|  | Statistical Considerations for FDA COVID-19 Guidance In response to the FDA guidance on COVID-19, we’re committed to highlighting specific, actionable considerations that directly address the agency’s key recommendations. Get our tips for ensuring the operational integrity and scientific robustness of your clinical trial. Premier Research. Built for BiotechSM |
Today's Rundown Featured Story | | | Tuesday, March 31, 2020 Some hospitals and health systems have been forced to furlough staff due to fewer patients coming through the door and cancellation of elective procedures because of the COVID-19 outbreak. |
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Top Stories Wednesday, April 1, 2020 Smith+Nephew is contracting with the U.K. government to build a new ventilator specifically designed for the large-scale production needed to combat the spread of COVID-19. Wednesday, April 1, 2020 The White House is eyeing Fujifilm's influenza drug Avigan as a potential coronavirus treatment—and it’s pressuring the FDA to green light emergency use during the pandemic. But the drug's side effects have deterred the agency before, and its clinical profile for COVID-19 is far from conclusive. Wednesday, April 1, 2020 There could be imminent shortages of antimalarial drugs and antibiotics that are critical to providing care for COVID-19 patients, according to data from Premier. Shortages are most common in the hospital setting and are most acute in New York, where the majority of COVID-19 patients are receiving care. Wednesday, April 1, 2020 Smith+Nephew plans to ramp up ventilator manufacturing if technology from the University of Oxford and King’s College London wins approval. Microsoft has entered a supercomputing collaboration, and Brii Biosciences is working with partners in China on antibodies. Wednesday, April 1, 2020 FierceHealthcare's ongoing coverage of how the coronavirus is impacting the healthcare industry. Wednesday, April 1, 2020 The FDA has created an emergency program to accelerate the development of treatments for the novel coronavirus. By redeploying staff, the FDA thinks it can respond to COVID-19-related requests and review protocols within 24 hours of receipt. Wednesday, April 1, 2020 The CEO of major hospital system HCA Healthcare announced he will donate the next two months of salary to a fund to help system workers struggling with reduced hours during the COVID-19 pandemic. Wednesday, April 1, 2020 With Prime Minister Boris Johnson infected and isolated in Downing Street, and other top officials similarly afflicted with COVID-19, the U.K. is joining in the testing for Gilead Sciences' much-hyped antiviral candidate remdesivir. The trial news comes as case counts surge and officials hustle to get hospitals ready for a surge in patients. Wednesday, April 1, 2020 With concerns over capacity increasing, the Trump administration gives guidance to providers on how to make one ventilator treat two patients. Wednesday, April 1, 2020 Brii Biosciences has teamed up with a Chinese hospital and university to develop antibodies against COVID-19. The partners leveraged their proximity to the initial outbreak and experience with SARS and MERS to build up a library of potentially neutralizing antibodies, putting them on track to start testing candidates in humans in the third quarter. Wednesday, April 1, 2020 NantWorks’ ImmunityBio has begun a supercomputing collaboration with Microsoft to map out the spike protein of the novel coronavirus—the means it uses to pry its way into and infect human cells. Wednesday, April 1, 2020 Reckitt Benckiser cold and flu brand Mucinex is looking to spread COVID-19 facts instead of fear. The new awareness effort encourages people to “Spread Facts, Not Fear” using simple, vibrant illustrations. Each ad presents a single piece of advice, including wash hands, avoid handshakes, stay six feet away from others, and avoid opinions and listen to experts. Wednesday, April 1, 2020 It was supposed to be an exciting time of next-gen science, where CRISPR gene editing was being used in the first series of human trials with the hope this tech could help cure a range of diseases. |
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