Digital Health
Diagnostics

Trimedx adds agentic AI to TMX Protect to cut device cyber remediation

Trimedx says new natural-language AI capabilities in TMX Protect cut medical device cybersecurity remediation time by 75% on average.
Trimedx says new natural-language AI capabilities in TMX Protect cut medical device cybersecurity remediation time by 75% on average.
The Biotech Times Editorial Team  · 
Biologics

SOTIO's SOT106 ADC wins FDA Fast Track for soft tissue sarcoma

SOTIO Biotech's LRRC15-targeting antibody-drug conjugate gained Fast Track Designation, with a first-in-human study expected before year end.
SOTIO Biotech's LRRC15-targeting antibody-drug conjugate gained Fast Track Designation, with a first-in-human study expected before year end.
The Biotech Times Editorial Team  · 
Digital Health
Biotech

Big Digital Energy signs LOI for 17 MW AI campus in Texas

Big Digital Energy's joint venture has signed a non-binding letter of intent with Tensor IQ to develop a 17 MW AI and HPC
Big Digital Energy's joint venture has signed a non-binding letter of intent with Tensor IQ to develop a 17 MW AI and HPC
The Biotech Times Editorial Team  · 
Diagnostics

BridgeBio doses first patient in ASCEND-ATTR Phase 3b/4 study

BridgeBio has initiated ASCEND-ATTR, a 150-patient study testing whether long-term acoramidis can reverse cardiac damage in ATTR-CM.
BridgeBio has initiated ASCEND-ATTR, a 150-patient study testing whether long-term acoramidis can reverse cardiac damage in ATTR-CM.
The Biotech Times Editorial Team  · 
Biologics

Mesoblast posts US$120m revenue as RYONCIL ramps

Mesoblast reported sevenfold revenue growth in FY2026, driven by RYONCIL's US commercial launch, while its Phase 3 back pain trial completed patient treatment.
Mesoblast reported sevenfold revenue growth in FY2026, driven by RYONCIL's US commercial launch, while its Phase 3 back pain trial completed patient treatment.
The Biotech Times Editorial Team  · 
Digital Health
Biologics

Johns Hopkins wins NIH R01 to study GLP-1 long-term value

A five-year NIDDK-funded study will use Truveta's 140-million-patient dataset to assess GLP-1 cost-effectiveness and inform coverage decisions.
A five-year NIDDK-funded study will use Truveta's 140-million-patient dataset to assess GLP-1 cost-effectiveness and inform coverage decisions.
The Biotech Times Editorial Team  · 
Diagnostics

Femasys brings FemaSeed portfolio to UNC Health OB/GYN network

Femasys and UNC Health have partnered to offer in-office fertility diagnostics and intratubal insemination across the academic system's statewide OB/GYN locations.
Femasys and UNC Health have partnered to offer in-office fertility diagnostics and intratubal insemination across the academic system's statewide OB/GYN locations.
The Biotech Times Editorial Team  · 
Digital Health
Bioinformatics

Philips wins $33.7m ARPA-H award for AI robotic stroke care

Philips will work with Johns Hopkins and Boston University to develop remote and automated endovascular stroke procedures under the ARPA-H AIR programme.
Philips will work with Johns Hopkins and Boston University to develop remote and automated endovascular stroke procedures under the ARPA-H AIR programme.
The Biotech Times Editorial Team  · 
Regulatory Science
Biologics

Mereo BioPharma licenses alvelestat to Sentynl in $475m-plus US deal

Mereo will receive up to $475m and tiered royalties if Sentynl exercises its US commercialisation option for the oral AATD-LD candidate.
Mereo will receive up to $475m and tiered royalties if Sentynl exercises its US commercialisation option for the oral AATD-LD candidate.
The Biotech Times Editorial Team  · 
Biologics

MicrobiotiX clears sentinel cohort in first phage trial for pneumonia

MicrobiotiX's MP101 bacteriophage candidate passed its 72-hour safety review in South Korea's first MFDS-approved phage therapy trial.
MicrobiotiX's MP101 bacteriophage candidate passed its 72-hour safety review in South Korea's first MFDS-approved phage therapy trial.
The Biotech Times Editorial Team  · 
Regulatory Science
Biologics

INmune Bio files EMA packages for Ebstrocel in rare skin disease

INmune Bio has submitted an orphan drug designation application and pre-MAA scientific advice package to the EMA for its cell therapy Ebstrocel in RDEB.
INmune Bio has submitted an orphan drug designation application and pre-MAA scientific advice package to the EMA for its cell therapy Ebstrocel in RDEB.
The Biotech Times Editorial Team  · 
Biologics

Priovant's brepocitinib hits skin remission targets in Phase 3 DM trial

JAMA Dermatology publishes secondary endpoint data showing rapid, durable skin improvements for brepocitinib versus placebo in dermatomyositis.
JAMA Dermatology publishes secondary endpoint data showing rapid, durable skin improvements for brepocitinib versus placebo in dermatomyositis.
The Biotech Times Editorial Team  · 
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