| They’re here. The first, early results from a placebo-controlled study of Gilead’s antiviral hopeful have arrived, courtesy of NIAID. Far from a cure, remdesivir did help hospitalized COVID-19 patients recover faster, by about four days—important proof of its concept, describes Dir. Anthony Fauci. But that data could be enough for the FDA to grant a swift emergency approval, according to some administration officials and Wall Street analysts, while other countries look to move forward with the drug as well. | |
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Featured Story | | | Wednesday, April 29, 2020 After dribs and drabs surfacing about Gilead’s COVID-19 hopeful, remdesivir, the first data from a placebo-controlled study are here—at least, an early look at them. Remdesivir cut recovery time for hospitalized COVID-19 patients by four days, or 31%, in an NIH-sponsored study pitting the drug against placebo in more than 1,000 patients. |
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|  | The need for real-time data in a COVID-19 era. Join Parexel experts during this live webinar as they analyze the role of Real-World Evidence (RWE) and how it supports the urgent need in emerging therapies for COVID-19. Register Now! |
Top Stories Of The Week Wednesday, April 29, 2020 As investors and much of the world await any glimmer of hope for treating the ongoing pandemic, it shouldn’t be much of a surprise that Gilead Sciences' shares rocketed up on word that one key trial was positive and details were out in another for severe patients. Monday, April 27, 2020 Japanese Prime Minister Shinzo Abe is set to grant Gilead’s experimental COVID-19 drug remdesivir a special, speedy approval, despite it failing to show any definitive clinical signs that it works. Friday, April 24, 2020 Johnson & Johnson has joined a suite of drugmakers hoping to pump out a COVID-19 vaccine as fast as possible. Now, it's pairing with contract manufacturer Emergent BioSolutions to gear up for its potential vaccine launch. Friday, April 24, 2020 Sanofi CEO Paul Hudson's not concerned about meeting an optimistic 18-month timeline for developing a COVID-19 vaccine. He's worried there won't be enough doses available. But he figures Sanofi and its partner GlaxoSmithKline have the world’s best chance at meeting demand. Tuesday, April 28, 2020 In its first-quarter results posted today, Big Pharma Pfizer said it is beginning to reopen some stalled trials and is now months ahead of schedule to develop a potential new med against COVID-19. Wednesday, April 29, 2020 Weeks after launching their own COVID-19 molecular testing initiatives, lab giants Quest Diagnostics and LabCorp have begun offering antibody tests nationwide for the next phase of the coronavirus pandemic. Monday, April 27, 2020 Sanofi and Regeneron may be late to the PD-1/PD-L1 party with sixth-to-market Libtayo, but they sure don’t intend to miss out on the lucrative lung cancer market. And with just-released data, they're on their way to a chance to wrest share away from Merck's leader, Keytruda. Monday, April 27, 2020 With a study of its Yescarta therapy in tandem with Roche’s Tecentriq, Gilead Sciences was aiming to find out whether adding a PD-1/L1 immuno-oncology drug to CAR-T treatment could improve outcomes for lymphoma patients. But after a small, early study, there’s still no evidence it can. Friday, April 24, 2020 Researchers at UT Southwestern Medical Center discovered that a protein called calcineurin plays a key role in blocking the ability of heart muscle to regenerate after the first week of life. The finding could be used to develop treatments that reverse this process, offering new strategies for repairing hearts damaged by heart attacks, high blood pressure, viruses and more, they said. Thursday, April 30, 2020 In order to boost manufacturing for a possible COVID-19 therapy, Fujifilm is working with the Bill Gates-backed COVID-19 Therapeutics Accelerator to set aside production space to bring global distribution quickly up to speed. Enrollment Showcase | | | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
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Resources Sponsored by: Quotient Sciences Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug. Download the whitepaper. Sponsored by: Lonza This whitepaper summarises approaches for modulating antibody effector functions and pharmacokinetics, and provides examples of antibodies in clinical studies. Sponsored by: Blue Latitude Health Report: Think you’re patient-centric? Think again. Find out how patients really feel about patient-centricity. Learn what they would like to experience along with tools and tips for maximising patient engagement across the product life cycle¬ – from clinical trials to service design and creative campaigns. Sponsored by: BBK Worldwide Leverage strategic solutions to respond to immediate challenges to patient and site engagement from COVID-19, and learn to maximize the FDA guidance on the conduct of clinical trials during a pandemic. Sponsored by: Oracle Health Sciences The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need. Sponsored by: Clinical Ink This white paper includes a Phase III case study and discusses BYOD advantages and misconceptions, regulatory, copyright, and equivalency considerations. Sponsored by: Research Solutions Turn your drug failures into competitive advantage. Sponsored by: ICON How will US payers evaluate and manage digital therapeutics? Get insights and recommendations on successful market access considerations. Sponsored by: Copyright Clearance Center Despite advances in content aggregation and search, silos still limit the free flow of data and analytics. So, what can be done, and how can you get more value from the data you already have? Sponsored by: Altran This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future. Sponsored by: Patheon, by Thermo Fisher Scientific Poorly soluble molecules hindering your workflow? Sponsored by: eClinical Solutions Key findings from the 2019 Life Sciences Data & Analytics Survey conducted by the Tufts Center for the Study of Drug Development will be unveiled during this live webinar led by industry expert and study lead, Ken Getz, Director of Sponsored Programs and Associate Professor. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. Sponsored by: Clarify Health Pharma launch teams spend significant resources on data and analytics with limited ROI. Read this case study to learn how a Life Sciences company identified two times more patients best suited for therapy, using Clarify’s deep and longitudinal patient and HCP insights. | 
