European Commission extends approval of cystic fibrosis medicine
For the first time, a medicine to treat the most common form of cystic fibrosis has been approved in paediatric patients aged one to under two years old.
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For the first time, a medicine to treat the most common form of cystic fibrosis has been approved in paediatric patients aged one to under two years old.
Welcome to EPR's Guide to Data Integrity. In this edition, Charles River explores the significance of data integrity in pharmaceutical manufacturing, Graeme Bones of ICON considers how to complete database transfer with data integrity considerations at the forefront and Rapid Micro Biosystems® discusses the practical implications of the ‘four-eyes principle’ for pharma…
"Development of a novel oral therapy that specifically targets IL-23R could potentially change the treatment paradigm” in moderate-to-severe plaque psoriasis (PsO), stated a Janssen R&D VP.
Evaluation of bacterial endotoxin pyrogens is included in the International Organization for Standardization (ISO)’s new standard for microbiological methods.
This in-depth focus features articles on trends in capsule formulation and the evolving role of titanium dioxide in formulation.
Raquera Brown, Executive Director of Quality at Zymeworks offers quality and compliance professionals advice on how to navigate the often-complex regulatory space during development of innovative drugs like antibody therapeutics.
A novel PPAR alpha/delta agonist “could provide an important new therapeutic option for long-term treatment [of primary biliary cholangitis (PBC)].
There continues to be a correlation between low site inspection scores and potential drug recalls, states the US Office of Pharmaceutical Quality (OPQ) 2022 annual report.
Digitalisation is a driving factor for the global process analytical technology (PAT) market, according to a report.
This in-depth focus explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry and the power of rapid methods for fungal ID.
The first approved gene therapy for haemophilia A reduced the mean annualised bleeding rate from 5.4 bleeds to 2.6 bleeds per year in a clinical study.
US Food and Drug Administration (FDA)-approved allogeneic pancreatic islet cell therapy Lantidra could provide another treatment option for Type 1 diabetes.
Insilico Medicine’s novel AI-generated small molecule inhibitor drug represents a new milestone in pharmaceutical drug development.
Mirikizumab, the first therapeutic antibody tested for blocking interleukin-23 in ulcerative colitis has demonstrated strong efficacy in two Phase III trials.
Since the US Food and Drug Administration (FDA)’s report on a series of nitrosamine-related impurity drug recalls in 2018, pharma has made great strides in its ability to detect and control for these impurities. Dr Mrunal Jaywant, Vice President of R&D at USP India proposed a collaborative, cross-community approach between…