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Preventative approach could reduce immunotherapy side effects
Research suggests that giving prophylactic treatment prior to immunotherapy could eliminate the need for the latter to be administered in hospitals.
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Therapeutics
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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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Regulatory revision essential for bioprocess IIoT adoption
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.
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Outsourcing regulatory activities in pharma
Here, EPR's Caroline Peachey explores some key considerations, approaches and strategies for pharmaceutical companies looking to outsource regulatory activities.
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Boehringer Ingelheim agrees $2bn siRNA therapeutic collaboration
The collaboration seeks to develop new siRNA treatments for the liver diseases nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH).
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MHRA authorisation is first endocrine therapy innovation in decades
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).
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Driving QbD as a quality standard in drug development
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.
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Financial factors to support and challenge Pharma in 2024
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.
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AstraZeneca to advance haematology cell therapy
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.
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BMS strikes $14bn deal for Karuna Therapeutics
The deal includes Karuna Therapeutics' potential first-in-class antipsychotic, xanomeline-trospium, for patients with schizophrenia and other conditions.
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Sanofi stops development of lung cancer drug
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.
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Bioburden and sterility testing: how to conserve gene therapy product
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.
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Year in review: EPR’s top stories of 2023
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.
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Psilocybin-assisted therapy reduces depressive symptoms in cancer patients
Results from a Phase II clinical trial indicate that psilocybin-assisted therapy could benefit individuals with cancer and major depression.
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CHMP issues positive option for first gene-editing medicine
If approved, Vertex’s Casgevy (exagamglogene autotemcel) would be the first gene-editing medicine authorised in the European Union.
