DCAT reports that FDA has selected seven companies for its new PreCheck Pilot Program, designed to encourage US-based drug manufacturing through earlier engagement and a more predictable regulatory path.
Driven by increased demand in biologic-based drugs, biologic drug substance manufacturing continues to be an active area of investment by contract development and manufacturing organizations/contract manufacturing organizations (CDMOs/CMOs), including several multi-billion large-scale biomanufacturing projects. What companies are expanding, and where do these expansions stand?
The European Commission proposed last month an emergency intervention in Europe’s energy markets to address recent dramatic price rises as the EU faces the effects of a severe mismatch between energy demand and supply. What is in the proposal?
Biomanufacturing for both traditional biologics and new modalities, such as cell and gene therapies, continues to be an active area of investment for CDMOs/CMOS. Some of the major investments by the larger CMDOs/CMOs are outlined in this article.
Sean Diver, president of DCAT speaks about the pharmaceutical industry’s role during the Covid-19 pandemic, trends in drug manufacturing, and key issues for the EU pharmaceutical industry.
DCAT Value Chain Insights rounds up recent expansion activity for highly potent drug substances and drug products.
