More DCAT Value Chain Insights

In-depth analysis of the critical issues impacting the full spectrum of the pharmaceutical manufacturing value chain.

Lengthy early-development timelines are common across new and emerging biotech companies for a multitude of reasons. Striking the right balance of speed, quality, risk, and investment allows you to shorten timelines and work with efficiency....

By 2025, $112 billion of biologic medicines will lose exclusivity in the global market. Uptake of biosimilars will gain momentum, especially in the US, which has historically lagged compared to Europe. Which companies and biologics face biosimilar...

The bio/pharma industry is moving to meet a November 2023 deadline, under the Drug Supply Chain Security Act (DSCSA), which requires manufacturers to set up electronic systems to track their products through the supply chain. An industry...

A joint industry group of innovator and generic-drug makers and consumer healthcare companies met with the FDA to go over the challenges the industry is facing in implementing a FDA guidance for risk assessments of all chemically synthesized APIs...

What have been the key deals thus far in 2021 by CDMOs/CMOs? Biomanufacturing, including for cell- and gene-therapies, continues to be an active target for mergers and acquisitions. The largest deal thus far is Thermo Fisher’s pending $20.9-billion...

Pharmaceutical and biopharmaceutical companies have been extensively using contract research organizations (CROs) to meet their challenging needs in R&D and standard work for several decades. A noticeable shift occurred in outsourcing research...