Features

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.

Driven by growth in the oncology drug sector, high-potency active pharmaceutical ingredient (HPAPI) manufacturing continues to be an active area of investment by CDMOs/CMOs. Which companies are expanding? DCAT Value Chain Insights rounds up the latest expansions in HPAPI manufacturing. 

The US government has issued updated guidance for its drug-pricing negotiation plan, which for the first time allows the US government to negotiate drug prices under Medicare, It follows opposition from the bio/pharma industry challenging the constitutionality of the plan. 

What is the outlook for the global generic-drug market? A looming biologics patent cliff and double-digit growth for specialty generics bodes well for the market, but what is the outlook for other sectors in the generics market? DCAT Value Chain Insights takes an inside look on what the market may hold. 

The Association for Accessible Medicines (AAM), which represents generic-drug and biosimilar developers and manufacturers, has issued a white paper that outlines recommendations to address shortages of generic drugs and ways to ensure sustainable supply.