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Pharma & Biotech

Pharma & Biotech

Alterity gains a streamlined FDA pathway as ATH434 faces its decisive clinical test

Alterity Therapeutics has secured an FDA-aligned Phase 3 pathway for ATH434 in multiple system atrophy, with one pivotal study potentially supporting an approval application.

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Pharma & Biotech

Novartis expands oncology pipeline with $1.5bn Myricx Bio acquisition

Novartis is acquiring Myricx Bio for up to $1.5 billion to gain control of a new NMT inhibitor payload platform, but the lead antibody-drug conjugates have not yet entered human trials.

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Pharma & Biotech

ITM nears FDA decision after positive COMPETE radiopharmaceutical trial

ITM’s lutetium-177 edotreotide extended median progression-free survival to 23.9 months versus 14.1 months with everolimus, strengthening its regulatory and commercial case in advanced neuroendocrine tumours.

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Pharma & Biotech

Otsuka’s Astex secures $515m Roche deal for cell-cycle breast cancer candidates

Discover why Roche and Otsuka-owned Astex are pursuing a $515 million cell-cycle breast cancer programme and what risks remain.

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Pharma & Biotech

Ionis fills pivotal Angelman syndrome cohort, but can obudanersen confirm its early promise?

Discover why Ionis' REVEAL enrollment turns obudanersen into a decisive Phase 3 test for Angelman syndrome treatment.

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Pharma & Biotech

Agenus BOTBAL survival data challenges expectations in MSS metastatic colorectal cancer

Explore how Agenus BOTBAL achieved 33% three-year survival in refractory MSS colorectal cancer and what Phase 3 must prove next.

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Pharma & Biotech

Alzheon builds oral Alzheimer’s case around brain microstructure and lower ARIA risk

Explore how Alzheon’s new valiltramiprosate brain and safety data could reshape oral Alzheimer’s treatment after a Phase 3 setback.

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Pharma & Biotech

Why Natera’s latest Signatera study matters for resected metastatic colorectal cancer

Discover how Natera’s Signatera MRD test may sharpen chemotherapy decisions after colorectal liver surgery and what remains unproven.

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Pharma & Biotech

Why Aurinia’s new Lupkynis trial could change the lupus nephritis treatment sequence

Discover how Aurinia’s PRESERVE study could reshape lupus nephritis care by combining Lupkynis with three major biologic therapies.

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Pharma & Biotech

Can Lineage turn early retinal repair signals into a credible late-stage OpRegen pathway?

Discover why Lineage Cell Therapeutics’ OpRegen and OPC1 programmes now face critical delivery, trial design and manufacturing tests.

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