In-depth analysis of the critical issues impacting the full spectrum of the pharmaceutical manufacturing value chain.
The UK and the European Union (EU) are resuming negotiations this week (September 29 to October 2, 2020) for a deal that would define the UK’s future relationship with the EU post Brexit. As the clock winds down to reach a deal or not, the pharma...
The rise in the number of orphan-drug approvals and an increase in the development of more targeted therapies with smaller patient populations results in lower-volume drugs. What is the impact on production economics, and how can pharma companies...
Buoyed by $2 billion in funding by the private equity firm, Blackstone, a $1-billion partnering deal with Regeneron Pharmaceuticals, and potential gains from a possible blockbuster anti-cholesterol drug it has licensed to Novartis, Alnylam...
The FDA has issued guidance to advise drug manufacturers how to resume normal manufacturing operations that were impacted by the COVID-19 pandemic, which has caused unusual challenges: employee illness and absenteeism, travel restrictions, site...
Injectable drugs are assuming a larger role in recent drug approvals and drug development owing to the increase in biologic-based drug development and complexity of APIs, which make injectable delivery a preferred option due to molecule size,...
President Donald Trump signed executive orders this week to require the use of most-favored-nation drug pricing in the US for Medicare drugs. What does it mean for the pharma industry?
Inside the latest executive orders on drug pricing
This week...
Solid-dosage products continue to be a mainstay of new drug approvals. How are new drug approvals for solid-dosage products trending? Which CDMOs/CMOs are expanding in solid-dosage development and manufacturing with announcements made thus far in...
Which CDMO/CMOs of small-molecule or biologic-based APIs have announced or are making expansions thus far this year? Has expansion activity been greater in small molecules or biologics? DCAT Value Chain Insights rounds up the latest.
A roundup of...
How a collaborative approach between small and large drug developers with the right CDMO can overcome critical challenges to achieve greater efficiencies in quality, time, and cost – at every stage of the small molecule drug lifecycle.
Small molecules continue to dominate approvals of new molecular entities (NMEs), accounting for approximately three-quarters of NME approvals over the past several years. What have been the small molecules approved as new molecular entities thus...
