MediBeacon Secures CE Mark Certification for TGFR Monitor and Sensor
MediBeacon announced that its transdermal glomerular filtration rate (TGFR) monitor and reusable sensor have earned CE Mark certification under the EU Medical Device Regulation. The Class IIa devices, part of the broader TGFR system that includes the Lumitrace injection and disposable ring, now meet EU safety and performance standards. The system is already FDA‑approved in the United States and cleared by China’s NMPA, and the CE Mark opens doors for European clinical trials. MediBeacon also highlighted its extensive patent portfolio, with over 250 worldwide patents protecting the technology.
Symeres and Ambagon Collaborate for Colorectal Cancer Molecules
Symeres has partnered with Ambagon Therapeutics to evaluate molecular‑glue compounds for colorectal cancer. The collaboration will leverage Symeres’ in‑vitro assays, surface‑plasmon resonance kinetics, and fluorescence microscopy to characterize ternary‑complex formation and downstream pathway effects. Symeres will also profile each candidate...
UBriGene and Cellinfinity BIO Collaborate to Accelerate in Vivo CAR-T Therapies
uBriGene Biosciences has entered a strategic partnership with Cellinfinity BIO to fast‑track in‑vivo CAR‑T programs for both solid and hematologic cancers. The deal leverages uBriGene’s LVV Turbo platform, which delivers GMP‑grade lentiviral vectors with up to 80% purification recovery and...
Neurophet and ALZ-NET Sign MoU on Alzheimer’s Therapies
South Korean AI firm Neurophet has signed a memorandum of understanding with the Alzheimer’s Network for Treatment and Diagnostics (ALZ‑NET) to build an imaging‑monitoring infrastructure for emerging Alzheimer’s therapies. The deal brings Neurophet’s FDA‑cleared tools—Aqua, Scale PET, and Aqua AD...
MyTomorrows and CUN Partner on AI-Assisted Patient Trial Matching
myTomorrows, a Dutch health‑tech firm, has partnered with Spain’s Clínica Universidad de Navarra (CUN) to embed an AI‑driven clinical‑trial matching engine directly into CUN’s electronic health record. The system leverages large language models to parse multilingual unstructured notes and structured...
Simulations Plus and Three Pharma Companies Collaborate on AI-Driven Drug Development
Simulations Plus has launched strategic partnership programmes with three pharmaceutical companies to embed AI‑driven modelling into the drug development lifecycle. The collaborations will integrate Simulations Plus platforms—ADMET Predictor, GastroPlus, Thales and MonolixSuite—into model‑informed drug development (MIDD) workflows, enabling natural‑language interaction and automated...
Shionogi Enrols First Patients in Esprit Trial for Pompe Disease
Shionogi announced the first patient enrollment in its global Phase II Esprit trial, evaluating the oral substrate‑reduction therapy S‑606001 in adults with late‑onset Pompe disease. The 52‑week, double‑blind, placebo‑controlled study will run across the EU, the UK and the United States,...
Epic Secures a £222m Federated EPR Contract Across Somerset and Dorset
In early March 2026 four NHS trusts in Somerset and Dorset signed a £222 million federated contract with US‑based Epic to replace a patchwork of legacy electronic patient record (EPR) and patient‑administration systems. The deal unifies Epic’s platform across Somerset NHS...
OXOS Medical’s MC2 Secures Clearance for Paediatric Imaging
OXOS Medical announced FDA clearance for its MC2 portable X‑ray system designed specifically for paediatric imaging. The lightweight, wireless device enables bedside scans, allowing children to stay with caregivers while receiving low‑dose, high‑definition images. Hands‑free operation via a wireless foot...
START and Trialing Collaborate on Oncology Clinical Trials
START Center for Cancer Research has partnered with Trialing to broaden access to early‑phase oncology clinical trials throughout Europe. The exclusive agreement lets START distribute curated trial information and real‑time enrollment updates via Trialing’s platform, directly notifying oncologists when slots...
GEN Secures BEBO Foundation Approval for Phase II PD Trial
GEN Pharmaceuticals received BEBO Foundation ethical approval to launch a Phase II proof‑of‑concept trial of its mitochondrial‑targeting drug SUL‑238 in Parkinson’s disease. The single‑centre, randomised, double‑blind, placebo‑controlled study, named SHEPHERD, will begin patient enrolment in Groningen in April 2026. Over a 28‑day...
KORU Medical Secures Certification Under EU MDR for Infusion Pump
KORU Medical has obtained European Union Medical Devices Regulation (EU MDR) certification for its Freedom60 infusion pump, which includes an adapter for 50 ml prefilled syringes, allowing commercialisation across the EU. The pump complements the FreedomEDGE system that supports 20 ml cartridges,...
