More DCAT Value Chain Insights

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

Orphan drugs represent a niche sector in the global pharmaceutical market, but have accounted for approximately 40% of new drug approvals in the US over the past three years. Traditionally the focus of smaller innovator companies, the...

The pharmaceutical industry is on a record-setting pace for approvals of new molecular entities (NMEs) in 2018. Through early November, the FDA had approved 48 NMEs, already outpacing 2017’s recent high of 46 NME approvals and nearing the high mark...

Drug pricing took center stage once again with a proposal by US Department of Health and Human Services Secretary Alex Azar to require drug companies in the US, for the first time ever, to include in their TV advertising the list price of any drug...

A recent analysis by Deloitte of 400 CEOs and board members from US organizations with $1 billion or more in annual revenues examines executives views on four critical strategic risks, including the extended enterprise involving third-party...

In what market segments are contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) expanding? DCAT Value Chain Insights highlights key activity in drug-substance and drug-product development...

A recent analysis by Ernst & Young (EY) of 2,600 executives shows that although 2018 is on track to become a near-record year for the number of global mergers and acquisitions (M&A), corporate acquisition appetite is at a four-year low. How...

Pfizer announced that Ian Read, current Chairman and CEO of Pfizer will step down as CEO January 1, 2019 to be succeeded as CEO by Albert Bourla, the company’s current chief operating officer. Does the changing of the guard mean a shift in...

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...