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1 week ago | 
pharmatimes.com | John Pinching
The National Institute for Health and Care Excellence (NICE) has recommended FILSPARI (sparsentan) for use in the NHS in England as a treatment for primary IgA nephropathy. The decision follows UK regulatory approval and is based on results from the phase 3 PROTECT trial. NICE’s guidance states that sparsentan can be prescribed to adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more.
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1 week ago | 
pharmatimes.com | John Pinching
With over 55 million people worldwide living with dementia, Oxford Brain Diagnostics (OBD) is set to revolutionise early diagnosis with its patented Cortical Disarray Measurement (CDM®) technology. The software analyses standard MRI scans to provide an objective measure of neurodegeneration, offering a more precise way to assess brain health. Following FDA 510(k) clearance and UKCA self-certification, OBD will now roll out its technology commercially across healthcare sectors in the UK and US.
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2 weeks ago | 
pharmatimes.com | John Pinching
The Board of the Medicines and Healthcare products Regulatory Agency (MHRA) has met in Scotland for the first time, marking a significant step in the agency’s approach to delivering health and innovation priorities across the UK.
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2 weeks ago | 
pharmatimes.com | John Pinching
Sonrai Analytics and AOA Dx have announced a partnership to accelerate the development of AOA’s multi-omic liquid biopsy test for ovarian cancer. The collaboration will use Sonrai’s AI-powered platform to validate diagnostic biomarkers, improving accuracy and clinical utility. AOA will integrate Sonrai’s cloud-based analytics platform to analyse multi-modal data, including multi-omic and clinical information.
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2 weeks ago | 
pharmatimes.com | John Pinching
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved guselkumab (Tremfya) for the treatment of Crohn’s disease and ulcerative colitis (UC). Already used for plaque psoriasis and psoriatic arthritis, guselkumab has shown efficacy in adults with moderately to severely active Crohn’s disease and UC who have not responded to other treatments or experienced unacceptable side effects.
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2 weeks ago | 
pharmatimes.com | John Pinching
Massalia Therapeutics, a biotechnology spin-off from the C2VN Institute, has officially launched with a mission to develop innovative treatments for patients with fibrotic, neoplastic and neovascularized conditions. The company’s sole-in-class therapeutic platform bridges the intersection of these diseases, offering a new approach to tackling their complex interactions.
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3 weeks ago | 
pharmatimes.com | John Pinching
Asgard Therapeutics, a privately held biotech company pioneering in vivo direct cell reprogramming for cancer immunotherapy, has announced the appointment of experienced immunology drug development specialist Shane Olwillas Chief Development Officer (CDO). Shane, who joins Asgard from Pieris Pharmaceuticals, now merged with NASDAQ-listed Palvella Therapeutics, will lead IND-enabling studies and clinical trials planning for Asgard’s lead asset AT-108.
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3 weeks ago | 
pharmatimes.com | John Pinching
AviadoBio has launched its phase 1/2 Aspire-FTD trial in the UK, assessing AVB-101, a gene therapy targeting frontotemporal dementia (FTD) with GRN mutations (FTD-GRN). Cambridge University Hospitals NHS Foundation Trust (CUH) has begun recruiting patients, with University College London (UCL) expected to follow. The Advanced Neurotherapies Centre at Cardiff and Vale University Health Board will provide MRI-guided infusions for UK and international trial participants.
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3 weeks ago | 
pharmatimes.com | John Pinching
Herantis Pharma has dosed the first patients in the final cohort of its phase 1b clinical trial assessing HER-096, a disease-modifying treatment for Parkinson’s disease. The study aims to evaluate the drug’s safety, tolerability and pharmacokinetics while exploring biomarkers linked to the condition. HER-096 is a first-in-class synthetic peptidomimetic designed to mimic cerebral dopamine neurotropic factor (CDNF) protein.
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3 weeks ago | 
pharmatimes.com | John Pinching
Kaerus Bioscience has received orphan drug and rare paediatric drug designations from the FDA for KER-0193, its lead candidate targeting fragile x syndrome (FXS). The announcement follows a successful phase 1 trial confirming the drug’s safety and promising pharmacokinetics. FXS is the most common cause of inherited autism and intellectual disability, affecting approximately 1 in 7,000 males and 1 in 11,000 females. There are currently no approved treatments for the condition.