J&J Reports Positive Data for Erda-iDRS in Bladder Cancer
Johnson & Johnson announced encouraging Phase I data for its intravesical drug‑releasing system Erda‑iDRS in non‑muscle‑invasive bladder cancer (NMIBC) with FGFR alterations. The trial met its primary safety endpoint and delivered an 89% complete response rate in intermediate‑risk patients, with responses...
PsiQuantum and National Cancer Center Japan Partner on Quantum Computing
PsiQuantum and Japan’s National Cancer Center have signed a research agreement to explore utility‑scale quantum computing for oncology drug discovery. The collaboration will focus on developing fault‑tolerant quantum algorithms and deploying PsiQuantum’s Construct platform across the healthcare value chain. Additional...
Pilatus Biosciences Doses First Patient in PLT012 Antibody Trial
Pilatus Biosciences has begun dosing the first patient in a Phase I, open‑label trial of PLT012, its first‑in‑class anti‑CD36 monoclonal antibody, at Next Oncology in Houston. The FDA recently issued IND clearance along with orphan‑drug status for hepatocellular carcinoma and fast‑track...
Abbott Reports Positive FreeDM2 Study Results for CGM
Abbott announced that its FreeStyle Libre continuous glucose monitoring system outperformed traditional finger‑stick testing in the FreeDM2 randomised trial involving 303 UK patients with type 2 diabetes on basal insulin. After four months, CGM users achieved a larger reduction in HbA1c...
Olympus Unveils VISERA ELITE III Platform to Improve Surgical Visualisation
Olympus has introduced the VISERA ELITE III surgical imaging platform in the United States, the third joint offering from the Sony‑Olympus Medical partnership. The system combines continuous auto‑focus, true 4K, 3D, narrow‑band and fluorescence (IR/ICG) imaging in a single software‑driven unit that...
Gesynta Pharma Doses First Patient in Phase II NOVA Trial
Gesynta Pharma has begun dosing the first patient in its Phase II NOVA trial, evaluating oral vipoglanstat for endometriosis. The double‑blind, placebo‑controlled study will enroll about 190 women across Europe and compare two dose levels against placebo over four menstrual cycles....
QT Imaging Secures FDA Clearance for Updated Breast Acoustic CT Scanner
QT Imaging has secured FDA 510(k) clearance for an updated Breast Acoustic CT scanner, a 3‑D ultrasound tomographic system designed to improve visualization of posterior breast tissue. The new configuration features a tilted transmitter geometry that expands coverage near the...
Kainova Reports Positive Top Line Results From Phase I EPRAD Trial
Canada‑based Kainova Therapeutics announced positive top‑line results from its Phase I EPRAD study of DT‑9081, an oral EP4 receptor antagonist, in patients with advanced, recurrent and metastatic solid tumours. The trial, conducted at four sites in Belgium and France, met all...
LifeVac Receives FDA De Novo Classification for Anti-Choking Device
LifeVac has secured FDA De Novo classification, designating its suction anti‑choking device as a Class II medical device for second‑line treatment after failed basic life support protocols. The clearance confirms the device as a single‑use, non‑powered, non‑invasive tool suitable for adults and...
Aisa Pharma Reports Positive Results for AISA-021
Aisa Pharma announced positive Phase II data for AISA‑021, a once‑daily calcium channel blocker, in systemic sclerosis‑associated Raynaud’s phenomenon (SSc RP). The double‑blind, placebo‑controlled RECONNOITER trial enrolled 64 patients and showed a 22.1% reduction in weekly Raynaud attacks and a 155% placebo‑adjusted...
Seqster Unveils 1-Click DataLake for Clinical Trials
Seqster has introduced 1‑Click DataLake, a real‑world data platform that aggregates anonymized electronic health‑record information from over 150 million patients and 200,000 clinicians across the United States. The solution delivers real‑time, longitudinal patient journeys to speed trial design, feasibility assessments, and...
Liberate Bio Gains Licences for Myeloid-Specific CAR Design Patents
Liberate Bio announced it has secured both exclusive and non‑exclusive licenses to patents covering chimeric antigen receptor (CAR) designs engineered for myeloid cells such as monocytes and macrophages. The licences broaden the company’s intellectual‑property portfolio beyond traditional T‑cell CAR platforms,...
Philips Launches Rembra CT System for Acute Imaging
Philips has introduced Rembra, a next‑generation CT system built for acute and high‑throughput imaging environments. The scanner delivers ultra‑fast reconstruction speeds of up to 106 images per second and can support as many as 270 examinations per day. It features...
