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Sharfstein’s departure: Did he cut and run? (Morning read)

Among today’s current medical news: Interpreting FDA Deputy Commissioner Joshua Sharfstein’s departure, more foes of 510(k) changes, defibrillators that no one needs, new reports on physician burnout, and fresh investment for Alzheimer’s, pre-term birth and emphysema companies.

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Strategy behind Sharfstein. InVivo blog on FDA Deputy Commissioner Joshua Sharfstein’s departure: “Sharfstein’s departure means first and foremost as a change in positioning for FDA facing the incoming Republican majority in the House.”

Medical Marketing and Media: “Former FDA associate commissioner Peter Pitts said the resignation of Sharfstein, whom Republicans view as an overzealous regulator hostile to industry, will make life easier for FDA ahead of contentious PDUFA reauthorization hearings.”

NPR: Sharfstein’s departure will make things like winning funding for the newly signed food safety bill that much harder.

510(k) scrutiny. New Senators have written about proposed 510(k) changes that “have the potential to disrupt the current regulatory balance under the 510(k) pathway, jeopardizing patients’ timely access to new treatments and cures.”

Useless defibrillators. 20 percent of defibrillators are implanted into people who don’t need them.

Physician burnout. One survey found physicians, and particularly residents, were at a higher risk of burnout than nurses and other staff. Another report found half of anesthesiologists met the criteria for “high burnout” or “moderately-high burnout.”

Dialysis tracker. A new Dialysis Facility Tracker, which uses federal data, shows how often patients treated at a facility have been hospitalized, report certain infections or are put on a transplant list.

Dealflow and more. Pre-term birth testing company Sera Prognostics raises $1.4 million; Alzheimer’s biotech Satori Pharmaceuticals has raised $7 million; anti-inflammatory drugmaker Xoma will get $505 million in a drug development deal; RNA therapy company Santaris Pharma received $14 million from Pfizer; drug development business CPEX Pharmaceuticals has been sold for $76 million; and emphysema medical device company PneumRx raised $33 million.

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