World-first medicine manufacturing regulatory framework to be implemented
The new regulation could become lawful in the UK next year, according to the Medicines and Healthcare products Regulatory Agency (MHRA).
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The new regulation could become lawful in the UK next year, according to the Medicines and Healthcare products Regulatory Agency (MHRA).
Combining allicin with domiphen could reduce biofilm formation, providing a potential avenue for overcoming antimicrobial resistance, research suggests.
The Phase III findings give evidence for the immunotherapy treatment regimen to become standard of care for advanced Hodgkin lymphoma.
The new partnership between Sanofi and Orano Med, delivered via a new entity valued at nearly $2 billion, will focus on progressing lead-212 based targeted alpha therapies for oncology indications.
Dr Sarina Tanimoto, MBA, Co-Founder and Chief Medical Officer of ARS Pharmaceuticals, discusses the company’s EURneffy adrenaline nasal spray as a novel, needle-free option to older approved injectables such as intramuscular injection, following its authorisation in the EU and US.
The US FDA has authorised the first treatment for haemophilia A or B that is administered via a pre-filled pen or syringe.
The draft strategy, open for an eight-week public consultation, will help guide the direction of the network over the next few years.
The new appointee will create AI and machine learning solutions to support Eli Lilly’s medicines for patients globally.
Selecting container closure components with confidence:A data-driven approach to Container Closure Integrity.
CPHI Milan takes place in October, covering a wide range of topics from packaging and drug delivery to integrated pharma.
More than half of the multiple myeloma patients included in this study would have been ineligible for the Phase II CARTITUDE-1 clinical trial, research reports.
Research has highlighted a potential oral drug delivery approach using Quality by Design (QbD) principles to improve treatment of the colonic disease diverticulitis.
Advances in selectivity, safety, and patient convenience, oral small molecule drugs continue to be a key focus in drug development. Here, Dr Andreas Muehler and Daniel Vitt, PhD, the co-founders of Immunic Therapeutics, discuss the potential of Vidofludimus calcium as a breakthrough treatment for autoimmune diseases.
This Feature Partnership discusses AAVs and how manufacturers can overcome the key development challenges and create a scalable AAV production platform.
The new manufacturing facility in Finland will aid global supply of the first FDA-approved intravesical non-replicating gene therapy for adults with a common cancer.