International
While regulators are “catching up” to the use of artificial intelligence in clinical development, some skepticism remains around the use of AI to generate synthetic patient data, says Alexion’s Nick France.
Artificial intelligence in pharmaceutical manufacturing is increasing in prevalence, offering a unique opportunity for global regulators to align on expectations, industry group IFPMA says.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Decentralized trial tools are settling into routine use as sponsors and sites apply them selectively to address protocol-specific operational needs, say Pamela Tenaerts and Kenneth Getz.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
The European Medicines Agency said that Acoziborole Winthrop would simplify the treatment of first- and second-stage disease caused by Trypanosoma brucei gambiense.
A new regulatory reliance procedure in New Zealand is expected to better allow companies to include the country in their global drug launch plans more easily.
Acoziborole, developed by Sanofi in collaboration with the Drugs for Neglected Diseases initiative, could potentially become the first single-dose oral treatment for sleeping sickness.
Iloperidone is among 13 new drugs that the European Medicines Agency is set to consider this week, as it decides whether they should be granted marketing approval.
The use of animal testing alternatives in drug R&D has reached a “tipping point” which is driving a faster pace of acceptance among regulators and industry, an expert says. In addition, a senior figure at AstraZeneca explains how it is using NAMs to accelerate drug discovery.
Pharmaceutical companies are already adapting their existing processes to align with and implement a new global standard for evaluating the environmental impact of pharmaceutical products.
A new overarching guideline on MIDD from the International Council for Harmonisation is expected to harmonize expectations regarding documentation standards and model development, data used in analyses, model assessment, and its applications.
Pharma firms are keen to ensure that artificial intelligence tools used in the earlier stages of drug discovery are excluded from the “onerous scope” of the EU’s AI Act, as this could “defeat” the benefits of using this technology, says Clifford Chance’s Stephen Reese.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Using artificial intelligence in drug discovery and development could have huge benefits for companies, but a key challenge will be addressing how data is used to train AI tools and managing intellectual property issues, says Clifford Chance’s Stephen Reese.
As healthcare shifts rapidly into the home, clinical trials are only beginning the long transition needed to keep up.
Human-centric design, a risk-based approach and lifecycle management are among the ten guiding principles for artificial intelligence (AI) that pharma should follow when using AI in the drug lifecycle, the FDA and EMA say in a joint document.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Preference research is a large and evolving field, says the International Council for Harmonisation.