2023 Drug Development Pharmaceutical Manufacturing 
European Pharmaceutical Review
JANUARY 9, 2024
Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Figure 1 : adapted from Saha, G. Tuijin Jishu/Journal of Propulsion Technology, 44(3), 1384-1392.
Drug Patent Watch
DECEMBER 30, 2024
The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. New Drug Application (NDA) : Needed for marketing approval of new drugs. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs.
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Drug Patent Watch
DECEMBER 10, 2024
They can help ensure that these submissions are complete, accurate, and timely, which is critical for advancing drug development programs. They can help ensure that the commercial pharmaceutical manufacturing process is designed to meet regulatory requirements and offer insight into the most effective manufacturing strategies.
European Pharmaceutical Review
MAY 11, 2023
The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. The paper also highlighted that AI/ML can enhance manufacturing supply chain. Comment on the discussion paper here.
Express Pharma
APRIL 8, 2025
To address growing demand from the pharmaceutical industry, Asahi Kasei has launched a new division, Asahi Kasei Life Science, effective from 1 April 2025. The new structure is designed to unify its bioprocess businesses and streamline services offered to pharmaceutical partners across drug development and manufacturing.
European Pharmaceutical Review
JANUARY 24, 2024
The first in our inaugural Pharma Horizons report series is dedicated to exploring the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control.
FDA Law Blog: Biosimilars
JUNE 27, 2023
Valentine Named Top Lawyer Under 40; Only Food and Drug Lawyer Selected Hyman, Phelps & McNamara, P.C. (HP&M) Valentine , as a 2023 Rising Star. James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list. HP&M’s Kurt R. Dormer Jeffrey N. Gibbs Paul M. Hyman Alan M.
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