North America

The United States and Canada.
Pharmaceuticals
Regulatory Science

Quoin Pharma wins FDA Fast Track for QRX003 in Peeling Skin Syndrome

Quoin Pharmaceuticals secured the first-ever Fast Track Designation for a Peeling Skin Syndrome therapy, with a Phase 2/3 trial set to start by
Quoin Pharmaceuticals secured the first-ever Fast Track Designation for a Peeling Skin Syndrome therapy, with a Phase 2/3 trial set to start by
The Biotech Times Editorial Team  · 
Medical Devices

Traferox X°Port Heart wins FDA 510(k) clearance for transplant use

Traferox Technologies has secured FDA 510(k) clearance for its X°Port Heart Preservation System, targeting improved donor heart outcomes via 10°C static cold
Traferox Technologies has secured FDA 510(k) clearance for its X°Port Heart Preservation System, targeting improved donor heart outcomes via 10°C static cold
The Biotech Times Editorial Team  · 
Biotech

Patient safety checklist marks 25 years with reform agenda unfinished

Dr Peter Pronovost's ICU infection checklist turns 25, but patient harm rates in US hospitals have barely shifted in a generation.
Dr Peter Pronovost's ICU infection checklist turns 25, but patient harm rates in US hospitals have barely shifted in a generation.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

AnaptysBio reports Jemperli royalties up 34% as FDA decision looms

AnaptysBio posted $644m in Jemperli global net sales for H1 2026 and expects an FDA ruling on a rectal cancer indication by February 2027.
AnaptysBio posted $644m in Jemperli global net sales for H1 2026 and expects an FDA ruling on a rectal cancer indication by February 2027.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics

Avalyn publishes Phase 1 data showing AP02's lung-targeted delivery

Peer-reviewed Phase 1 results confirm nebulised nintedanib achieved 26-fold higher lung exposure than the oral dose, with no serious adverse events.
Peer-reviewed Phase 1 results confirm nebulised nintedanib achieved 26-fold higher lung exposure than the oral dose, with no serious adverse events.
The Biotech Times Editorial Team  · 
Digital Health

New Era Energy inks 20-year, 207 MW power deal with Vistra

New Era Energy & Digital has contracted firm power for Phase 1 of its Texas data centre, with Vistra supplying up to 207 MW from an
New Era Energy & Digital has contracted firm power for Phase 1 of its Texas data centre, with Vistra supplying up to 207 MW from an
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Pharmaceuticals

Vironexis VNX-101 achieves MRD-negative responses in R/R ALL

All three antibody-naïve relapsed/refractory ALL patients in SENTRY-CD19 achieved durable MRD-negative complete responses after a single VNX-101 infusion.
All three antibody-naïve relapsed/refractory ALL patients in SENTRY-CD19 achieved durable MRD-negative complete responses after a single VNX-101 infusion.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Bioprocessing
Biologics

Avaí Bio clears cell bank safety testing for Klotho therapy

Avaí Bio and Austrianova confirmed their Master Cell Bank is free of more than 30 viruses, unlocking the next development stage for an α-Klotho
Avaí Bio and Austrianova confirmed their Master Cell Bank is free of more than 30 viruses, unlocking the next development stage for an α-Klotho
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

CDT Equity and QIMA to test tapinarof combos in psoriasis

CDT Equity is partnering with dermatology CRO QIMA Life Sciences to evaluate novel tapinarof combinations in psoriasis and vitiligo using human patient skin tissue.
CDT Equity is partnering with dermatology CRO QIMA Life Sciences to evaluate novel tapinarof combinations in psoriasis and vitiligo using human patient skin tissue.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Pharmaceuticals

Longeveron HLHS stem cell trial misses primary endpoint

ELPIS II did not meet its RVEF primary endpoint at 12 months, but exploratory data showed fewer cardiovascular events in treated infants.
ELPIS II did not meet its RVEF primary endpoint at 12 months, but exploratory data showed fewer cardiovascular events in treated infants.
The Biotech Times Editorial Team  · 
Medical Devices

