This article presents a detailed summary of the drug GMP warning letters issued in FY2017, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements.
The genome editing market is estimated to reach $3.5 billion in 2019 — an increase from $2 billion in 2014 — with a CAGR of 13 to 14 percent. The factors driving this market include increased R&D funding for genomic research, a growing demand for synthetic genes, new technologies in genome editing, and high utilization in plant breeding. However, high regulatory stringencies, lengthy approval processes, and ethical issues associated with the fear of genetic research hamper market growth. This article examines the utilization of genome editing tools and technology and their impact across the drug discovery industry.
Regulators in China have long been concerned that this multitiered network inflates drug prices. A 2017 pilot program, known as the “two-invoices” system, aims to address this issue by changing the way manufacturers, distributors, and healthcare facilities operate in the procurement process.
It seems blockchain technology is following the hype path the cloud did a few years ago. The most talked-about example of blockchain is Bitcoin, a digital currency that does not rely on a central authority (such as the Federal Reserve) to clear financial transactions. A few short months ago, the word “blockchain” was seldom mentioned in supply chain circles. Now, it’s not uncommon to be asked what your blockchain strategy is within those same circles. What has changed is its successful use and blockchain platforms adding functionality.
In the last decade, the healthcare industry has witnessed significant changes, some of which present important challenges to how pharmaceutical companies develop drugs. One such challenge is the shift in influence from the physician to the payer in the adoption of new interventions. This article discusses threats to the traditional model of drug development posed by the increasing influence of payers and considers ways for industry to embrace “value-focused development” to simultaneously adapt to the evolving market and de-risk drug development.