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May 14, 2020___

Today's Rundown

Featured Story

Novartis CEO: COVID-19 vaccine might take until end of 2021 to reach patients

With all eyes on the prize for a COVID-19 vaccine, researchers are setting aggressive timetables that might be too good to be true. Despite hopes that a shot could be available this year, Novartis' CEO is pumping the brakes—and given his past vaccines experience, he should know. 

Top Stories

HHS whistleblower Bright cites safety risks in questioning coronavirus vaccine timeline

Amid widespread speculation on COVID-19 vaccine timelines, former BARDA chief turned whistleblower Rick Bright said he's skeptical vaccines can be made available in 12 to 18 months. That would require R&D to go “perfectly” from the very start, and “we’ve never seen everything go perfectly," he said.

Trump administration aims to replenish Strategic National Stockpile to brace for 2nd COVID-19 wave

The Trump administration is making moves to replenish the Strategic National Stockpile to get ready for a potential second surge of COVID-19 and will add new supplies like critical care drugs

NYU study flags false negatives from Abbott's portable coronavirus test

A new study measuring the performance of Abbott’s rapid, point-of-care coronavirus test found the device could miss nearly half of positive cases, depending on how the samples were handled and fed into the machine. Conducted by researchers at NYU Langone Health, the study was pre-published on bioRxiv, and has not yet been peer-reviewed.

Biopharma roundup: Oxford shot passes early study; FDA aims to restart inspections

A new study from New York University found that Abbott's point-of-care coronavirus diagnostic could miss nearly half of positive COVID-19 cases. Meanwhile, the FDA is working on a plan to jumpstart on-site drug manufacturing facilities after placing a moratorium on such reviews in early March. 

Healthcare roundup: Cigna offering real-time digital tools for COVID patients

FierceHealthcare's ongoing coverage of how the coronavirus is impacting the healthcare industry.

BMJ, Nature warn against 'sabotaging' COVID-19 response with poor and 'chaotic' trials

The BMJ warns that a “deluge of poor quality research [in COVID-19] is sabotaging an effective evidence-based response,” while Nature argues that more patients are needed for better trial results.

COVID-19 lessons from Humana's work to improve employee well-being

Humana has put a focus on its employee well-being initiatives for years—and that work is offering lessons for responding to COVID-19, executives said. 

French president Macron seeks meeting after Sanofi CEO's vaccine comments

That was fast. Less than a day after Sanofi CEO Paul Hudson said the U.S. would be set for first dibs on the company’s potential COVID-19 vaccine, pushback is mounting, and French President Emmanuel Macron wants a meeting. 

Banner Health revamping doctors' offices in the wake of COVID-19 with virtual waiting room

In the wake of COVID-19, healthcare providers will need to rethink the traditional waiting room experience. Phoenix-based Banner Health is taking that step with the launch of a virtual waiting room across its Banner Medical Group practices. 

Former GSK vaccine head Slaoui to lead federal 'Warp Speed' project: reports

The U.S. government's “Operation Warp Speed” aims to deliver a coronavirus vaccine to Americans by the end of the year, drawing on top minds in pharma, government and academia to do it. And now it has an experienced Big Pharma executive leading the charge. 

With drugmakers clamoring, FDA looks to restart facility inspections delayed by COVID-19

The FDA abruptly shut down its on-site facility inspections in March, hoping to keep its employees safe during the novel coronavirus pandemic. More than two months into that moratorium, drugmakers are calling for relief—and with some new guidance, the FDA shows it might be willing to accommodate.

Providers press CMS to extend deadline on whether an ACO can quit to Oct. 31

Providers want the Centers for Medicare & Medicaid Services to extend a deadline for accountable care organizations to decide whether to leave or stay in the program as they struggle to figure out the impact of the pandemic.