|  | 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 | | | Thursday, April 2, 2020 After The Wall Street Journal first broke the news this week, Amgen and new partner Adaptive Biotechnologies have confirmed they are the latest pharma-biotech duo joining forces against the pandemic. |
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Top Stories Thursday, April 2, 2020 In the quest to treat COVID-19, chloroquine and hydroxychloroquine have drawn more attention than any other drugs. But while the FDA issued an emergency green light for their use against coronavirus, European regulators are limiting them strictly to clinical trials. Thursday, April 2, 2020 Almost 22 years ago, Sumana Reddy, M.D., and two other doctors set up a family medicine practice in the rural area of Salinas, California. Now she worries the coronavirus could be the death of it. Thursday, April 2, 2020 As the pandemic begins to strain the U.S. healthcare system, fears of widespread infection among healthcare providers is only growing. But Big Pharma has thousands of medical employees in its ranks, and top drugmakers are now allowing their workforces to jump into the battle. Thursday, April 2, 2020 Novo Nordisk doesn't expect shortages, but pharmacies could temporarily run out of medicines as demand spikes. Plus, an expert told SVB Leerink analyst Geoffrey Porges the U.S. "missed the window" to minimize the outbreak, the analyst wrote. Wednesday, April 1, 2020 FierceHealthcare's ongoing coverage of how the coronavirus is impacting the healthcare industry. Thursday, April 2, 2020 In the wake of the COVID-19—which has caused uncertainty and hardship across the economy including the healthcare sector—the Dallas-based hospital giant withdrew its previously announced first-quarter and full-year financial outlook for 2020. Thursday, April 2, 2020 Researchers at the University of Pittsburgh School of Medicine developed a COVID-19 vaccine that uses pieces of the virus' spike protein to create immunity and that can be delivered into the skin with a Band-Aid-like patch. They're planning to apply to the FDA for approval to start clinical trials soon. Thursday, April 2, 2020 Humana is launching new initiatives aimed at easing the administrative burden on providers as they treat patients with COVID-19. Wednesday, April 1, 2020 Microsoft is warning hospitals that sophisticated ransomware attacks are trying to exploit remote workers to gain access to their networks. The tech giant recommends immediate actions hospitals should take to reduce the risk of an attack. Thursday, April 2, 2020 A new and unproved COVID-19 cell therapy from a New Jersey biotech has been given a quick trial approval by the FDA, coming just days after President Donald Trump’s personal attorney and former New York City Mayor Rudy Giuliani pushed for the med to be trialed ASAP. Thursday, April 2, 2020 BD will begin offering a point-of-care COVID-19 antibody assay, which operates like a combination of a blood glucose test and a home pregnancy test. Thursday, April 2, 2020 Roche Canada is looking for a few good ideas to fight COVID-19, and it needs them soon. Its recently launched Canada-specific innovation challenge has an April 10 deadline—and the promise of up to $100,000 to fund development. |
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