Today's Rundown EMA starts reviewing Gilead's remdesivir data to accelerate approval of COVID-19 antiviral Bristol Myers' leukemia hopeful snags speedy FDA review Gilead CEO: Remdesivir could be the benchmark for COVID-19 drug development [Sponsored] Connecting biotech, pharma and life sciences ecosystem to ramp up COVID-19 capabilities COVID-19 the focus, but Pfizer isn't ignoring other vaccine R&D as its pens new deal Inovio's COVID-19 vaccine claims echo Theranos, says short attack A COVID-19 treatment inspired by llamas As coronavirus strikes, crucial data in electronic health records hard to harvest FiercePharmaAsia—AZ's COVID-hit China business; GSK's $3.7B Unilever stake sale; I-Mab eyes $2B deal Chutes & Ladders—Radius CEO Høiland set to step away after 3 years Featured Story | | | Friday, May 1, 2020 The European Medicines Agency has begun a rolling review of data on Gilead’s remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients. |
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Top Stories Friday, May 1, 2020 Exactly one month after filing its multiple myeloma CAR-T for FDA approval, Bristol Myers Squibb is at it again. It’s nabbed priority review status for another blood cancer program it picked up from Celgene: a leukemia treatment aimed at keeping patients in remission. The FDA is set to make a decision by Sept. 3. Thursday, April 30, 2020 When the first data emerged Wednesday from a placebo-controlled study of Gilead’s remdesivir, analysts agreed that it “appears to help,” but it was no “silver bullet.” But Gilead CEO Daniel O’Day and NIAID Director Anthony Fauci, M.D., agree the drug could be a steppingstone to better treatments. 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. Friday, May 1, 2020 Pfizer and partner BioNTech are right in the middle of one of the most important vaccine trials in the world right now, but that doesn’t mean the Big Pharma is taking its eyes off the inoculation ball elsewhere. Friday, May 1, 2020 Inovio Pharmaceuticals’ stock has climbed higher and higher over the past month since it said it was working on a speedy COVID-19 vaccine. Thursday, April 30, 2020 Single-domain antibodies or “nanobodies” produced by llamas' immune systems have inspired a potential treatment for COVID-19 that works by binding to the spike protein on the coronavirus that causes the illness. The researchers that created the treatment have shown it neutralizes the virus in cell cultures, and they're now planning animal studies. Thursday, April 30, 2020 Over the past decade, federal officials have spent some $36 billion switching from paper to electronic health records. But the pandemic is bringing into stark relief just how far the nation is from achieving the promised benefits. Friday, May 1, 2020 AstraZeneca saw its China sales growth slow down in the first quarter, when the coronavirus outbreak was at its height there. GlaxoSmithKline is looking to offload its stake in Unilever India for $3.7 billion. I-Mab is eyeing a U.S. partner for its CD47 antibody in a potential $2 billion deal. And more. Friday, May 1, 2020 Radius CEO Høiland will step down after nearly 3 years; Roche vet Levitsky takes over at Targovax; Rome names Kapelier as first CEO. 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: 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: 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: 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 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! Pre-Boot Camp training is in session. | Take your new medicine development skills to the next level. | 