Rare disease drugs get boost from new NICE guidelines
NICE has raised the cost-effectiveness thresholds for ultra-rare disease drugs under its Highly Specialised Technology programme – a move welcomed by patient advocates and biotech leaders.
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NICE has raised the cost-effectiveness thresholds for ultra-rare disease drugs under its Highly Specialised Technology programme – a move welcomed by patient advocates and biotech leaders.
The Eurofins Assurance network has secured ISO/IEC 17065:2012 accreditation from ANAB for its Good Manufacturing Practices (GMP) certification programme.
AI is increasingly used in drug discovery, but hidden bias and ‘black box’ models threaten trust and transparency. This article explores how explainable AI can turn opaque predictions into clear, accountable insights.
Gene therapy’s progress depends on reliable supply chains and efficient manufacturing. In this episode, we explore the challenges and strategies involved in plasmid production - an essential component in advancing life-changing therapies.
Eurofins Healthcare Assurance is expanding into China to better serve key industries with local expertise. This move strengthens their commitment to quality assurance and regulatory services on a global scale.
The potential for brain organoids to develop consciousness is a key issue in neuroscience, which has prompted new ethical considerations.
Bare minimum reimbursement rates could be why some clinics may be struggling to offer HPV vaccination in the US.
Japanese researchers debate if human brain organoids that are cultivated from stem cells and serve as a model of human brain development, can be legally considered a person.
The College of American Pathologists has given accreditation to Altasciences’ clinical site in Los Angeles, California.
Incannex Healthcare has completed a pre-IND meeting with the FDA for IHL-216A, a drug product for treatment of traumatic brain injury.
Following FDA clearance, Cellenkos will initiate Phase I and Phase Ib trials of CK0803, allogeneic regulatory T cells, in patients with ALS.
Texas Biomed and The Access to Advanced Health Institute have been granted $3.5 million to initiate tuberculosis vaccine research, which includes using genetically diverse animal models.
The Chinese National Medical Products Administration has approved a Phase Ib study of Everest Medicines' EVER001, for potential treatment of glomerular diseases.
Decibel Therapeutics has submitted an IND application for a Phase I/II trial of DB-OTO, a gene therapy candidate to restore hearing.
Silo Pharma says it is preparing a pre-IND package and meeting with the FDA for a topical formulation of ketamine to treat fibromyalgia.