Research & Development

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

The US precision medicine company hopes its drug response predictor technology will enhance responses to the chemotherapy Ixempra on the basis of promising data from a handful of breast cancer patients in a Phase II trial, marking a positive turn in its journey to date.  

Value-added medicines specialist Hyloris has struck a deal worth up to €4.3m with Purna Female Healthcare to develop a treatment for vulvovaginal candidiasis that combines miconazole and domiphen bromide.

Tumor infiltrating lymphocyte therapies show promise for solid tumors, with a first FDA approval, but face manufacturing and access challenges as development continues.

The sixth annual edition of In Vivo’s Rising Leaders features entrepreneurs, academics, lawyers, regulators and innovators from around the globe, representing the forefront of creativity in health care.

A disastrous Phase II miss for the pulmonary arterial hypertension candidate AV-101 leaves Aerovate drifting. Could Gossamer stand to benefit?    

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.  

GLP-1 receptor agonists could play a big role in tackling neurodegeneration and a new academic study has raised expectations of Novo Nordisk’s latest semaglutide Phase III results

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

Attendees at this year's European Society for Medical Oncology meeting in Barcelona can look forward to a range of interesting datasets, from Phase III trials of established products in new settings to preliminary studies of novel products coming through the pipeline.  

The commercial implications of the miss are hard to call, but separate trials could offer hope.    

Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.

Francesco Hofmann, head of R&D at the mid-sized French group, tells Scrip that its strategy of not playing in the spaces that are dominated by big pharma is paying off.

Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second.

Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second

Biopharmaceutical giant AstraZeneca has partnered with start-up “unicorn” Owkin to develop an AI-powered tool to prescreen for gBRCA mutations on the basis of morphological features in digitized pathology slides. Built on extensive, high-quality data sourced from the France-based PortrAIt consortium, the AI will help to prioritize patients for further testing, streamlining the diagnostic process, Owkin says.

An additional $50m brings the neurovascular intervention specialist’s total Series F funding to $82m. Route 92 says it will use the capital to build its sales and support teams and pursue regulatory authorizations around the globe for its FreeClimb portfolio while advancing its SUMMIT MAX clinical trial for the investigational Monopoint Reperfusion System.

TRiCares announced first implantation of the Topaz transfemoral tricuspid heart valve replacement system as part of the company’s EU pivotal study. If all goes to plan, the device will compete with Edwards’ Evoque system. The announcement follows the company’s $50m series D funding raise in July.

J&J acquired Taris in 2019 to gain access to TAR-200 and its drug delivery platform. Now, early clinical data suggest the product could delay or remove the need for cystectomy in several bladder cancer settings and the US healthcare giant is eyeing multi-blockbuster sales.