Regulation

Regulatory Science

Claria Medical wins FDA De Novo clearance for hysterectomy device

The Claria System is the first integrated tissue containment and removal device cleared by the FDA, cutting median uterine extraction time to four minutes.
The Claria System is the first integrated tissue containment and removal device cleared by the FDA, cutting median uterine extraction time to four minutes.
The Biotech Times Editorial Team  · 
Biologics

Mesoblast hits 300-patient target in Phase 3 back pain trial

Mesoblast said its pivotal rexlemestrocel-L trial is now fully enrolled, with top-line results expected in mid-2027 and a BLA filing to follow.
Mesoblast said its pivotal rexlemestrocel-L trial is now fully enrolled, with top-line results expected in mid-2027 and a BLA filing to follow.
The Biotech Times Editorial Team  · 
Biologics

Xeltis makes first commercial implant of aXess vascular access device

The Eindhoven medtech has begun its European commercial rollout of aXess, a bioabsorbable hemodialysis graft designed to regenerate into the patient's own living vessel.
The Eindhoven medtech has begun its European commercial rollout of aXess, a bioabsorbable hemodialysis graft designed to regenerate into the patient's own living vessel.
The Biotech Times Editorial Team  · 
Diagnostics

Endogenex completes 350-patient enrolment in ReCET diabetes device trial

Endogenex has fully enrolled its sham-controlled ReCET study of a duodenal pulsed electric field device for type 2 diabetes across 40 sites.
Endogenex has fully enrolled its sham-controlled ReCET study of a duodenal pulsed electric field device for type 2 diabetes across 40 sites.
The Biotech Times Editorial Team  · 
Diagnostics

Tarsus Pharmaceuticals acquires iRenix Medical for up to $565m

Tarsus is acquiring iRenix and its IRX-101 ocular antiseptic, backed by Phase 2b/3 data showing significant pain and corneal toxicity reductions.
Tarsus is acquiring iRenix and its IRX-101 ocular antiseptic, backed by Phase 2b/3 data showing significant pain and corneal toxicity reductions.
The Biotech Times Editorial Team  · 
Diagnostics
Biologics

Roche wins CE Mark for automated blood test for latent TB

The Elecsys IGRA TB test processes samples in 19 minutes, cutting standard IGRA turnaround in half and integrating with Roche's existing cobas immunoassay platforms.
The Elecsys IGRA TB test processes samples in 19 minutes, cutting standard IGRA turnaround in half and integrating with Roche's existing cobas immunoassay platforms.
The Biotech Times Editorial Team  · 
Biologics

Ipsen Dysport hits Phase III endpoints in episodic and chronic migraine

Ipsen's abobotulinumtoxinA met primary endpoints in both BEOND trials, becoming the first botulinum toxin with Phase III efficacy across episodic and chronic migraine.
Ipsen's abobotulinumtoxinA met primary endpoints in both BEOND trials, becoming the first botulinum toxin with Phase III efficacy across episodic and chronic migraine.
The Biotech Times Editorial Team  · 
Diagnostics
Biotech

Urteste wins USPTO patent for urine-based Panuri pancreatic cancer test

The Polish diagnostics company secured US patent protection for its non-invasive Panuri test as a European clinical trial enrols its first participants.
The Polish diagnostics company secured US patent protection for its non-invasive Panuri test as a European clinical trial enrols its first participants.
The Biotech Times Editorial Team  · 
Biologics
Bioprocessing

Pluristyx secures Japan patent for synthetic mRNA iPSC reprogramming

The Seattle biotech's licensed mRNA technology cuts iPSC line generation to under 30 days, addressing a key bottleneck for commercial cell therapy manufacturing.
The Seattle biotech's licensed mRNA technology cuts iPSC line generation to under 30 days, addressing a key bottleneck for commercial cell therapy manufacturing.
The Biotech Times Editorial Team  · 
Biotech

PetMed Express confirms revised $3 takeover bid from SilverCape

SilverCape Investments has lowered its unsolicited offer to $3.00 per share, down from $4.00 in December, as PetMeds' board evaluates its options.
SilverCape Investments has lowered its unsolicited offer to $3.00 per share, down from $4.00 in December, as PetMeds' board evaluates its options.
The Biotech Times Editorial Team  · 
Regulatory Science

