Regulation

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.
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.
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.
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.
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.
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.
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.
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.
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.

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.
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
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.
Biotech

BellaSeno pivotal trial enrols 30 women for absorbable breast scaffold

The Leipzig-based regenerative medtech firm reports 83% mean breast volume retention and zero scaffold-related complications in its first-in-human safety cohort.
The Leipzig-based regenerative medtech firm reports 83% mean breast volume retention and zero scaffold-related complications in its first-in-human safety cohort.
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.
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.
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.
Diagnostics

IBA wins contract to install Portugal's first proton therapy centre

Belgian particle accelerator firm IBA will supply two Proteus ONE compact systems to IPO-Porto, establishing the country's first proton therapy facility by 2029.
Belgian particle accelerator firm IBA will supply two Proteus ONE compact systems to IPO-Porto, establishing the country's first proton therapy facility by 2029.
Biologics

Xeltis passes 50% enrollment in US pivotal trial for aXess graft

The Netherlands-based medtech has enrolled over 70 patients across 20 US sites for its bioabsorbable hemodialysis vascular access device.
The Netherlands-based medtech has enrolled over 70 patients across 20 US sites for its bioabsorbable hemodialysis vascular access device.
Biologics

Abivax prices upsized $800M ADS offering to fund obefazimod launch

The Paris-listed biotech upsized its US public offering from $600M to $800M, extending its cash runway to Q2 2029 ahead of a potential obefazimod
The Paris-listed biotech upsized its US public offering from $600M to $800M, extending its cash runway to Q2 2029 ahead of a potential obefazimod
Genomics

Roche divarasib beats first-gen KRAS G12C drugs in Phase III NSCLC trial

Roche's Krascendo 1 study showed divarasib improved both progression-free and overall survival versus sotorasib or adagrasib in previously treated KRAS G12C lung cancer
Roche's Krascendo 1 study showed divarasib improved both progression-free and overall survival versus sotorasib or adagrasib in previously treated KRAS G12C lung cancer
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