In-depth analysis of the critical issues impacting the full spectrum of the pharmaceutical manufacturing value chain.
The FDA and the European Medicines Agency (EMA) are expanding their scope of investigation to evaluate other active pharmaceutical ingredients (APIs) that contain nitrosamine impurities, an issue that first surfaced last year with “sartan”-APIs,...
New digital tools hold the potential to transform the pharma customer–supplier relationship, but how? In DCAT Sharp Sourcing LIVE, a livestreamed webinar on Oct. 10, learn how artificial intelligence, the IoT, blockchain technology, and advanced...
Which CDMOs and CMOs are making the mark in terms of deal-making and expansions and what manufacturing sectors are seeing the greatest activity? DCAT Value Chain Insights rounds up the key investments by CDMOs/CMOs making the news.
Key activity in...
Earlier this month, Mylan and Pfizer agreed to combine Mylan with Upjohn, Pfizer’s off-patent branded and generic established medicines business. The deal is expected to close in mid-2020 and will create a new company with pro forma 2020 revenues...
A recent analysis by the US Government Accountability Office shows that only 12% of the 2,030 generic drug applications reviewed by the FDA from fiscal years 2015 through 2017 were approved in the first review cycle. What is the impact for...
With biologics assuming a greater portion of the industry’s pipeline and commercialization strategies, what are key trends and company activity in this sector? To expanding roles of niche modalities in cell and gene therapies to advances in...
The European Medicines Agency (EMA) has issued two guidance documents, respectively to pharmaceutical companies and national regulators in the European Union (EU), to develop and coordinate actions to better prevent, identify, manage, and...
In an industry roundtable, DCAT Value Chain Insights examines the current and future state of the end-to-end business model for CDMOs/CMOs, in which one provider offers development and manufacturing services for both active pharmaceutical...
What does it take to implement an end-to-end-business model, meaning a single CDMO/CMO providing development and manufacturing services for both active pharmaceutical ingredients (APIs) and drug products? DCAT Value Chain Insights gains input from...
The US Food and Drug Administration (FDA) has approved 14 new molecular entities (NMEs) thus far in 2019, behind the pace of last year’s record-setting 59 NME approvals. Which drugs have made the mark thus far and are there potential blockbusters...
