Today's Rundown Gilead's filgotinib phase 3 hits primary endpoint but details dampen hopes CanSino adds mRNA to COVID-19 vaccine efforts with Precision NanoSystems deal Day One debuts with $60M to change cancer care—starting with children AstraZeneca scores $1.2B from U.S., signs up to deliver hundreds of millions of COVID-19 vaccines SR One fuels HotSpot's $65M B round to fund allosteric R&D Nautilus emerges with $76M to become the 'Illumina of proteomics' Kadmon’s graft-versus-host disease med on track for 2020 filing Harvard animal studies suggest COVID-19 protection can come from previous infection or DNA vaccine GSK taps Mammoth Biosciences to develop a CRISPR-based, over-the-counter coronavirus test Featured Story | | | Thursday, May 21, 2020 A phase 2b/3 trial of Gilead Sciences' and Galapagos’ filgotinib in ulcerative colitis patients has met its primary endpoint. Yet, with the lower dose missing a key endpoint, investors responded negatively to the data, sending shares in Galapagos down 7% in early trading in Amsterdam. |
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Top Stories Wednesday, May 20, 2020 CanSino Biologics is already testing a recombinant conronavirus vaccine in China, but it’s jumping on the mRNA vaccine bandwagon through a licensing deal with Precision NanoSystems. The latter will design the vaccine, while CanSino will pick up preclinical and clinical development, regulatory activities and commercialization. Thursday, May 21, 2020 Day One Biopharmaceuticals is launching with a $60 million series A from Canaan, Access Biotechnology and Atlas Venture to develop new cancer treatments for children, but that could be used in adult patients, too. Its first program? A RAF inhibitor from Sunesis Pharma that was previously licensed by Takeda. Thursday, May 21, 2020 Only days after Moderna reported positive early results for its potential COVID-19 vaccine, AstraZeneca has stolen the spotlight back. On Thursday, the U.K. drug giant scored a $1 billion contribution from the United States for development, production and delivery of its potential shot starting this fall. Thursday, May 21, 2020 HotSpot Therapeutics has raised a $65 million series B to fund development of allosteric medicines. The financing, which was led by GlaxoSmithKline’s SR One, positions HotSpot to move treatments for autoimmune disease and rare metabolic conditions into the clinic. Thursday, May 21, 2020 The vast majority of FDA-approved drugs target proteins, which makes sense because “they’re the machinery inside cells that make your body work,” says Sujal Patel, co-founder and CEO of Nautilus Biotechnology. What doesn’t make sense, he says, is we haven’t figured out a way to effectively measure proteins the same way we measure genes. Thursday, May 21, 2020 Kadmon’s belumodsil curbed graft-versus-host disease in nearly three-quarters of patients in a pivotal study, teeing up an FDA filing in the fourth quarter. After six months of treatment, the drug improved symptoms of graft-versus-host disease (GVHD) in 73% of patients who took the drug once a day and 74% of patients who took it twice a day. Thursday, May 21, 2020 Two animal studies out of Harvard showed DNA vaccines against COVID-19 generated similar levels of antibodies that can neutralize the virus as the actual infection does. That will likely fuel enthusiasm for efforts to rapidly develop vaccines against the disease, though the researchers warned there are still several unanswered questions. Thursday, May 21, 2020 GlaxoSmithKline’s consumer products division is teaming up with Jennifer Doudna’s CRISPR-focused outfit Mammoth Biosciences to develop a new COVID-19 diagnostic that would be fast, hand-held and fully disposable. | | 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. | 