Milestone Scientific adds Pain and Spine to CompuFlo Programme

Milestone Scientific named Pain and Spine Specialists and Dr Sudhir Rao as development partners to advance its CompuFlo epidural confirmation technology.
Milestone Scientific named Pain and Spine Specialists and Dr Sudhir Rao as development partners to advance its CompuFlo epidural confirmation technology.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Teva study shows HCPs favour AUSTEDO attributes for older TD patients

A discrete choice experiment involving 489 clinicians found somnolence risk and symptom improvement are the top priorities when selecting a VMAT2 inhibitor for tardive
A discrete choice experiment involving 489 clinicians found somnolence risk and symptom improvement are the top priorities when selecting a VMAT2 inhibitor for tardive
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics
Bioinformatics

Roche opens Boston CVRM hub at Harvard campus as part of $50bn US push

Roche and Genentech have opened a 95,000 sq m Innovation Center in Allston, Boston, housing up to 500 staff focused on cardiovascular, renal and
Roche and Genentech have opened a 95,000 sq m Innovation Center in Allston, Boston, housing up to 500 staff focused on cardiovascular, renal and
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health
Medical Devices

Spectral AI showcases DeepView burn diagnostic at SRBC

Spectral AI displayed its FDA-cleared DeepView multispectral imaging system at the Southern Regional Burn Conference, with two KOL presentations backing its clinical
Spectral AI displayed its FDA-cleared DeepView multispectral imaging system at the Southern Regional Burn Conference, with two KOL presentations backing its clinical
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Telomir Pharmaceuticals publishes preclinical AMD data for Telomir-Zn

A peer-reviewed zebrafish study shows Telomir-Zn restored visual function and retinal structure, extending the drug's biology beyond its lead oncology programme.
A peer-reviewed zebrafish study shows Telomir-Zn restored visual function and retinal structure, extending the drug's biology beyond its lead oncology programme.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Teva's UZEDY shows lower ER visits and cost savings in real-world data

New observational data presented at Psych Congress show UZEDY outperformed rival long-acting injectables on treatment continuity and cut monthly healthcare costs by over
New observational data presented at Psych Congress show UZEDY outperformed rival long-acting injectables on treatment continuity and cut monthly healthcare costs by over
The Biotech Times Editorial Team  · 
Medical Devices

AVAVA raises $45m to scale Focal Point Technology aesthetics platform

AVAVA secured a $45m mixed equity and debt round led by returning backer Catalio Capital to fund commercial expansion and its next-generation device pipeline.
AVAVA secured a $45m mixed equity and debt round led by returning backer Catalio Capital to fund commercial expansion and its next-generation device pipeline.
The Biotech Times Editorial Team  · 
Medical Devices
Biotech

BioStem Technologies secures $40m committed equity facility with Roth

The Nasdaq-listed perinatal tissue allograft maker has agreed a $40 million at-will equity facility with Roth Principal Investments for working capital purposes.
The Nasdaq-listed perinatal tissue allograft maker has agreed a $40 million at-will equity facility with Roth Principal Investments for working capital purposes.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Cardiff Oncology and NMS settle dispute and expand onvansertib deal

Cardiff Oncology and Nerviano Medical Sciences have resolved litigation and expanded their 2017 licence agreement, clearing the path for a global Phase 3 trial of
Cardiff Oncology and Nerviano Medical Sciences have resolved litigation and expanded their 2017 licence agreement, clearing the path for a global Phase 3 trial of
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics

CooperCompanies posts $1.07bn Q3 revenue amid CVI inventory drag

CooperCompanies hit $1.07bn in Q3 revenue but warned a US channel inventory reduction at CooperVision will weigh into the fourth quarter.
CooperCompanies hit $1.07bn in Q3 revenue but warned a US channel inventory reduction at CooperVision will weigh into the fourth quarter.
The Biotech Times Editorial Team  · 
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