An overview of the opportunities and challenges posed by bringing clinical trials into the domain of big data

The Clinical Trial and Imaging Subgroup of the European Medicines Agency (EMA) has released a report on the issues associated with the combination of data from different clinical trials into large datasets. Read more “An overview of the opportunities and challenges posed by bringing clinical trials into the domain of big data”

The EMA has published important guidance on the clinical development of new gout treatments

The finalised guidelines show the European Medicines Agency’s (EMA) expectations of manufacturers involved in the clinical development of new urate-lowering therapies (ULTs) and anti-inflammatory treatments of gout. Read more “The EMA has published important guidance on the clinical development of new gout treatments”

The latest advancements on the use of artificial intelligence in drug development

Approximately 50% of late-stage clinical trials fail due to ineffective drug targets, meaning only 15% of drugs advance from Phase II trials to approval. Artificial intelligence (AI) can help to enhance drug development by making more accurate predictions in novel areas of biology and chemistry. Read more “The latest advancements on the use of artificial intelligence in drug development”

How can drug development be augmented for the treatment of hepatitis D?

Hepatitis D (HDV) is a replication-defective viral infection that uses the hepatitis B (HBV) surface antigen as its envelope protein. HDV infection can be associated with severe liver disease which can lead to cirrhosis, hepatocellular carcinoma and liver failure. Presently, there are no drugs approved for the treatment of this life-threatening disease. Read more “How can drug development be augmented for the treatment of hepatitis D?”

What is considered Good Practice on the assessment of GMO aspects for in-vivo gene therapy products?

A recent document released by the European Commission (EC) outlines Good Practice considerations when assessing genetically modified organism (GMO) related aspects, during the conduct of clinical trials with Adeno-associated virus (AAV) vectors. Read more “What is considered Good Practice on the assessment of GMO aspects for in-vivo gene therapy products?”

MHRA publishes guidance on comparator products to be used in bioequivalence and therapeutic equivalence studies, in the event of a no-deal Brexit

In the event of a no-deal Brexit, reference medicinal products (RMP) for new generic medicines or abridged marketing authorisation applications will be required to comply with the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (HMRs). Comparator products (CP) used in these applications will need to be representative of the RMP. Read more “MHRA publishes guidance on comparator products to be used in bioequivalence and therapeutic equivalence studies, in the event of a no-deal Brexit”