Features

Several CDMOs/CMOs are proceeding with large-scale investments in new biomanufacturing facilities as biologic drug-substance manufacturing continues to be an active area of investment among CDMOs/CMOs. What companies are expanding production capacity? 

The bio/pharma industry and other stakeholders have provided input on a recent FDA discussion paper on artificial intelligence (AI) in drug manufacturing as the agency considers a regulatory framework and issues to consider when overseeing AI-based drug manufacturing.

What are the blockbusters of the future? A recent industry analysis points to the leading contenders from late-stage or newly approved drugs that are slated to launch in 2023 and that are poised for potential blockbuster status over the next five years. Which drugs are the leading contenders?

The European Commission’s proposal to revise the EU’s pharma legislation includes changes for market exclusivity, further incentives and support for innovation, and measures to increase availability of both innovator and generic drugs. What does the industry think?

Lisa Martin, Senior Vice President, Global Procurement, and Chief Procurement Officer, GSK, discusses the company’s Sustainable Procurement Program for Suppliers and how the company is working with suppliers to meet its sustainability targets. 

The European Commission has issued its long-awaited proposal to reform pharmaceutical legislation in the EU, the first major overhaul in 20 years, which includes new requirements to address drug shortages and secure supply chains. 

Graham Lewis, Vice President, Global Pharma Strategy, IQVIA, gave a bio/pharma market overview at DCAT Week and outlined what lies ahead for the industry. 

PwC’s bi-annual Global Crisis and Resilience Survey reveals companies and business leaders overestimate their resilience despite operating in a period of supply disruption. 

Increased demand in biologic-based drug development is a key factor driving demand for parenteral drug manufacturing, and CDMOs/CMOs are responding with recent investment to expand capacity. DCAT Value Chain Insights rounds up the latest developments among CDMO/CMOs. 

The FDA has issued draft guidance that outlines how drugmakers should notify the agency of a discontinuance or interruption in manufacturing finished products and APIs to reduce the impact of drug shortages. What are others proposing to address the problem?