HUTCHMED Begins Phase I/IIa Trial of HMPL-A580 for Solid Tumours
HUTCHMED has launched a first‑in‑human Phase I/IIa trial of HMPL‑A580, its second antibody‑targeted therapy conjugate, in the United States and China. The multi‑centre, open‑label study will evaluate safety, tolerability, immunogenicity, pharmacokinetics and early efficacy across dose‑escalation and expansion cohorts. HMPL‑A580...
Affinia Receives FDA Fast Track Designation for AFTX-201
Affinia Therapeutics announced that the FDA has granted fast‑track designation to its gene‑therapy candidate AFTX‑201 for BAG3‑associated dilated cardiomyopathy. The one‑time intravenous treatment delivers a full‑length BAG3 transgene via an engineered capsid that requires doses five to ten times lower...
FDA Grants PMA to Synergy’s Cervical Disc
Synergy Spine Solutions received FDA pre‑market approval for its Synergy Disc, a cervical artificial disc designed to preserve motion and correct spinal alignment. Clinical data showed an 87.1% composite success rate at 24 months, with significantly lower neck‑pain and arm‑pain...
Opus Genetics Reports Phase I/II Trial Results of OPGx-BEST1 Gene Therapy
Opus Genetics presented early Phase I/II data for its OPGx‑BEST1 gene therapy targeting best vitelliform macular dystrophy and autosomal‑recessive bestrophinopathy. In a sentinel 63‑year‑old participant, the treatment was well tolerated and delivered a 12‑letter gain in best‑corrected visual acuity after...
ENDRA Reports Favourable Data From Taeus Liver Device Study in MASLD
ENDRA Life Sciences announced that its Taeus Liver device achieved high measurement consistency in a MASLD study, recording an intraclass correlation coefficient of 0.89 and a standard error of measurement of 3.3%. The trial involved 14 participants and 56 data...
Lilly Reports ACHIEVE-3 Trial Outcomes for Type 2 Diabetes
Eli Lilly disclosed Phase III ACHIEVE‑3 results showing its oral GLP‑1 agonist orforglipron outperformed oral semaglutide in lowering A1C and inducing weight loss. The 52‑week, open‑label trial enrolled 1,698 patients across six countries and compared two doses of each drug. Orforglipron also...
Mahzi Doses First Patient in MZ-1866 Trial for Pitt Hopkins Syndrome
Mahzi Therapeutics has administered the first dose of its investigational gene therapy MZ-1866 in the Phase I/II UNITE study for Pitt‑Hopkins syndrome. The open‑label, multicentre trial will enroll roughly 12 genetically confirmed patients across sites in Spain, Israel and the...
Stryker Unveils Synchfix EVT for Flexible Syndesmotic Ankle Fixation
Medical device maker Stryker has launched Synchfix EVT, a flexible syndesmotic fixation system designed to simplify ankle stabilization procedures. The all‑in‑one, single‑use device integrates suture tensioning handles and a low‑profile titanium medial implant, reducing procedural complexity for both adult and adolescent...
Vico Therapeutics Initiates Patient Dosing for VO659 Phase I/IIa Trial
Vico Therapeutics has initiated patient dosing in an expanded European cohort for its Phase I/IIa VO659 trial, targeting Huntington's disease, spinocerebellar ataxia type 3 and type 1. The study employs a twice‑annual intrathecal regimen and will monitor safety, tolerability, pharmacodynamics and pharmacokinetics...
NorthX Biologics and Demeetra Collaborate on GMP Manufacturing and CLD
NorthX Biologics and Demeetra have formed a strategic alliance to provide an end‑to‑end solution that couples Demeetra’s CleanCut CHO cell line development platform with NorthX’s GMP manufacturing capabilities. The partnership leverages a high‑titre GS‑knockout CHO cell line that carries no...
FDA Approves Allurion’s PMA Application for Gastric Balloon System
Allurion received FDA clearance for its Gastric Balloon System featuring the Smart Capsule, a swallow‑able, endoscopy‑free obesity treatment. The capsule is placed during a 15‑minute office visit, inflates in the stomach for about four months, then exits naturally, with a...
J&J Reports Long-Term QUASAR Data for Tremfya in Ulcerative Colitis
Johnson & Johnson released long‑term QUASAR extension data for Tremfya (guselkumab) in ulcerative colitis, showing sustained efficacy through week 140. Clinical remission was achieved by 80.8% of patients, with 78.6% attaining histo‑endoscopic improvement and 53.6% reaching endoscopic remission. Approximately 89% of...
