In-depth analysis of the critical issues impacting the full spectrum of the pharmaceutical manufacturing value chain.
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 address impacts of the novel coronavirus (COVID-19) on clinical...
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 increase domestic production of key...
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 incentivize domestic drug manufacturing in the US. What...
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 FDA seeking to incentivize their market entry?
FDA’s Drug...
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 the EU as well as a basis for a free-trade...
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 coronavirus outbreak. What does...
Stephan Haitz, President, CDMO Sales & Marketing discusses small molecule trends and how the CDMO industry is constantly evolving to meet the demands and needs of the growing clinical pipeline.
Drug pricing is a major policy issue in the US with both Congress and the Trump Administration offering proposals for reform, but state governments are also moving forward with their own plans. What are the latest developments?
Federal proposals...
A recent analysis from Clarivate Analytics’ Cortellis identifies 11 drugs that are expected to enter the market in 2020 and achieve blockbuster status by 2024. Which drugs are making the mark?
Blockbuster watch: Big Pharma
A recent analysis by...
Dr. David Pearson, Chief Scientific Officer of Cambrex Edinburgh, discusses how a full understanding of the crystalline landscape of an active pharmaceutical ingredient (API) molecule can predict stability and solubility, minimizing...