Incannex secures US patent for IHL-42X sleep apnoea therapy to 2040

Incannex Healthcare has won a USPTO patent covering its oral OSA combination therapy IHL-42X, with baseline protection running to July 2040.
Incannex Healthcare has won a USPTO patent covering its oral OSA combination therapy IHL-42X, with baseline protection running to July 2040.
The Biotech Times Editorial Team  · 
Biologics

FibroBiologics wins patent allowance for 3D spheroid wound therapy

The Houston biotech secured USPTO allowance for fibroblast spheroid wound healing claims that directly cover its Phase 1/2 CYWC628 diabetic foot ulcer programme.
The Houston biotech secured USPTO allowance for fibroblast spheroid wound healing claims that directly cover its Phase 1/2 CYWC628 diabetic foot ulcer programme.
The Biotech Times Editorial Team  · 
Regulatory Science

CervoMed secures US patent on neflamapimod for pure DLB to 2042

CervoMed has received a USPTO notice of allowance for a patent covering neflamapimod in pure dementia with Lewy bodies, extending protection into 2042.
CervoMed has received a USPTO notice of allowance for a patent covering neflamapimod in pure dementia with Lewy bodies, extending protection into 2042.
The Biotech Times Editorial Team  · 
Regulatory Science

Cingulate secures first US patent on CTx-1301 ADHD tablet

The Kansas City biopharmaceutical company said US Patent No. 12,653,791 protects its trimodal dexmethylphenidate formulation through December 2042.
The Kansas City biopharmaceutical company said US Patent No. 12,653,791 protects its trimodal dexmethylphenidate formulation through December 2042.
The Biotech Times Editorial Team  · 

FocalTherics launches endometriosis HIFU programme in Europe

FocalTherics has treated initial patients at Toulouse University Hospital using its Focal One Robotic HIFU system for deep infiltrating endometriosis.
FocalTherics has treated initial patients at Toulouse University Hospital using its Focal One Robotic HIFU system for deep infiltrating endometriosis.
The Biotech Times Editorial Team  · 
Diagnostics

Vilnius University physicists patent pea-sized triplex radiation sensor

A three-layer sensor developed at Vilnius University can detect, identify and locate radiation sources in real time, from lab doses to megagray nuclear emergency
A three-layer sensor developed at Vilnius University can detect, identify and locate radiation sources in real time, from lab doses to megagray nuclear emergency
The Biotech Times Editorial Team  · 
Biologics

Kyowa Kirin mogamulizumab data show survival gains in rare CTCL

Two indirect treatment comparison analyses link mogamulizumab to significantly lower mortality risk in relapsed mycosis fungoides and Sézary syndrome.
Two indirect treatment comparison analyses link mogamulizumab to significantly lower mortality risk in relapsed mycosis fungoides and Sézary syndrome.
The Biotech Times Editorial Team  · 
Biologics

Junshi Biosciences licenses IL-17A antibody roconkibart to Fosun Wanbang

Junshi Biosciences will receive RMB215m upfront plus milestones and royalties under a Greater China licensing deal for its anti-IL-17A antibody.
Junshi Biosciences will receive RMB215m upfront plus milestones and royalties under a Greater China licensing deal for its anti-IL-17A antibody.
The Biotech Times Editorial Team  · 
Diagnostics
Genomics

Myriad Genetics Prolaris meta-analysis backs prostate cancer staging

A pooled analysis of 8,478 patients shows Myriad's Prolaris Biopsy Test adds prognostic value beyond standard clinical risk tools in localised prostate cancer.
A pooled analysis of 8,478 patients shows Myriad's Prolaris Biopsy Test adds prognostic value beyond standard clinical risk tools in localised prostate cancer.
The Biotech Times Editorial Team  · 
Biologics

Tenax Therapeutics to present LEVEL Phase 3 data at ESC 2026

Topline results from the PH-HFpEF trial of oral levosimendan are expected in August, ahead of a late-breaking session at ESC Congress in Munich.
Topline results from the PH-HFpEF trial of oral levosimendan are expected in August, ahead of a late-breaking session at ESC Congress in Munich.
The Biotech Times Editorial Team  · 
Subscribe to Regulation