Pharmaceutical Industry News Roundup: November 2019

by Staff Writer

Each month, MMS shares key stories on the evolution of the pharmaceutical industry. Here is a selection from last month:

A bold prediction: Machine learning will yield new drug candidates within three yearsSTAT News

At the recent STAT Summit, panelists in the field of machine learning agreed that drug candidates will be discovered by artificial intelligence in the near future. This advancement may change the way pharmaceutical companies handle research.

Casey Ross has the full story

Regulatory science to 2025 European Medicines Agency

The European Medicines Agency (EMA) recently drafted a strategy to advance the agency’s engagement with regulatory science to 2025. The strategy aims to create an adaptive regulatory system for both human and veterinary medicines.

See the EMA website for the full outlook

WHO drafts guideline on data integrity for pharmaceuticals – Regulatory Focus

The World Health Organization (WHO) recently drafted new guidance concerning data integrity within the context of pharmaceutical production and control. Comments on the guidance are welcome until January 15, 2020.

Read Zachary Brennan’s coverage here

ICH overhauls 22-year-old clinical studies guideline – CenterWatch

The International Council on Harmonization (ICH) is changing the guidance ICH E8—General Considerations for Clinical Studies. The new rewrite of the 1997 guideline is expected to take effect in 2020.

Learn more from Leslie Ramsey and Colin Stoecker

Statement on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar productU.S. Food & Drug Administration (FDA)

Since an abbreviated approval pathway was created for biosimilars in 2010, 74 programs for 38 reference products have been enrolled. Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, says that “The promise of biosimilar and interchangeable biological products in providing increased access to important therapies is great, and the FDA will continue to do all that we can to facilitate competition in this area.”

Visit the FDA newsroom for the latest

MMS Holdings doubles growth in South Africa region BioSpace

MMS Holdings announced that its regional operations in South Africa has more than doubled in the past fiscal year, through the addition of new colleagues in Bloemfontein and the successful procurement of key contracts with clinical trial sponsors and research groups. South Africa has been an area of focused growth for MMS due to its well-qualified workforce, strong infrastructure, along with data processing and quality focus.

Read the news on BioSpace

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