Month: April 2018

30
Apr 2018

Bionest

Update on FDA’s Patient Benefit-Risk Assessment Program

Over the past several years, the U.S. Food and Drug Administration has begun efforts to further incorporate patient perspective on benefits and risks of potential new treatments in their regulatory reviews and to bring additional transparency and communication to the deliberation that goes into regulatory decisions. The agency has been responding to an increased awareness...
24
Apr 2018

Bionest

FDA Decision on Dexcom Device Changes Playing Field for Continuous Glucose Monitoring

At the end of March, the U.S. Food and Drug Administration approved a new continuous glucose monitor (CGM) system, the Dexcom G6. The new sensor is smaller than current CGM devices, about the size of a quarter. It comes already calibrated from the factory, thus freeing users from daily finger sticks. It is formatted as...
17
Apr 2018

Bionest

Moving from Exploratory Collaborations to Record-Setting Deals in IO

In early March, we wrote about the collaboration between Bristol-Myers Squibb and Nektar aimed at developing Nektar’s T-cell stimulating molecule NKTR-214 in combination with BMS’s checkpoint inhibitor Opdivo (nivolumab). That deal brought Nektar an eye-opening $1.85 billion in upfront cash and investments for a share of its development-stage drug, with the potential for an additional...
11
Apr 2018

Bionest

Apps and Drugs/ Apps as Drugs

In our January post on what we planned to watch for in 2018, we predicted that digital health would come to the foreground of activity this year. And indeed, we are starting to see a lot of buzz around digital health. In March, Novartis and Pear Therapeutics announced the first development deal between a major...
3
Apr 2018

Bionest

The Rise of AI in Drug Discovery and Development

“Deep learning” is an advanced machine learning technology that enables the generation of relevant insights from enormous amounts of data. Computers are able to identify complex patterns in data from many disparate sources and generate algorithms to explain them. This allows a computer to simultaneously create and test original hypotheses with much greater speed and...