|  | 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 | | | Monday, March 30, 2020 A drumbeat of anecdotal evidence and high-level praise for hydroxychloroquine in coronavirus patients have spurred the FDA to authorize it for emergency use. That means doctors can prescribe it to patients without other options—and in COVID-19, their only other options are clinical trials. |
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Top Stories Monday, March 30, 2020 Two more national insurers are waiving member cost-sharing for inpatient treatment related to COVID-19. Monday, March 30, 2020 Johnson & Johnson has joined with a U.S. government agency to commit $1 billion to development of a COVID-19 vaccine. J&J plans to have a vaccine in the clinic by September, win emergency use authorization early next year and add capacity to make more than 1 billion doses. Monday, March 30, 2020 Battelle received an emergency go-ahead from the FDA over the weekend to deploy its decontamination system for personal protective equipment, allowing healthcare workers to clean and reuse scarce N95 respirator masks. Monday, March 30, 2020 Aiming to help supply a 2,000-patient COVID-19 study at the University of Washington, Novartis will donate 20,000 doses of anti-malaria med hydroxychloroquine. The drugmaker made a previous commitment to donate 130,000 doses of the drug worldwide. Monday, March 30, 2020 FierceHealthcare's ongoing coverage of how the coronavirus is impacting the healthcare industry. Monday, March 30, 2020 Several academic institutions and biotech startups are stepping up with ideas of how to take existing research and pivot it towards potential solutions to COVID-19. It may take several months for these efforts to bear fruit, at which point this pandemic may have ended, but the scientists leading the charge believe their discoveries will help fend off future outbreaks. Saturday, March 28, 2020 Abbott is launching a rapid coronavirus test able to deliver positive results in as little as five minutes from a tabletop box the size of a small toaster oven. Monday, March 30, 2020 The AMA released guidance to help retired physicians navigate issues from licenses to medical malpractice liability as they go back to work to help combat COVID-19. Monday, March 30, 2020 Patients living with chronic conditions are still going to the doctor’s office despite COVID-19, because most really don’t have a choice. So Outcome Health is using its point-of-care digital communications network to put information and educational messages in waiting and treatment rooms around the country. Monday, March 30, 2020 For drugmakers with production in China, the manufacturing problems created by the COVID-19 outbreak are only part of the difficulty. As flights from China contract and prices double, the logistics of getting products out of China is a major undertaking. Monday, March 30, 2020 Will Gilead Sciences make a fortune out of remdesivir if the antiviral proves itself against the novel coronavirus? CEO Daniel O'Day said the Big Biotech will “work to ensure affordability and access so that remdesivir is available to patients with the greatest need” if it’s approved. But with a large pool of potential patients, there's plenty of room for sales. Monday, March 30, 2020 Fujifilm says it is prepared to ramp up production of Avigan for any country that wants to try it as a potential treatment for COVID-19. But even as it has restarted production, the Japanese drugmaker feels compelled to set the record straight about the influenza drug. Monday, March 30, 2020 As more Americans are urged to stay at home amid the COVID-19 crisis, it’s not just physical health that’s going largely digital—it's behavioral health, too. Monday, March 30, 2020 Healthcare providers and suppliers throughout the country can start receiving accelerated and advance payments from the Medicare program to offer emergency funding and address cash flow issues caused by COVID-19 disruptions. |
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