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”
Category: Industry news
The latest news from the Pharmaceutical Industry
The US FDA have finalised two guidances on guidewires, catheters and delivery systems
The United States (US) Food and Drug Administration (FDA) have issued two final guidances regarding performance tests and labelling considerations for intravascular guidewires, catheters and delivery systems. Read more “The US FDA have finalised two guidances on guidewires, catheters and delivery systems”
Highlights from the recent PRAC meeting
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) have unveiled highlights of their meeting from 30th September – 3rd October 2019. Read more “Highlights from the recent PRAC meeting”
How would an international price index (IPI) work to lower drug prices in the US?
House speaker Nancy Pelosi has unveiled a plan to lower sky-high prescription drug prices in the United States (US). Read more “How would an international price index (IPI) work to lower drug prices in the US?”
Are you aware of the Department of Health and Social Care’s (DHSC) work with the industry on plans to minimise any medical supply disruption following a no-deal Brexit?
The Medicines and Healthcare Regulatory Agency (MHRA) have released guidance summarising their approach and actions to be taken by businesses supplying the United Kingdom (UK) with medicines from the European Union (EU), Iceland, Lichtenstein or Norway. Read more “Are you aware of the Department of Health and Social Care’s (DHSC) work with the industry on plans to minimise any medical supply disruption following a no-deal Brexit?”
MHRA update their no-deal Brexit Guidance for medical devices
The United Kingdom’s (UK’s) Medicines and Healthcare products Regulatory Agency (MHRA) have added a new section to their “no-deal Brexit” guidance for medical devices, regarding the “UK Responsible Person”. Read more “MHRA update their no-deal Brexit Guidance for medical devices”
What is KASA and how will it affect you? FDA explains plans for the new pharmaceutical quality assessment system
The US Food and Drug Administration (FDA) has been developing a new pharmaceutical quality assessment system known as the Knowledge-aided Assessment & Structured Application (KASA). Read more “What is KASA and how will it affect you? FDA explains plans for the new pharmaceutical quality assessment system”
Did you know that the EMA and the US FDA are aligned in more than 90% of marketing authorisation decisions for new medicines?
One of the findings of a joint European Medicines Agency (EMA) and Food and Drug Administration (FDA) analysis compared decisions on 107 new medicine applications at the two agencies for the period 2014 to 2016. The majority of the information used for the study was sourced from EMA’s publicly available European Public Assessment Reports (EPARs) and FDA reviews. Read more “Did you know that the EMA and the US FDA are aligned in more than 90% of marketing authorisation decisions for new medicines?”
FDA finalises guidance on designing nonclinical studies and product labelling for radiopharmaceuticals used in oncology
The United States (US) Food and Drug Administration (FDA) have finalised their guidance on designing nonclinical studies and product labelling for radiopharmaceuticals used in oncology. Read more “FDA finalises guidance on designing nonclinical studies and product labelling for radiopharmaceuticals used in oncology”
British Pharmacopoeia and the United States Pharmacopeia formalise partnership to strengthen the quality of medicines and public health
The British Pharmacopoeia (BP) and United States Pharmacopeia (USP) have signed a memorandum of understanding which formalises their partnership to strengthen quality standards for medicines. Read more “British Pharmacopoeia and the United States Pharmacopeia formalise partnership to strengthen the quality of medicines and public health”