|  | 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 | | | Friday, April 3, 2020 Provider groups and health systems are imploring HHS to provide direct assistance to hospitals as more and more systems are furloughing workers while trying to expand bed capacity. |
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Top Stories Friday, April 3, 2020 GlaxoSmithKline has teamed up with Xiamen Innovax Biotech to evaluate a vaccine against the novel coronavirus behind the COVID-19 pandemic. The agreement gives Innovax access to a GSK adjuvant to enhance the immune response triggered by its recombinant protein-based vaccine. Friday, April 3, 2020 Sanofi, the maker of a branded hydroxychloroquine drug called Plaquenil, is producing as much drug as it can, CEO Paul Hudson told Reuters. But there are limits amid a pandemic. Some employees are having to step aside if they show symptoms, he said. Friday, April 3, 2020 FierceHealthcare's ongoing coverage of how the coronavirus is impacting the healthcare industry. Friday, April 3, 2020 The U.K. government is planning to enroll the world's largest clinical trial to treat COVID-19, but its health department is warning it might take a while to get up to speed. Friday, April 3, 2020 Amid concerns about dwindling stockpiles of protective equipment, pharmacists are expressing frustration with their hospitals’ ability to obtain masks from the national stockpile. Friday, April 3, 2020 Late last month, the FDA began giving developers of remote patient monitoring devices some extra leeway when it comes to making marketing claims, allowing them to pitch their use to hospitals responding to the COVID-19 crisis. Friday, April 3, 2020 A coronavirus test made by Abbott Laboratories and introduced with considerable fanfare by President Donald Trump in a Rose Garden news conference this week is giving state and local health officials very little added capacity to perform speedy tests needed to control the COVID-19 pandemic. Friday, April 3, 2020 The Cannes Lions canceled its advertising creativity conference for 2020 after media reports that many large ad agencies planned to opt out or were seriously considering it. While a virtual festival was reportedly considered, organizers decided to close the show for the year and look forward to the next one in June 2021. Friday, April 3, 2020 Amid the COVID-19 pandemic new drug rollouts, especially for chronic diseases, face an uphill fight, analysts figure. Bristol Myers has already postponed a big new rollout, and Novartis, Gilead Sciences and Roche could see their closely watched prospects held up by regulatory delays. Friday, April 3, 2020 The FDA granted its first emergency authorization for a rapid antibody blood test for COVID-19, developed by Cellex, allowing people to gauge a person’s immune response to the novel coronavirus. Friday, April 3, 2020 Drugmakers across the board are rolling already approved drugs into late-stage clinical trials in an effort to find a speedy therapy for COVID-19. Now, two more are joining the party, with Swiss drugmaker Novartis and partner Incyte set to test their blockbuster JAK inhibitor. Friday, April 3, 2020 As many as 35 million people could drop out of employer-sponsored coverage amid COVID-19, according to a new analysis. Friday, April 3, 2020 Online medical appointment booking company Zocdoc has added telehealth appointments to its platform in response to the spike in demand for virtual care. Several startups also have expanded their telehealth services to relieve strain on the system. Find out what services the companies are offering. Friday, April 3, 2020 Two German biotech companies at the start of a race to create new vaccines against the COVID-19 pandemic are warning the EMA and FDA they will need traditional clinical trial hurdles removed if governments want the inoculations as quickly as possible. |
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