Wearables Evolve from Wellness to Clinical Medicine

Wearables – including consumer products like FitBit wristbands and smartwatches – are quickly moving beyond their use as wellness products that track steps and sleep patterns to incorporate serious medical device capabilities and clinical applications.   In September 2018, the… Read »

The Changing World of Medical Marketing

A recent survey published in the Journal of the American Medical Association (JAMA) reported that the medical marketing spend in the United States rose from approximately $17.7 billion in 1997 to just under $30 billion in 2016. The biggest growth… Read »

Nobel Award Winning Science Reaches the Clinic — Finally

In 2006, Japanese scientist Shinya Yamanaka turned back the biological clock of mature mouse cells, reprogramming them into stem cells capable of becoming any cell types. This accomplishment led to his sharing a Nobel Prize in Physiology or Medicine in… Read »

Machine Learning and Drug R&D

We recently wrote about the growing use of machine learning and artificial intelligence (AI) in healthcare. That blog post talked primarily about the expanding applications of AI in clinical diagnostics, based on AI’s superior abilities in pattern recognition. Within the… Read »

Targeting Brain Cancer with New Vaccine Approaches

Glioblastoma multiforme (GBM) is the most common form of brain cancer affecting adults. It is also one of the deadliest and hardest to treat cancers. About half of all people with GBM survive longer than 18 months, but only 15%… Read »

Artificial Intelligence and Image-Based Diagnostic Tools

We have recently been hearing much about “machine learning” and “artificial intelligence” (A.I.). While many tend to use the two terms almost interchangeably, there is a distinct difference between the two.   Machine learning, also known as “deep learning,” is… Read »

One-and-Done Pricing Challenges

As more gene and cell therapies come to market, a big challenge facing both drug developers and payers is designing and instituting appropriate pricing models for these one-time, potentially curative treatments. Innovation should be rewarded, and a curative — or… Read »

Drug Pricing: A Key Political Issue for 2019?

Drug pricing is clearly going to be one of the major topics of discussion — and a key political issue — in 2019. Drug makers began the New Year with price increases in the United States on more than 250… Read »

FDA and Direct-to-Consumer Genetics Testing

When 23andMe launched its first genetic test to the consumer market in 2013, the U.S. Food and Drug Administration (FDA) quickly ordered the company to stop marketing the test without necessary approvals as a medical device, citing the potential for… Read »

Dsuvia — Much Needed Analgesic or Potential New Contributor to the Opioid Crisis?

Does the United States really need another opioid drug, given the enormous public health crisis of opioid addiction facing the country today? Many experts are asking this question about the FDA’s approval in November of Dsuvia (sufentinil), a powerful opioid … Read »

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