In-depth analysis of the critical issues impacting the full spectrum of the pharmaceutical manufacturing value chain.
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...
What have been the key deals among pharmaceutical companies thus far in 2019? From pending mega mergers of Bristol-Myers Squibb and Celgene and AbbVie and Allergan to Gilead’s large-scale R&D pact with Galapagos, DCAT Value Chain Insights...
The escalating trade tensions between the US and China took another turn as the American Chemistry Council, which represents US manufacturers of chemicals and plastics, testified last week to oppose what it called a “stunning and confusing”...
Whether on the “buy” or “sell” side, using the right negotiation tools and strategies is crucial. In DCAT Sharp Sourcing LIVE, a webinar from DCAT livestreamed from London, Niro Sivanathan, PhD, Associate Professor, London Business School, shares...
The pharma industry is providing feedback on the FDA’s draft guidance on continuous manufacturing, with GSK, Eli Lilly, AstraZeneca, J&J, the Association for Accessible Medicines, CEFIC’s Active Pharmaceutical Ingredients Committee, and...
Albert Bourla, who became CEO of Pfizer in January, has made his first large-scale deal as CEO: a pending $11.4-billion acquisition of Array BioPharma, which specializes in small-molecule cancer drugs. How does the move fit into the company’s...
