Features

Although a niche area, market interest in radiopharmaceuticals is on the rise as certain bio/pharma majors and smaller companies strike drug-development deals and CDMOs/CMOs specializing in this area expand production capacity. 

This week marks the second anniversary of the launch of the EU’s “Rare Disease Moonshot,” a commitment by nine European associations to break down barriers to advance development of therapeutics…

Which bio/pharma companies and CEOs may be under the industry’s radar but are executing better-than expected performance and winning strategies for their companies? What products—development and commercial—are delivering? DCAT Value Chain Insights takes an inside look.

FDA conducted 621 foreign and 444 domestic inspections in fiscal year 2023, which was up from pandemic levels when in-person inspections were paused, but 36% fewer than pre-pandemic levels. A shortage of inspectors is a major factor. What’s the impact on Pharma?

Following the US Presidential election this week, two industry groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO), issued statements broadly highlighting key policy issues of interest. What’s on the agenda?

Driven by strong demand in the oncology drug market, high-potency manufacturing continues to be an active area of investment for CDMOs/CMOs for both drug substances and drug products. Growth in the contract market for antibody drug conjugates, one component, is projected in the double-digits.

How is product innovation faring in the bio/pharma industry thus far in 2024? Through the end of October, FDA’s Center for Drug Evaluation and Research has approved 38 new drugs. Which companies  and products have made the cut, and which may be best poised for market success?

Continual monitoring and evaluation of risk once working with suppliers is critical. An upcoming DCAT webinar will provide a customer–supplier view of the key performance indicators. key risk indicators, challenges, and scenarios to take into consideration to mitigate risk.

The success of mRNA-based COVID-19 vaccines has generated interest in RNA-based drug development, with over 200 RNA drugs estimated to be in development. The promise of RNA medicines in turn has engendered innovation in manufacturing these drugs, including from start-up companies.

With the rate of inflation continuing to moderate, some economists are projecting a soft landing is in place and that overall economic growth is expected to be steady, but some headwinds still remain. What can be expected for the remainder of this year and in the near term?