Today's Rundown Genfit's elafibranor en route to NASH graveyard with phase 3 flop Moderna nabs FDA fast-track tag for its COVID-19 vax Skyhawk Therapeutics boosts Merck collab pact with added targets, upfront and biobucks [Sponsored] The COVID-19 crisis: Five ways pharmaceutical leaders can rise to the challenge Novartis-backed Gamida hits goal in phase 3 cancer trial Kriya snags $80.5M to push gene therapy beyond rare disease Next-gen biotech Caribou Biosciences nabs Array (now Pfizer) cancer R&D exec as clinical lead Novavax scores $384M deal, CEPI's largest ever, to fund coronavirus vaccine work Regeneron links with Univ. of Colorado to sequence 450,000 patients for drug research Featured Story | | | Monday, May 11, 2020 Genfit’s lead drug failed a phase 3 study in nonalcoholic steatohepatitis (NASH), joining a growing number of fatty liver prospects that have bitten the dust. The drug, elafibranor, did not beat placebo at improving NASH symptoms without making liver scarring worse, interim data show. The company will analyze those data to see whether it has a path forward in NASH. |
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Top Stories Tuesday, May 12, 2020 In what will be of little surprise to anyone, the FDA has hitched its fast-track tag to Moderna’s speedy attempt at an mRNA COVID-19 vaccine. Tuesday, May 12, 2020 Merck has decided to double down on its research pact with startup Skyhawk Therapeutics as it expands the deal to now also cover autoimmune and metabolic diseases. Monday, May 11, 2020 Amid the COVID-19 crisis, Takeda leaders share five ways to adjust to protect people’s families, colleagues and community, while maintaining a commitment to the people who need Takeda’s medicines. Tuesday, May 12, 2020 A phase 3 trial of Gamida Cell’s omidubicel in blood cancer patients has met its primary endpoint, sending the biotech’s stock up as much as 86% in premarket trading. The study found Gamida’s cells cut the time to neutrophil engraftment, suggesting the drug has benefits over umbilical cord blood. Tuesday, May 12, 2020 Many gene therapies are designed for monogenic diseases, that is, ailments caused by a defect in a single gene. But these treatments are just “scratching the surface” of what gene therapy can accomplish. Enter Kriya Therapeutics, which raised $80.5 million to develop gene therapies for more complex—but more common—diseases like diabetes. Tuesday, May 12, 2020 After a relatively quiet few years, Caribou Biosciences has hired Cherry Thomas, M.D., as its new senior vice president of clinical development. Monday, May 11, 2020 After winning a small grant for early vaccine work in March, Novavax just secured the largest-ever investment from CEPI, a global coalition aiding COVID-19 vaccine development. The deal, worth up to $384 million, offers funding not only for clinical work, but manufacturing scale-up if the candidate proves itself. Monday, May 11, 2020 Regeneron Pharmaceuticals launched a new initiative that plans to sequence the DNA of 450,000 patients and compare the results with their health records to support the company’s drug discovery and personalized medicine efforts. | | Experts in our field; with 20+ years’ experience in Viral Vector & plasmid DNA (R&D, High Quality and GMP) manufacture for pre-clinical, clinical & commercial supply. Take a virtual tour of our facilities & find out more about our expansion project. |
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 Presented by: Optum The immediacy of EHR data availability can be significantly impactful, particularly as the health care system works to address COVID-19. Download this whitepaper to learn more. Sponsored by: Patheon, by Thermo Fisher Scientific Continuous Manufacturing vs. Batch for Oral Solid Dose Sponsored by: Cenduit, LLC Download this case study to read about how Cenduit navigated these challenges, and successfully supports the trial sponsor to execute the umbrella trial with agility. Sponsored by: Patheon, by Thermo Fisher Scientific Download this whitepaper to learn more about the importance of an integrated approach to formulation. Sponsored by: Acorn AI by Medidata, a Dassault Systèmes company Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI. 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. Sponsored by: Recro Gainesville Wurster processing is a versatile technique for developing and manufacturing multiparticulates for modified release dosage forms. Read this whitepaper to determine whether Wurster processing is the right option for your project. Sponsored by: AMRI In this webinar, the featured speaker will explore the key advances and critical hurdles for translating these emerging molecular biology technologies into real-world applications and commercial processes. 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: 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: 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: 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. 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 PEGS Virtual Interactive Summit Virtual Event | June 2-26, 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. | 