Smartlab Europe

Drug Research

Enhertu Priority Review in HER2-Positive Early Breast Cancer

The supplemental Biologics License Application - sBLA for Enhertu - trastuzumab deruxtecan by AstraZeneca and Daiichi Sankyo has been accepted as well as granted Priority Review in the U.S. when it comes to the treatment of adult patients with...

Lilly Launches New AI Supercomputer for Drug Development

Eli Lilly has launched what it describes as the most powerful AI factory wholly owned and operated by a pharmaceutical company, marking a significant expansion of advanced computing infrastructure in life sciences. The system, named LillyPod, was inaugurated in...

Contamination Control with Toxicological Reference Data

Centralizing expert-verified toxicological datasets is now a critical requirement for modern pharmaceutical facilities operating under stringent global regulations. By transitioning from generic cleaning limits to precise Health-Based Exposure Limits derived from high-quality platforms, manufacturers ensure that cleaning validation protocols are scientifically sound and audit-ready. This approach integrates rigorous toxicological risk assessment into the broader contamination control strategy, safeguarding patient health while optimizing multi-product manufacturing efficiency and regulatory compliance.

AstraZeneca Breztri Reports Positive Phase III Trial Results

Results from the Phase III KALOS and LOGOS trials evaluating AstraZeneca Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) in patients with uncontrolled asthma have been published in The Lancet Respiratory Medicine, reporting statistically significant and clinically meaningful improvements compared...

Sustainable Chemical Processes in Drug Manufacturing

Implementing green chemistry principles and sustainable chemical engineering in drug production is essential for reducing environmental impact and improving resource efficiency.

Novartis Breaks Ground on San Diego Biomedical R&D Site

Novartis has started work on a $1.1 billion biomedical research facility in California, adding a major new pillar to its long-term US investment strategy. The San Diego biomedical R&D site is part of a wider $23 billion expansion programme...

Excipients Innovation Transforming Drug Delivery Performance

Analysis of the evolving role of functional excipients in modern pharmacology, moving beyond inert fillers to become active participants in drug stability and targeted release.

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