Blogs

FDA Chief Affirms Support for Effectiveness in Approving Drugs The Food and Drug Administration (FDA) will not yank its requirement that drugs and devices must show they work before they can be sold on the market, the agency's commissioner said on Oct. 24. The confirmation by FDA Commissioner Scott Gottlieb came in response to a question at a health summit and followed several of his speeches indicating the agency will rely more heavily on postmarket data. After President Donald Trump assumed office, there was speculation he would appoint a commissioner like investor Jim O'Neill, who has called for eliminating the effectiveness requirement and only demonstrating ...

Connecting online holds myriad professional opportunities. By Sean Ekins, Ph.D., D.Sc. Imagine you are the only scientist with a specific expertise. It would be a pretty lonely existence perhaps, until someone needed you. But there is no guarantee anyone will ever contact you! Perhaps this is close to what it was like as a scientist in the early 20th century, no distractions, and you could focus all your time on your research. Communication was slow, travel was limited, and your only interaction with other scientists from outside your own institution would be at the few learned societies. Collaboration, if it happened, would likely be exceedingly rare. ...

Bringing Precision Medicine to Antibiotics Disease-specific antibodies are showing promise for treating bacterial infections, a pharmaceutical researcher said during a recent AAPS webinar. By David Pittman The antibiotics field needs a paradigm shift and to embrace a “precision medicine” mindset in the development of new therapies. Traditional small-molecule drugs are increasingly ineffective against bacterial infections, creating a demand for alternatives, a recent American Association of Pharmaceutical Scientists webinar noted. Pathogen-specific antibiotics do not have the issues of resistance that today’s broad-spectrum antibiotics carry, ...

The brain retains a nearly impenetrable wall against any potential central nervous system (CNS) therapeutic agents attempting to invade its fortress. Due to the complexity of the brain, developing CNS therapeutic drugs remains a formidable challenge for all pharmaceutical companies. In 2014, the Tufts Center for the Study of Drug Development reported that drugs developed between 1999 and 2013 that were designed to target CNS diseases took more than one year longer (12.8 months, 18 percent longer) to develop than non-CNS drugs. This analysis included 42 CNS and 345 non-CNS therapeutic compounds approved by the Food and Drug Administration (FDA). Additionally, ...