models as alternatives to some animal studies, but reproducibility, validation and whole-body biology still prevent a simple one-for-one replacement.

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Medical Devices & Diagnostics

Wellspect takes Surity urine management into the US home as external collection moves beyond hospital use

Wellspect has launched a suction-based urine collection system for home use in the United States, completing a Surity portfolio built around female and male external catheters rather than indwelling drainage.

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