Today's Rundown Featured Story | Tuesday, April 14, 2020 A phase 1 trial of Moderna’s COVID-19 vaccine candidate has begun enrolling subjects at the highest dose. Moderna shared the update on the COVID-19 study alongside news that people in another trial had anti-Zika antibodies after receiving the biotech’s vaccine against that virus. |
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Top Stories Tuesday, April 14, 2020 Sanofi and GlaxoSmithKline, two of the world’s biggest vaccine players, may be competitors, but the COVID-19 pandemic has now made them partners. The pharma giants are teaming up to develop a coronavirus shot—and to scale up manufacturing lickety-split. Tuesday, April 14, 2020 It’s a pretty grim story in Alzheimer’s research, with years of flops and setbacks against the memory-wasting disease. Tuesday, April 14, 2020 Five Prime Therapeutics has had bumpy few years, losing a couple of CEOs, facing layoffs and coming up empty on a pancreatic cancer trial. Now, it’s recruited a new CEO to steady the ship: Thomas Civik, who spent more than a decade at Genentech commercializing cancer meds. Tuesday, April 14, 2020 FDA has put Alnylam’s RNAi treatment for the polyneuropathy of hereditary transthyretin-mediated amyloidosis on its regulatory fast track. Alnylam secured the designation for the candidate, vutrisiran, ahead of the anticipated readout from a phase 3 trial early next year. Tuesday, April 14, 2020 San Diego biotech MEI Pharma has upped its pact with Tokyo, Japan-based Kyowa Kirin in a cost-sharing deal centered on MEI’s experimental oncology asset. Tuesday, April 14, 2020 Four months after inking its first Big Pharma partnership, Cerevance is topping up its coffers with a $45 million raise. The proceeds will push the company’s lead Parkinson’s disease program through phase 2 and move several earlier-stage prospects into the clinic. Monday, April 13, 2020 Clinical genomics researchers at Rutgers University have received the FDA’s first emergency authorization for a COVID-19 diagnostic test that uses easy-to-collect saliva samples instead of the more difficult deep nose swabs. Monday, April 13, 2020 Researchers led by the Emory School of Medicine discovered proteins that govern how cells derive energy from glucose are elevated in the brains and cerebral spinal fluid of patients with Alzheimer's disease. The findings could be used to define new drug targets and develop diagnostics for early detection of the disease. Some drugmakers work for years to take one of their meds from launch to blockbuster status—a journey defined by competition, market, branding and a dash of luck. But even for pharma's biggest whales, growth-minded executives have a question: What have you done for me lately? Resources 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: Epsilon Download this e-book to learn 9 ways to enhance the customer experience within healthcare marketing. 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. |