Features

A recent analysis by the management-consulting firm KPMG shows that inflation and supply-chain fears are easing, but that the global economy continues to face uncertainty. Lessening supply-chain pressures and resilient labor markets are supporting economic recovery, but uncertainty remains high. What are the prospects for global GDP growth and inflation for the balance of 2023?

The UN Global Compact, which represents more than 18,000 companies globally and reflects CEOs commitments, has issued a new guidance on sustainable supply chains to help companies better manage climate risks by placing the concept of a Just Transition at the center of transition planning and risk-management strategies.

Members of Congress are calling for action to prevent drug shortages in light of upcoming issues facing pharmaceutical manufacturers, distributors, and dispensers as they work to bring the drug supply chain into compliance with requirements under the Drug Supply Chain Security Act (DSCSA). Beginning November 27, 2023, all drugs in the US must be able to be tracked electronically on the unit level, and drugs not complying cannot be distributed or dispensed.

What have been some of the highs and lows thus far in 2023 from the large bio/pharmaceutical companies and what may be expected for the rest of the year? From Pfizer’s revenue declines for its COVID-19 products, to rising sales from Lilly and Novo Nordisk for their diabetes and weight-management drugs, to Viatris’ plan for further divestures, DCAT Value Chain Insights sums up the latest developments.

What are the top 10 drug-development deals (mergers and acquisitions) between the large bio/pharmaceutical companies and smaller companies thus far in 2023? Which smaller companies have been the targets of large companies and in what product areas?

The House Energy and Commerce Committee has issued a discussion draft with policy proposals to address drug shortages in the US. What is in the proposal?

The European Medicines Agency has published a draft reflection paper and is seeking input from the bio/pharma industry and other stakeholders on the use of artificial intelligence in drug development and the product lifecycle, including manufacturing. The agency plans to hold a workshop on AI in late November and is seeking input by the end of the year.

Injectable drugs are an increasingly important part of the bio/pharma market with the rise in biologics as well as greater interest for delivery of injectables through self-care methods. What are key trends and technological developments for injectable drugs, including drug-device technology? DCAT Value Chain Insights looks at the latest.

In what could have a chilling effect on deal-making in the bio/pharma industry, the US Federal Trade Commission and the US Department of Justice issued draft guidelines outlining their review of mergers and acquisitions to determine compliance with federal antitrust laws. Will the mega-deal become a deal of the past?

The bio/pharma industry is urging FDA to postpone its October 2023 deadline for testing for novel nitrosamine impurities in drugs. The industry provided the feedback in response to FDA’s call for input on how it should regulate these impurities.