A Look Ahead: Bio/Pharma’s Top Policy Issues in US Elections Aftermath
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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?

A Strong Contract ADC Market Drives Expansions in High-Potency Manufacturing
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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.

Making the Innovation Cut: New Drug Approvals Thus Far in 2024
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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?

Mark Your Calendar: Mitigating Supplier Risk for Steady-State Operations
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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.

Tracking Innovation in RNA Manufacturing
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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.

What’s in Store for the Global Economy
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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?

A Look Ahead in the CDMO Drug Product Sector
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Novo Holdings’ pending $16.5-billion acquisition of Catalent to acquire sterile manufacturing capacity to support its Type 2 and obesity drugs is a major move in the CDMO drug-product space, What are other key developments.

The CDMO/CMOs Report: The Marriage of Small Molecules & Biologics
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Biologics, including cell & gene therapies, has been an active area of investment for pure-play biologics CDMOs, but it also has been a target for several CDMOs/CMOs of small-molecule APIs to position themselves or increase their offerings in the biologics space. A roundup of recent developments.

Drug Pricing Front & Center Again in the US: Impact on Manufacturers
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With less than a month before the Presidential and Congressional elections in the US, drug pricing is again front and center on the country’s policy agenda. As different approaches to reduce prescription drug prices emerge, what would be the impact on drug manufacturers?

Navigating the Supply-Chain Impacts of US Port Closings
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The shutdown of ports on the US Gulf and East Coasts this week due to a labor strike had the potential for a major impact on the flow of US chemical shipments. With a strike now temporarily diverted, how would have chemical and pharma ingredient supply chains been affected?