The need for cross-sectoral, global cooperation to fight antimicrobial resistance

The statement emphasises the role of medicines regulators in efficiently bringing safe, effective and high quality antimicrobial products to the market, as well as minimising the regulatory barriers which can prevent access to essential treatments. Read more “The need for cross-sectoral, global cooperation to fight antimicrobial resistance”

ICH survey shows greater regulatory harmonisation among pharmaceutical companies and regulators

The results of a recent survey released by the International Council on Harmonisation (ICH) suggest that pharmaceutical companies and regulators around the world are adopting and adhering to its guidelines on quality, safety and efficacy in drug development. Read more “ICH survey shows greater regulatory harmonisation among pharmaceutical companies and regulators”

The FDA plans to implement e-submission of safety reports for investigational new drug (IND) applications

The United States (US) Food and Drug Administration (FDA) is taking steps towards making electronic submission of safety reports for investigational new drug applications (INDs) into their Adverse Event Reporting System (FAERS), a requirement. Read more “The FDA plans to implement e-submission of safety reports for investigational new drug (IND) applications”

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?”