Innovation

Digital Health

KPMG UK leads Black Book 2026 NHS EPR consulting scorecard

Black Book ranked 20 NHS EPR consultants across 620 executive inputs, with KPMG UK/EPR Alliance topping the 18-criterion scorecard at 9.57.
Black Book ranked 20 NHS EPR consultants across 620 executive inputs, with KPMG UK/EPR Alliance topping the 18-criterion scorecard at 9.57.
Biotech

Vilnius University virologist names RNA viruses after Baltic gods

Lithuanian virologist Dr Gytis Dudas has named over a dozen newly discovered RNA viruses after Baltic mythology, folklore and even a heavy metal band.
Lithuanian virologist Dr Gytis Dudas has named over a dozen newly discovered RNA viruses after Baltic mythology, folklore and even a heavy metal band.
Digital Health
Diagnostics

RWS launches integrated eCOA linguistic validation service

RWS has combined COA licensing, translation, linguistic validation and rater training under one programme team to cut delays in global clinical trials.
RWS has combined COA licensing, translation, linguistic validation and rater training under one programme team to cut delays in global clinical trials.
Biologics

FDA clears lecanemab subcutaneous autoinjector for Alzheimer's

Eisai and Biogen's LEQEMBI IQLIK autoinjector gains FDA approval as an initiation dose, offering patients a home-use alternative to intravenous infusion.
Eisai and Biogen's LEQEMBI IQLIK autoinjector gains FDA approval as an initiation dose, offering patients a home-use alternative to intravenous infusion.
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.
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.
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.
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.
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.
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.
Digital Health

SHARP launches first health smartwatch using HEALBE FLOW technology

SHARP's Karada Mate Watch integrates HEALBE's bioimpedance-based FLOW platform to estimate calorie intake and hydration automatically.
SHARP's Karada Mate Watch integrates HEALBE's bioimpedance-based FLOW platform to estimate calorie intake and hydration automatically.
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
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.
Digital Health

Vibrant Gastro capsule used in JAMA Psychiatry gut-brain study

UCLA researchers used Vibrant's ingestible vibrating capsule to study gut-brain signalling as a predictor of relapse risk in anorexia nervosa recovery.
UCLA researchers used Vibrant's ingestible vibrating capsule to study gut-brain signalling as a predictor of relapse risk in anorexia nervosa recovery.
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
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