More DCAT Value Chain Insights

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

The policy debate on drug pricing is heating up as the US Senate is scheduled to hold hearings with pharmaceutical industry CEOs later this month. Meanwhile, the Trump Administration has stressed its interest for more drug-pricing transparency and...

The formation of the FDA’s Drug Shortage Task Force last year has engendered recommendations by industry stakeholders to mitigate drug shortages, including proposals for production-transparency requirements, incentives for manufacturers, and a...

Cambrex’s Dr. Shawn Conway, Director of Engineering, R&D, outlines how continuous flow processes simplify and break through traditional method limitations to achieve efficiencies in cost, quality and safety. Discussion includes how current...

Small molecules accounted for 42, or 71%, of the 59 new molecule entities (NMEs) approved by the FDA in 2018, continuing a recent trend in which small molecules have accounted for roughly three-quarters of NME approvals. Which small-molecules and...

Innovator and generic-drug companies are squaring off as European Union (EU) authorities draw closer to adopting an export manufacturing waiver for supplementary protection certificates (SPCs). Biosimilar/generic-drug companies and manufacturers of...

The results of PwC’s 22nd annual survey of 1,300-plus CEOs, which were launched this week at the World Economic Forum Annual Meeting in Davos, Switzerland, shows that nearly 30% believe that global economic growth will decline in the next 12...

Last year (2018) was a record-setting year for approvals of new molecular entities (NMEs) by the FDA with 59 NMEs approved. DCAT Value Chain Insights examines the 2018 NME approvals, the product mix between small molecules and biologics, and which...