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Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research

Advarra

The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms. Non-EU companies must comply with the AI Act if their AI systems are used in the EU market.

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What are the opportunities for decentralised clinicial trials?

Drug Discovery World

The logistics of DCTs The number of clinical trials being conducted via the DCT and hybrid model has increased significantly in recent years, and the pace of change shows no sign of slowing. The market, worth an estimated $8.8 billion, by 2026 1. billion in 2021 is expected to increase by 10% year on year, to $14.2

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Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. The study is planned to begin in 2026 and conclude in 2028. Read AgencyIQ analysis here for a detailed discussion of these issues. ]. See AgencyIQ’s analysis of the draft guidance here. ].

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From cradle to grave: Novo Nordisk Foundation and cardiometabolic diseases 

Drug Discovery World

billion) in 2023, 51% higher than 2022, marking the company’s largest annual net profit going back to 1989, according to data from S&P Global Market Intelligence 1. According to the Washington Post 2 , Novo Nordisk turned an annual profit of 83.7 billion DKK ($11.97 million).

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Scaling up: The need for human cells to give better access to cell therapies

Drug Discovery World

And it’s not just bit.bio – there are many other companies exploring different cell types within clinical research. Challenges “There are some cell therapies on the market but the cost of those is maybe $500,000 a dose. One of these is cost, driven largely by the bespoke and expensive manufacturing processes.

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Sequana Medical to present at Jefferies 2020 Virtual London Healthcare Conference

The Pharma Data

market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfa pump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. In the U.S., and Canada.

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Sequana Medical Announces January 2021 Investor Conference Schedule

The Pharma Data

market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfa pump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. In the U.S., and Canada.