Pharma is fast becoming Donald Trump’s favorite whipping boy. Last month, Trump vowed to bring down drug prices. Early in January 2017, he slammed the industry for “getting away with murder.” And on 14 JAN 2017, he promised the Washington Post he’d subjugate drug makers with the power of the Tweet.
In the same week that Donald Trump met with Silicon Valley leaders to interview for the top job at the FDA, he has also met with an eclectic mix of candidates for his pick as National Institutes of Health (NIH) chief.
The belief that the FDA is to undergo a major shift in thinking was given further credence as another curveball was thrown into the mix. Balaji Srinivasan, CEO of Bitcoin startup 21.co, is now being considered for the Agency’s top job.
Remember the Trump euphoria that hit BioPharma stocks after the president-elect captured the Electoral College in November? Well, scratch that.
If a decline in US Food and Drug Administration (FDA) approvals of new pharmaceuticals is a bad sign for the industry, then 2016 was the worst year since 2010.
Georgetown University’s Institute for Reproductive Health (IRH) is recruiting up to 1,200 women for a real-time study of Cycle Technologies’ smartphone app that calculates a woman’s fertility on a daily basis.
A shorter course of radiotherapy with fewer sessions and higher dosage is as effective as the standard of care in treating prostate cancer, a U.K. study found. Switching over to this shorter schedule would not only benefit patients, but also help the National Health Service save tens of millions of pounds.
As our world becomes more interconnected, so do our medical devices: we are connecting devices such as insulin pumps and glucose meters to apps, some of which also have cloud connectivity, enabling patients to share their health data with caregivers and loved ones. However, this increased interconnectivity comes with vulnerability to cybersecurity threats.
Researchers at Beth Israel Deaconess Medical Center and Harvard Medical School have worked together to create an analysis of breast cancer pathology that incorporates artificial intelligence. They found that their system–and the evaluation by pathologists themselves–worked better when used in conjunction than either did alone.
ISSUE: FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces. BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data.