More DCAT Value Chain Insights

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

At a Congressional hearing last week, executives from AbbVie, AstraZeneca, Bristol-Myers Squibb, Johnson & Johnson, Merck & Co., and Pfizer examined drug pricing as part of a larger policy debate on ways to lower prescription drug costs,...

When a global pharmaceutical company’s pediatric formulation and dosage form(s) didn’t fit the plant equipment profile used to manufacture the adult dosage form at the customer’s facility, they needed a high quality, agile CDMO with...

As part of its Drug Competition Action Plan, the US Food and Drug Administration (FDA) has issued draft guidance to outline a new regulatory pathway for “competitive generic therapies” (CGTs) to provide certain incentives for industry to develop...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