BioTech Shares Fall in Wake of Gottlieb Resignation
After the former FDA commissioner abruptly announced his resignation last Tuesday, medical technology shares began to trend downwards.
In a comment made to CNBC News, biotech analyst Michael Yee explained: “I think people are a little bit shocked, and taking a step back and saying, ‘what does this mean for those innovative small biotechs?'” In light of Gottlieb’s announcement, the NYSE Arca Biotech Index has fallen by nearly 4 percent. Shares have seemingly re-stabilized since the initial drop, but market analysts note that the market may remain unstable until a commissioner is announced.
NHS Outlines Vision for New Technology Unit
In his keynote address at the Digital Health Technology show in London, U.K. Health Secretary Matt Hancock outlined his vision for the agency’s newest department: NHSX. Hancock explained that NHSX will bridge the health care and technology sectors: allowing the health industry to more rapidly adapt to new technological standards: “I want to bring the culture, the openness, the productivity, the speed of iteration of the internet to the way we deliver tech in health and care.” Hancock noted that these changes will require updated regulatory frameworks, stating: “We’re going to rigorously enforce these standards at the point of purchase, but we’ll prescribe the bare minimum so long as they meet the standards.” Hancock also alluded to “regulatory sandbox” models that would allow for pre-approval trials.
MIT Research Analysis Finds: “It Pays to Have a Digitally Savvy Board”
A new business analysis study led by researchers at the Massachusetts Institute of Technology Sloan School of Management, conducted through the use of machine learning, concluded that companies with digitally competent board members significantly outperform their counterparts. The study, which analyzed over 40,000 company data points, found that “digitally savvy” boards directly correlated with advantages in key metrics such as revenue growth, return on assets, and market cap growth. In light of these findings, the study’s authors noted that “doing business in the digital era entails risks ranging from cybersecurity breaches and privacy issues to business model disruptions and missed competitive opportunities. When a board lacks digital savvy, it can’t get a handle on important elements of strategy and oversight and thus can’t play its critical role of helping guide the company to a successful future.”
FDA Announces New Acting Commissioner
In his opening statements to the House Committee on Energy & Commerce on Tuesday, Health and Human Services Secretary Alex Azar announced Ned Sharpless, MD as the interim replacement for former FDA Commissioner Scott Gottlieb. Sharpless previously served as the director for the National Cancer Institute. Azar assured the committee that the agency would remain committed to previously outlined goals, stating: “There will be no let-up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes.” The search for a permanent commissioner is actively underway.
VA Announces Precision Medicine Testing with Sanford Health
Veteran Affairs Secretary Robert Wilkie announced a new precision medicine testing initiative in a publicly released statement on Monday. Partnering with medical organization Sanford Health, the initiative will provide veterans with complimentary access to genetic testing that can “indicate how their body will respond to certain drugs.” The program’s pilot in Durham, North Carolina will initially extend to cancer survivors, but will eventually expand to up to 250,00 U.S. veterans at 125 locations by 2022. Wilkie remarked: “This testing will help providers at the VA prescribe the most appropriate medications at the right dose.”