Novel drug delivery method shows promise in Alzheimer’s
Ultrasound combined with a biologic treatment has demonstrated the ability to safely reduce brain amyloid plaques in the brains of Alzheimer’s patients, a first-in-human study shows.
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Ultrasound combined with a biologic treatment has demonstrated the ability to safely reduce brain amyloid plaques in the brains of Alzheimer’s patients, a first-in-human study shows.
A limited number of Industrial Internet of Things (IIoT) applications exist in the bioprocessing industry and remain to be challenged in manufacturing operations, research has highlighted.
Here, EPR's Caroline Peachey explores some key considerations, approaches and strategies for pharmaceutical companies looking to outsource regulatory activities.
The collaboration seeks to develop new siRNA treatments for the liver diseases nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH).
A new breast cancer treatment that reduced the risk of progression or death by 45 percent compared to standard of care in a Phase III trial, has been authorised by the UK Medicines & Healthcare products Regulatory Agency (MHRA).
To facilitate Quality by Design (QbD) in becoming a true standard approach for drug development, pharma should attend regulatory expectations and pursue innovative frameworks that guarantee high-quality levels, researchers urge.
While constraints such as inflation and drug pricing pressures will impact pharma’s growth in 2024, patent expiration of biologics is expected to support the industry over the next few years, research suggests.
The new acquisition grants AstraZeneca rights to a new CAR-T cell therapy with a differentiated manufacturing process that could provide a potential best-in-class blood cancer treatment.
The deal includes Karuna Therapeutics' potential first-in-class antipsychotic, xanomeline-trospium, for patients with schizophrenia and other conditions.
Sanofi is discontinuing development of tusamitamab ravtansine for certain types of non-small cell lung cancer after a Phase III clinical trial did not meet its endpoint.
Here, Kathy Zagaroli, Senior Director of Quality Control at Kiniksa Pharmaceuticals, and Tom Bujold, Senior Director of Quality Control at REGENXBIO, discuss the challenges of bioburden and sterility testing for gene therapies and why industry must come together to drive increased harmonisation.
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
Results from a Phase II clinical trial indicate that psilocybin-assisted therapy could benefit individuals with cancer and major depression.
If approved, Vertex’s Casgevy (exagamglogene autotemcel) would be the first gene-editing medicine authorised in the European Union.
Samantha Lane, Head of Research for the Centre of Pharmacovigilance Sciences at the Drug Safety Research Unit discusses drug product withdrawals and the regulatory shift to a greater reliance on epidemiological and observational research as evidence for these decisions within Europe.