European Union (EU) authorities have issued guidance to pharmaceutical companies and suppliers to provide regulatory flexibility when sourcing reagents, starting materials, intermediates, and APIs for medicines deemed crucial in treating…
Company Executives Outline Growth Strategies and Expansions at the DCAT Member Company Announcement Forum
In this special issue of DCAT Value Chain Insights, we are providing information that would have been presented at the DCAT Member Company Announcement Forum at DCAT Week ’20. Originally…
In the wake of COVID-19, industry groups, including the Pharmaceutical Research and Manufacturers of America and the Association of Accessible Medicines, are raising concerns over reduced availability of international air…
The Race for a Vaccine Against the Novel Coronavirus
Johnson & Johnson reported this week that it expects its lead vaccine candidate against the novel coronavirus (COVID-19) to enter clinical trials in September and outlined a manufacturing plan. Sanofi,…
With a cost of $2.6 billion to bring a new drug to market, a slowing of drug-development activities can have a significant cost to both pharmaceutical companies and CDMOs/CMOs. To…
Indian Government Looks To Increase Domestic API Mfg
In response to the novel coronavirus and India’s reliance on active pharmaceutical ingredient (API) production outside of the country, the Indian government has put forth a $1.3-billion multi-year plan to…
In the wake of the coronavirus outbreak, there is increased evaluation of global drug supply chains. Some members of Congress and the federal government are calling for ways to further…
FDA Issues Guidance for Competitive Generic Therapies
As part of its Drug Competition Action Plan, the FDA has finalized guidance to outline a new regulatory pathway for “competitive generic therapies” (CGTs). What are CGTs, and how is…
The UK and the Pharma Industry in a Post-Brexit World
The Association of the British Pharmaceutical Industry, which represents innovator pharma companies in the UK, has put forth its priorities in the UK’s upcoming negotiations on its future relationship with…
EU Moves To Mitigate Potential Disruptions in Drug Supply
The European Medicines Agency, the European Commission, and EU national regulatory authorities have formed an EU Executive Steering Group to address potential supply disruptions in medicines stemming from the novel…
