More DCAT Value Chain Insights

In-depth analysis of the critical issues impacting the full spectrum of the pharmaceutical manufacturing value chain.

In 2017, the FDA approved the most generic-drug applications ever, 1,027 abbreviated new drug applications (ANDAs), breaking the previous record high set in 2016 by 214 approvals when the FDA approved 813 ANDAs. So how are generic-drug approvals...

Data integrity is fundamental to ensure compliance with current good manufacturing practices (cGMP) and other GXP standards. Regulatory agencies and industry trade groups have released guidance documents to raise standards and compliance. DCAT...

What has been the impact on business strategy as a result of US corporate tax reform, which was signed into law in December 2017? A recent PwC survey of US C-suite executives highlights the investments and business directions taken or planned thus...

What are the key developments in pharmaceutical manufacturing? From large-scale biomanufacturing projects, to advances in cell and gene therapy production, and continuous manufacturing, DCAT Value Chain Insights looks at significant investments...

UK Prime Minister Theresa May faces external and internal hurdles and the possibility of a “no deal,” meaning the UK would leave the European Union (EU) without a Brexit agreement. What is the impact for pharmaceutical companies in terms of...

Oncology is the largest therapeutic sector in the global and US pharmaceutical markets with US spending on cancer drugs reaching almost $50 billion in 2017. Following that trend, CMDOs and CMOs are investing in high-potency development and...

Novartis’ Sandoz, Teva, Perrigo and Mylan are among the companies reporting lower revenues in their generics businesses, principally due to performance in the US market. With these companies revamping their strategies to address changing market...

Emerging pharma companies are an important source of product innovation for the pharmaceutical industry, so which companies are making the mark? DCAT Value Chain Insights takes an inside look. For new molecular entities approved by the US Food and...

The Pharmaceutical Research and Manufacturers of America (PhRMA) has released a new policy position that delinks supply-chain payments as a means to improve patient affordability. The policy is in response to an earlier blueprint issued by the US...