Today's Rundown It’s too soon to assume success for Moderna’s COVID-19 vaccine: analyst Atea raises $215M to support midphase COVID-19 antiviral trial Cowen raises $493M fund, further expanding biotech VC pot AstraZeneca-partnered RNA player Silence plans Nasdaq listing Eiger's progeria drug nabs speedy review Pandion recruits Gilead alum Sundy as CMO Cell therapy repairs multiple sclerosis damage and restores motor functions in mice New Zolgensma 'inflection point' is here as Novartis snags EU nod for SMA gene therapy Verily seeks to establish new COVID-19 'Baseline' with coronavirus antibody research project Featured Story | | | Wednesday, May 20, 2020 Evercore ISI analyst Umer Raffat analyzed the data Moderna released earlier this week on its experimental COVID-19 mRNA vaccine and found some shortcomings that he believes the company will have to address in phase 3 trials. They include questions about the validity of comparators the company used and the durability of protection the vaccine offers. |
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Top Stories Wednesday, May 20, 2020 Bain Capital Life Sciences has powered Atea Pharmaceuticals to a $215 million financing round. The series D sets Atea up to run a phase 2 trial of its oral purine nucleotide prodrug in people hospitalized with moderate cases of COVID-19. Tuesday, May 19, 2020 Cowen Healthcare Investments has raised a $493 million fund, breezing past its original goal by close to $100 million. The fund closure positions Cowen to continue following an investment strategy that has seen it invest in biotechs such as Akouos, AM-Pharma and Keros Therapeutics in recent months. Wednesday, May 20, 2020 Silence Therapeutics has outlined plans to list its stock on Nasdaq, giving it access to U.S. investors to support the progress of its internal and AstraZeneca-partnered RNA therapeutics. Wednesday, May 20, 2020 Children with progeria age too quickly, developing symptoms common in much older people. Treatments focus on managing symptoms, but the FDA could approve a drug that changes the course of the rare, genetic disease later this year. Eiger BioPharmaceuticals scored a priority review tag for its progeria prospect, lonafarnib, with a target action date of Nov. 22. Tuesday, May 19, 2020 On the heels of an $80 million series B round, Pandion Therapeutics nabbed itself a new chief medical officer. John Sundy, M.D., Ph.D., joins from Gilead, where he led clinical research in its inflammation and respiratory therapeutics unit. Sundy arrives at Pandion as it moves its lead program, a treatment for ulcerative colitis, toward the clinic. Tuesday, May 19, 2020 University of Rochester spinoff Oscine Therapeutics is developing a method for using progenitor glial cells to regenerate myelin, the protective sheath around axons that's lost in multiple sclerosis. In mouse models of MS, the cell therapy rebuilt myelin and restored motor functioning. Wednesday, May 20, 2020 As the number of U.S. spinal muscular atrophy patients Zolgensma treats each quarter stabilizes, Novartis is counting on a set of “inflection points” for future growth. Now, it has reached one of them, nabbing an EU nod that enables it to reach almost all patients there under the age of 5. Monday, May 18, 2020 Verily has launched a new clinical research effort focused on COVID-19 antibody testing and exploring the body’s immune response to the novel coronavirus. | | LabConnect is now offering global analytical and operational services to meet your COVID-19 testing requirements. We offer viral load testing by RT-qPCR and multiple COVID-19 screening assays. Connect with LabConnect today. We are here to help. |
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Resources 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 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 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: Frontage Laboratories, Inc. Listen to our brand-new Frontage Laboratories podcast where you’ll take home tips for developing residual host cell proteins ELISA assay for biopharmaceutical products using commercial kits. Wednesday, May 20, 2020 | Time: 10am-3.30pm (BST) Join us for a day of discovery as global experts in Cardiology, Pharmacology and Diabetes discuss state of the art methods in early phase clinical research. Sponsored 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: Oracle Health Sciences Patient-facing digital technologies are playing an important role in clinical trials for new drugs and medical devices, to the point where conducting virtual trials is becoming mainstream. But terms like remote trials, direct-to-patient trials, hybrid trials, decentralized trials, and more all add to the confusion of what makes a trial "virtual." Sponsored by: Outer Edge Technology Businesses must maintain pre-pandemic levels of productivity with smaller IT budgets. Learn why an effective Cloud Strategy is imperative for success in these unprecedented times. Presented by: Rousselot | May 28, 2020 | 11am ET / 8am PT / 5pm CEST You are invited to join Rousselot Biomedical for an insightful webinar on excipients for vaccine formulation. Highly purified gelatins can help accelerate vaccine development. 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. 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. | 