| | Collecting Quality Data in Psychiatric Trials Understanding interactions among the many factors that give rise to mental illness is a complex task. Learn how to identify and mitigate these elements early on to help ensure trial data accurately captures your compound’s safety and efficacy potential. Premier Research. Built for BiotechSM |
Today's Rundown Amgen sees no 'significant delays' from pandemic to novel KRAS cancer drug COVID-19 not expected to 'significantly delay' Genfit's phase 3 NASH readout ElevateBio reels in $170M to push 6 cell, gene therapy programs Lilly pays Sitryx $50M upfront for preclinical autoimmune assets Pandemic sees one-quarter of investigators halting trial enrollment: poll Akero’s NASH drug cuts liver fat in phase 2, but COVID-19 may delay full data ACC: Regeneron's Praluent sidekick cuts cholesterol in half—even in hard-to-treat patients COVID-19: Bio researchers race to repurpose everything from antiviral to anticancer discoveries Disaster at Amarin: Patent loss spurs stock spiral, but all hope might not be lost Featured Story | | | Tuesday, March 31, 2020 Amgen has become the latest biopharma to try to figure out the hit it may take to its pipeline timings amid the COVID-19 pandemic. |
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Top Stories Tuesday, March 31, 2020 Genfit has told investors that it does not expect the COVID-19 pandemic to “significantly delay” the unblinding of its phase 3 nonalcoholic steatohepatitis data. The database was locked at the end of February but will only be unblinded after the FDA has provided feedback. Monday, March 30, 2020 Barely a year after launching with $150 million to build cell and gene therapy companies, ElevateBio is at it again. This time, it’s picking up another $170 million to propel six programs into the clinic and get its centralized R&D and manufacturing hub up and running. Tuesday, March 31, 2020 Eli Lilly has paid Sitryx $50 million (€46 million) upfront for global rights to up to four autoimmune drugs. The deal sees Lilly commit to up to $820 million in development milestones for the chance to work with Sitryx on drugs that manipulate intracellular metabolic pathways. Tuesday, March 31, 2020 A new survey by Clinical Research IO has found that nearly one-quarter of polled trial investigators have stopped enrolling new patients due to the COVID-19 pandemic. Tuesday, March 31, 2020 Two years ago, Akero Therapeutics licensed a diabetes drug from Amgen in hopes that it could move the needle in fatty liver disease. Now, it looks like that bet is starting to pay off—the company unveiled phase 2a data showing the drug beat placebo at reducing liver fat in patients with nonalcoholic steatohepatitis (NASH). Monday, March 30, 2020 Regeneron revealed last summer that its latest cholesterol fighter, evinacumab, cut “bad” cholesterol in half for patients with a rare genetic disorder. Now, in full results presented virtually at the annual meeting of the American College of Cardiology (ACC), together with the World Congress of Cardiology, the drug did even better in a group of particularly hard to treat patients. Monday, March 30, 2020 Several academic institutions and biotech startups are stepping up with ideas of how to take existing research and pivot it towards potential solutions to COVID-19. It may take several months for these efforts to bear fruit, at which point this pandemic may have ended, but the scientists leading the charge believe their discoveries will help fend off future outbreaks. Monday, March 30, 2020 Only months ago, hopes for Amarin, the maker of fish-oil derivative Vascepa, were sky high after the FDA expanded the drug's label to include its heart-helping results. But those blockbuster hopes have come crashing down after a judge invalidated Vascepa's underlying patents. Enrollment Showcase | | | Presented by: Global EMBA for Healthcare & the Life Sciences, University of Toronto Prepare to step up in your career, build the expertise you need to reshape your organization, and explore opportunities worldwide. |
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Resources 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: Metabolon Metabolomics can help you streamline your drug development process by providing the framework to make a stronger, more confident, and more valuable case for a molecule in a shorter timeframe. Sponsored by: Epsilon Download this e-book to learn 9 ways to enhance the customer experience within healthcare marketing. Sponsored by: Reprints Desk/Research Solutions 3 ways you may be overspending on scientific literature access, and how to fix them. Sponsored by: Baxter When different drug products are produced in shared facilities, potential for cross-contamination needs to be addressed. Outsourcing to a CMO with experience in multiproduct facilities can be an option. Sponsored by: WCG Metrics Champion Consortium Ineffective measurement could mean wasting both time and money. This whitepaper showcases a custom-built Metric Maturity Model that helps illustrate and define the process for measuring the right things the right way. Sponsored by: The Kinetix Group Read about the innovative ways payers are making smart moves in the healthcare game. 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. Medical Affairs Strategic Summit (MASS) East April 14-16, 2020 | New Brunswick, NJ BioBasics 101: The Biology of Biotech April 16-17, 2020 | Philadelphia, PA Drug Development Immersion April 23-24, 2020 | Boston, MA European Healthcare Compliance Certificate Program June 2-5, 2020 | Paris, France U.S. Healthcare Compliance Certificate Program June 8-10, 2020 | Newark, NJ BIO International Convention June 8-11, 2020 | San Diego, CA 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. | 