More DCAT Value Chain Insights

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

As part of its Drug Competition Action Plan, the US Food and Drug Administration (FDA) has issued draft guidance to outline a new regulatory pathway for “competitive generic therapies” (CGTs) to provide certain incentives for industry to develop...

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...