Innovation

Biologics
Regulatory Science

Novartis wins EC approval for Itvisma in broader SMA population

The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
Biologics
Regulatory Science

PolarityBio files BLA for SkinTE in diabetic foot ulcers

PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
Proteomics
Diagnostics

Seer wins EPO patent ruling and secures ITC probe into Nanomics

Seer has defended a key European proteomics patent and launched a US trade investigation targeting Nanomics' competing Proteonano products.
Seer has defended a key European proteomics patent and launched a US trade investigation targeting Nanomics' competing Proteonano products.
Digital Health

Startup Coalition and DSIT launch Pitch in Whitehall competition

UK startups have until 24 July to apply for a government proof-of-concept contract under the Green Compute challenge.
UK startups have until 24 July to apply for a government proof-of-concept contract under the Green Compute challenge.
Biologics

4DMT completes 4FRONT-2 Phase 3 enrolment four months ahead of schedule

4D Molecular Therapeutics has finished global enrolment for its wet AMD gene therapy trial, with topline 52-week data expected in the second half of
4D Molecular Therapeutics has finished global enrolment for its wet AMD gene therapy trial, with topline 52-week data expected in the second half of
Biologics
Regulatory Science

AdJane reports first human proof-of-concept for intranasal OMV vaccine

The Dutch biotech's Phase I data show its nOMV platform induced mucosal and systemic immunity in healthy adults, published in peer-reviewed journal Vaccines.
The Dutch biotech's Phase I data show its nOMV platform induced mucosal and systemic immunity in healthy adults, published in peer-reviewed journal Vaccines.
Regulatory Science

Serenity Medical wins FDA Breakthrough Device tag for tinnitus stent

The Shepherd Stent System targets venous sinus stenosis in severe pulsatile tinnitus, a condition linked to depression and elevated suicide risk.
The Shepherd Stent System targets venous sinus stenosis in severe pulsatile tinnitus, a condition linked to depression and elevated suicide risk.
Digital Health
Diagnostics

Firstsource and AppliedAI report 95% cuts in live AI deployments

Six months after a strategic equity deal, the partners say live deployments cut healthcare processing times by 93% and lifted admissions throughput up to tenfold.
Six months after a strategic equity deal, the partners say live deployments cut healthcare processing times by 93% and lifted admissions throughput up to tenfold.
Digital Health

Isle of Man names four winners of 2026 health innovation challenge

Four digital health companies were selected from 125 global entries to win the Isle of Man's annual Innovation Challenge on Health and Social Care.
Four digital health companies were selected from 125 global entries to win the Isle of Man's annual Innovation Challenge on Health and Social Care.
Cell & Gene Therapy

IBA to install Brazil's first proton therapy centre in Rio de Janeiro

IBA has signed a contract with FUSVE to bring proton therapy to Brazil for the first time, with a focus on paediatric cancer care.
IBA has signed a contract with FUSVE to bring proton therapy to Brazil for the first time, with a focus on paediatric cancer care.
Biologics
Regulatory Science

INmune Bio wins MHRA PIP approval for Ebstrocel in RDEB

The MHRA cleared INmune Bio's paediatric investigation plan in under three months, keeping the company's 2026 UK marketing authorisation application on track.
The MHRA cleared INmune Bio's paediatric investigation plan in under three months, keeping the company's 2026 UK marketing authorisation application on track.
Bioprocessing

TISSIUM raises €60m to back COAPTIUM launch and pipeline growth

The Paris-based MedTech has combined a €30m Series D2 with a €30m EIB facility to fund US commercialisation of its FDA-cleared polymer repair
The Paris-based MedTech has combined a €30m Series D2 with a €30m EIB facility to fund US commercialisation of its FDA-cleared polymer repair
Biologics

Sanofi wins EU approval for tolebrutinib in progressive MS

The European Commission has approved Cenrifki for non-relapsing secondary progressive MS, making it the first therapy to target disability progression in the indication.
The European Commission has approved Cenrifki for non-relapsing secondary progressive MS, making it the first therapy to target disability progression in the indication.
Genomics
Diagnostics
Bioinformatics

Bionano OGM studies at ESHG 2026 surge 67% year-on-year

Thirty-five studies featuring optical genome mapping appeared at ESHG 2026, up from 21 the prior year, spanning authors across 17 countries.
Thirty-five studies featuring optical genome mapping appeared at ESHG 2026, up from 21 the prior year, spanning authors across 17 countries.
Biologics
Regulatory Science

ENA Respiratory secures two US patents for TLR2 agonist COPD programme

USPTO notices of allowance extend INNA-051's potential US exclusivity to at least 2042, covering both composition of matter and rhinovirus-mediated COPD exacerbations.
USPTO notices of allowance extend INNA-051's potential US exclusivity to at least 2042, covering both composition of matter and rhinovirus-mediated COPD exacerbations.
Diagnostics

IBA reshuffles leadership as de Romrée takes operational control

IBA has elevated Henri de Romrée to full operational leadership while founder-era CEO Olivier Legrain shifts to board vice-chairman and strategic oversight.
IBA has elevated Henri de Romrée to full operational leadership while founder-era CEO Olivier Legrain shifts to board vice-chairman and strategic oversight.
Regulatory Science

Nephros touts ultrafiltration tech as microplastic risk gains EPA focus

Nephros says its 5-nanometre pore filters capture both microplastics and nanoplastics, following the EPA's April 2026 decision to prioritise plastic particle
Nephros says its 5-nanometre pore filters capture both microplastics and nanoplastics, following the EPA's April 2026 decision to prioritise plastic particle
Digital Health

CosmoFarm posts record $15m Q2 revenue on pharmacy network growth

The Athens-based pharmaceutical wholesaler added over 80 pharmacies in Q2 2026, lifting Cosmos Health's annualised revenue run-rate beyond $60 million.
The Athens-based pharmaceutical wholesaler added over 80 pharmacies in Q2 2026, lifting Cosmos Health's annualised revenue run-rate beyond $60 million.
Biologics

MAIA Biotechnology opens third US site for ateganosine Phase 2 trial

Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
Synthetic Biology

Amber Implants expands EXPAND study of VCFix to eight European centres

The Dutch medtech has enrolled 15 patients and expanded its pivotal vertebral reconstruction trial across Germany and France.
The Dutch medtech has enrolled 15 patients and expanded its pivotal vertebral reconstruction trial across Germany and France.
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