Biologics
Regulatory Science

Ascendis and BioMarin settle YUVIWEL dispute with royalty deal

Ascendis Pharma will pay BioMarin royalties of up to 20% on navepegritide net sales through May 2030 to resolve all litigation between the two companies.
Ascendis Pharma will pay BioMarin royalties of up to 20% on navepegritide net sales through May 2030 to resolve all litigation between the two companies.
Biologics

Arch Biopartners wins IRB approval to open U.S. sites in CS-AKI trial

The Canadian biotech cleared a central IRB review for its Phase II LSALT peptide study, bringing five U.S. institutions closer to activation.
The Canadian biotech cleared a central IRB review for its Phase II LSALT peptide study, bringing five U.S. institutions closer to activation.
Biologics
Regulatory Science

Alvotech wins FDA review acceptance for AVT80 vedolizumab biosimilar

Alvotech's BLA for AVT80, a proposed interchangeable subcutaneous biosimilar to Entyvio, has been accepted for review by the FDA, completing its dual-presentation
Alvotech's BLA for AVT80, a proposed interchangeable subcutaneous biosimilar to Entyvio, has been accepted for review by the FDA, completing its dual-presentation
Digital Health
Medical Devices

LEAP 2026 opens with health tech on the fringe of an AI show

The HealthTech track and two headline device demonstrations are what life sciences gets this year, with no biotech deal announced as the fifth edition opened.
The HealthTech track and two headline device demonstrations are what life sciences gets this year, with no biotech deal announced as the fifth edition opened.
Digital Health

Globus Medical acquires Duke-incubated AI firm Higgs Boson Health

The NYSE-listed musculoskeletal device maker is buying Durham-based Higgs Boson Health to build out a surgical intelligence and patient-journey platform.
The NYSE-listed musculoskeletal device maker is buying Durham-based Higgs Boson Health to build out a surgical intelligence and patient-journey platform.
Biologics
Diagnostics

Acoramidis shows structural cardiac reversal in 54-month ATTR-CM data

BridgeBio's Attruby generated CMR evidence of cardiac structural reversal and 65 extra days alive out of hospital at three years in ATTR-CM patients.
BridgeBio's Attruby generated CMR evidence of cardiac structural reversal and 65 extra days alive out of hospital at three years in ATTR-CM patients.
Regulatory Science

Artelo Biosciences wins US patent allowance for ART27.13 formulation

The Nasdaq-listed biotech secured IP protection for its cannabinoid agonist's commercial formulation, extending coverage to 2041 across two active Phase 2 studies.
The Nasdaq-listed biotech secured IP protection for its cannabinoid agonist's commercial formulation, extending coverage to 2041 across two active Phase 2 studies.
Diagnostics

Autonomix Medical secures US patent on feedback-guided neuromodulation

Autonomix Medical has been granted a US patent covering real-time feedback-guided precision neuromodulation systems, including neural ablation for cancer pain relief.
Autonomix Medical has been granted a US patent covering real-time feedback-guided precision neuromodulation systems, including neural ablation for cancer pain relief.
Biologics

Coloplast reshuffles ELT with new CPO and Wound unit interim lead

Coloplast appoints Amanda Rajkumar as Chief People Officer and moves Kerecis founder Fertram Sigurjonsson into an innovation advisory role.
Coloplast appoints Amanda Rajkumar as Chief People Officer and moves Kerecis founder Fertram Sigurjonsson into an innovation advisory role.
Biologics

Coloplast posts 6% organic growth in Q3 amid Biologics drag

The Danish medtech reported solid third-quarter trading across Chronic Care but flagged a 6% sales decline in Biologics due to reimbursement changes.
The Danish medtech reported solid third-quarter trading across Chronic Care but flagged a 6% sales decline in Biologics due to reimbursement changes.
Biologics

HUTCHMED SANOVO trial shows PFS gain for savolitinib plus osimertinib

HUTCHMED's Phase III SANOVO trial met its primary endpoint in treatment-naïve MET-overexpressing EGFR-mutated NSCLC, with an encouraging early overall survival signal.
HUTCHMED's Phase III SANOVO trial met its primary endpoint in treatment-naïve MET-overexpressing EGFR-mutated NSCLC, with an encouraging early overall survival signal.
Digital Health
Bioinformatics

Fangzhou posts 22% revenue rise on AI chronic care push

The Hong Kong-listed platform reported RMB 1.82bn in H1 2026 revenue, driven by its proprietary XingShi LLM and a fast-growing chronic disease
The Hong Kong-listed platform reported RMB 1.82bn in H1 2026 revenue, driven by its proprietary XingShi LLM and a fast-growing chronic disease
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