Today's Rundown Featured Story | | | Thursday, April 23, 2020 Ex-BARDA chief Rick Bright has launched an astonishing attack against “politics and cronyism” days after being kicked out of the agency leading the government’s push for a COVID-19 vaccine. |
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Top Stories Thursday, April 23, 2020 Affinivax, the company looking to unseat the world’s best-selling vaccine, reeled in $120 million to advance its pipeline. But with its lead program, a Prevnar 13 challenger that covers 24 strains of pneumococcus, fully financed by a partnership with Astellas, where will it deploy the cash? Wednesday, April 22, 2020 What do Parkinson’s disease and diabetes have in common? Nitrome Biosciences thinks it can treat both, along with other aging-related diseases, by targeting a new class of enzymes—and it’s raised $38 million from the likes of Sofinnova Partners and AbbVie Ventures to prove that theory out. Thursday, April 23, 2020 Two years ago, Accent Therapeutics got off a $40 million series A to target RNA-modifying proteins in cancer; now, in the middle of a pandemic, it’s still managed to bring in a respectable $63 million second funding round. Thursday, April 23, 2020 Sanofi has posted the data that led it to start four phase 3 trials of its Principia Biopharma-partnered multiple sclerosis drug SAR442168. The phase 2 linked the BTK inhibitor to relative reductions in new lesions of 85% or more, but criticism of the study design means doubts remain as the program enters the pivotal stage. Wednesday, April 22, 2020 The Trump administration’s actions have raised concerns that it could inadvertently unleash a wave of billing fraud and abuse and risk patient safety—especially if officials yield to industry pressure to make many of the emergency policy changes permanent. Thursday, April 23, 2020 As CROs report their first-quarter financials, Icon has issued some grim warnings about how much COVID-19 and the resultant lockdowns are hitting its business. Wednesday, April 22, 2020 Immunomedics has weathered two FDA snubs to win a blockbuster approval for its antibody-drug conjugate sacituzumab govitecan in triple-negative breast cancer. And the company plans to launch right away despite the COVID-19 pandemic. Thursday, April 23, 2020 CAR-T and TCR-T therapies that involve engineering a patient’s own immune cells with antigen-specific receptors have revolutionized blood cancer treatment. Now, scientists at Duke-NUS Medical School are exploring the possibility of turning the approach against COVID-19. Resources 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: Applied BioMath Learn how we used a tiered model-based approach of a bispecific antibody to appropriately cover multiple antigen pairs to help teams with informed antibody design, prioritization of experiments, and triaging of challenging antigen pairs 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: Outer Edge Technology To survive in these challenging conditions, companies need to promptly address business continuity issues - especially the remote delivery of data and voice solutions. See how Outer Edge can help. 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: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. 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. | 
