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
Diagnostics

XYRA doses first European patient in budiodarone AF trial

XYRA LLC has dosed the first patient in Poland in HARBOR-AF, a Phase 2/3 study using wearable and implanted monitors to guide antiarrhythmic
XYRA LLC has dosed the first patient in Poland in HARBOR-AF, a Phase 2/3 study using wearable and implanted monitors to guide antiarrhythmic
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.
Biologics

Leios Therapeutics licenses 10XB-101 to CMS for China market

Leios Therapeutics has signed an exclusive licensing deal with CMS subsidiaries covering mainland China, its second major regional deal this year.
Leios Therapeutics has signed an exclusive licensing deal with CMS subsidiaries covering mainland China, its second major regional deal this year.
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.
Diagnostics
Biologics

Trinity Biotech faces Nasdaq delisting risk amid diagnostics overhaul

Dublin-based Trinity Biotech has requested a Nasdaq hearing after failing to meet the exchange's minimum market value threshold by its August deadline.
Dublin-based Trinity Biotech has requested a Nasdaq hearing after failing to meet the exchange's minimum market value threshold by its August deadline.
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

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.
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

Immuron posts record A$7.7m FY26 sales as CDI asset heads to partner

The Melbourne-based polyclonal antibody company reported 6% revenue growth and a A$1.4m profit improvement while advancing IMM-529 towards a Phase 2
The Melbourne-based polyclonal antibody company reported 6% revenue growth and a A$1.4m profit improvement while advancing IMM-529 towards a Phase 2
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
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.
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