AngioDynamics Expands European Indications for NanoKnife System
AngioDynamics announced that its NanoKnife system now holds European CE‑mark indications for soft‑tissue ablation of liver, kidney, prostate and pancreas tumours, including intermediate‑risk prostate cancer. The device uses irreversible electroporation (IRE), a non‑thermal technology that destroys cancer cells while sparing...
Serina Therapeutics Enrols First Patient for SER-252 Trial
Serina Therapeutics has enrolled the first patient in its Phase Ib registrational trial of SER‑252 for advanced Parkinson’s disease. The study, conducted with Parkinson’s Australia and Neuroscience Trials Australia, will assess safety, pharmacokinetics, tolerability and early efficacy, with dosing slated to...
Syngene and VivaMed Collaborate on Therapeutic Programmes
Syngene International has entered a strategic collaboration with VivaMed BioPharma to advance AI‑derived drug repurposing programmes. The partnership combines Syngene’s pre‑clinical development capabilities with VivaMed’s AI‑generated therapeutic hypotheses, creating a pathway from computational hits to translational validation. Together they will...
MSD and Mayo Clinic Team up to Advance AI in Drug Development
Merck (MSD) and Mayo Clinic have launched a research partnership that blends Mayo's Platform architecture and multimodal clinical‑genomic data with MSD's virtual‑cell technologies. The collaboration gives MSD direct access to de‑identified imaging, lab, molecular and notes data to train and...
Portal Diabetes’ Insulin Pump Receives FDA Breakthrough Device Designation
Portal Diabetes has secured FDA breakthrough device designation for its implantable Portal Pump, an insulin delivery system that pairs an abdominal pump with continuous glucose monitoring and concentrated insulin. The company also launched a Phase I study of temperature‑stable Portal Insulin...
Janux Commences Participant Dosing in Phase I JANX011 Trial
Janux Therapeutics has dosed the first participant in a Phase I, open‑label, dose‑escalation trial of JANX011, its inaugural candidate from the adaptive immune response modulator (ARM) platform. The bispecific antibody targets CD19‑expressing B cells to achieve a deep, lasting immune reset...
J&J’s Rybrevant Faspro Gains FDA Approval for New Dosing in NSCLC
Johnson & Johnson received FDA approval for a once‑monthly subcutaneous regimen of Rybrevant Faspro combined with Lazertinib for first‑line treatment of advanced EGFR‑mutated non‑small cell lung cancer. The new schedule delivers clinical outcomes comparable to the earlier bi‑weekly dosing while preserving...
VB Spine to Acquire Xvision Spine System From Augmedics
VB Spine has signed a definitive agreement to acquire Augmedics' xvision Spine System, adding augmented reality navigation to its enhanced visualization suite. The FDA‑cleared platform, already used in nearly 13,000 procedures, offers direct patient visualization, workflow efficiency, and reduced radiation...
CStone Secures FDA Clearance to Begin CS2009 Phase II Trial
CStone Pharmaceuticals has secured FDA clearance for its investigational new drug application, allowing the launch of a Phase II trial of CS2009, a trispecific antibody that simultaneously targets PD‑1, VEGFA and CTLA‑4. The global study uses a parallel, multi‑cohort expansion design...
ExCellThera Secures German NUB Status 1 Listing for Zemcelpro
ExCellThera and its subsidiary Cordex Biologics have secured a Status 1 listing under Germany’s NUB programme for their cell therapy Zemcelpro (dorocubicel). The therapy, which received conditional marketing authorisation from the European Commission, targets adults with haematological malignancies lacking suitable donor...
Novartis Reports Final Data of ALIGN Trial in IgAN
Novartis released final Phase III ALIGN data showing its oral endothelin‑A antagonist Vanrafia (atrasentan) slowed kidney function decline in adults with IgA nephropathy. The double‑blind, placebo‑controlled trial enrolled 340 biopsy‑confirmed patients who continued optimized RAS inhibition, delivering a 2.39 ml/min/1.73 m² advantage in...
Medtronic Secures FDA Approval for Stealth AXiS Spine Robotics Platform
Medtronic has secured FDA clearance for its Stealth AXiS spine‑surgery robotics platform, an integrated solution that combines robotics, planning and navigation in a single workflow. The system features LiveAlign segmental tracking, delivering real‑time visualization of anatomical movement and reducing the need...
Immunic Secures $400m Fund to Support Commercial-Stage Development
Immunic announced an oversubscribed private placement that could raise up to $400 million, led by BVF Partners and other institutional investors. The capital will fund the completion of the Phase III ENSURE trial of vidofludimus calcium in relapsing multiple sclerosis, with topline...