Today's Rundown Pfizer restarts trial recruitment, speeds up antiviral work against COVID-19 Merck, slower than its peers, edges into COVID-19 fight Novartis' cholesterol buster, new trial starts fall victim to pandemic: report [Sponsored] Connecting biotech, pharma and life sciences ecosystem to ramp up COVID-19 capabilities AACR: Early Syndax data broach 'undruggable' leukemia mutation Harvard pens Astellas research deal, vowing to push on despite pandemic Roche shares SMA data ahead of scrap with Biogen, Novartis AACR: Iovance details early responses to TIL cell therapy in lung cancer Congress urges FDA to better police, evaluate COVID-19 antibody tests Featured Story | | | 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. |
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Top Stories Tuesday, April 28, 2020 Almost all of Merck’s Big Pharma peers have either on their own or, increasingly, with a partner, geared up to fight the good fight against COVID-19. Tuesday, April 28, 2020 The COVID-19 pandemic has driven biopharmas left and right to hit pause on clinical trials, and Novartis is no exception. The Swiss pharma has stopped enrolling patients in a trial of its cholesterol fighter inclisiran even as it expects its trials to stay on course in the long term. Monday, April 27, 2020 The life sciences industry is moving in record time to beat COVID-19, but it must connect with partners across the entire ecosystem to ramp up capabilities and deliver the billions of vaccines doses and treatments needed. Monday, April 27, 2020 Unlike other gene fusions, which have led to targeted therapies for various cancers, the MLL-r fusion has eluded researchers for decades. Early data from a small leukemia trial give the first clue to how to treat patients with this mutation, long thought to be undruggable. Tuesday, April 28, 2020 With COVID-19 still sweeping across the U.S. and daily cases and deaths making for grim reading, biomedical R&D deals are not an easy sell. Tuesday, April 28, 2020 Roche has presented more of the data that could enable it to challenge Biogen and Novartis for the spinal muscular atrophy (SMA) market. The readout shows 29% of infants with the most severe form of the disease could briefly sit without support after taking risdiplam, adding to evidence that Roche has a viable challenger for the market. Monday, April 27, 2020 Moffitt researchers unveiled data at AACR showing that two patients in an early trial of Iovance's tumor-infiltrating lymphocytes in non-small cell lung cancer achieved complete responses that have lasted more than a year. But data from larger trials may be needed to parse out the effectiveness of the cell therapy versus other treatments the patients received. Monday, April 27, 2020 Members of Congress have called on the FDA to re-evaluate its stance toward COVID-19 antibody tests. Since mid-March, the agency has allowed diagnostic developers to bring their products to market without any outside evaluation that the results they produce are accurate. 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. Medical Affairs Strategic Summit (MASS) East April 14-16, 2020 | New Brunswick, NJ PEGS Boston – The Essential Protein Engineering & Cell Therapy Summit May 4-8, 2020 | Boston, MA 8-week Online Courses in Life Sciences Law and Compliance Virtual Course | May 31st, 2020 European Healthcare Compliance Certificate Program June 2-5, 2020 | Paris, France BIO 2020 Now Fully Virtual: Announcing BIO Digital June 8-11, 2020 | Virtual Event Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. | 