The FDA has issued draft guidance to lay out its current thinking on remote regulatory assessments, an approach it took when onsite inspections were not possible due to the COVID-19 pandemic. What’s in the plan?
Emerging Pharma companies are important as drug-development partners with larger bio/pharma companies and represent an important customer base for CDMOs/CMOs. Which companies and their deals have stood out this far in 2022?
Mid-Year Review: New Drug Approvals Thus Far in 2022
As we move past the mid-way mark in 2022, how has the industry fared with new drug approvals? Is the industry keeping pace with prior years’ innovation levels? What do the numbers show, including the mix between small molecules and biologics?
The European Union agreed this week to reduce natural gas demand by 15%, starting August 1 and lasting through next March, to prepare for possible disruptions of gas supplies from Russia. The EU chemical and pharma industries weigh in.
What’s Next for the New GSK After Consumer Healthcare Spin-off?
GlaxoSmithKline has completed the spin-off of its consumer healthcare business to form a separate stand-alone $11-billion company, Haleon. The move is part of a larger strategic plan by GSK’s CEO Emma Walmsley to drive growth in its core bio/pharmaceuticals business. What is next for the New GSK?
Supplier Relationship Management: Examining the Talent of the Future
How are the skillsets for sourcing, procurement, and supply management professionals evolving to meet future talent needs, including digital capabilities? What will be needed for effective supplier relationship management in the future both from pharma companies and suppliers?
What have been some key recent investments in manufacturing by the large bio/pharmaceutical companies? What areas, small-molecule APIs, biologics, or drug products, have been attracting the investment dollars? DCAT Value Chain Insights rounds up key projects.
A recent US government report evaluated the FDA’s process for for-cause inspections of foreign drug-manufacturing facilities. Although the FDA has made changes to improve the process, Congress and others have raised concerns. What did the review show?