| Editor's note: FierceBiotech will not publish Monday in observance of Memorial Day, but we’ll be back in your inbox Tuesday, May 26.; Today's Rundown AstraZeneca's COVID-19 vaccine enters phase 2/3 clinical trial Genentech posts long-term data on near-approval Soliris rival Inovio CEO on the COVID-19 vaccine race: Don’t count us out Syndax cans FDA filing for lead cancer med after breast cancer bust This cancer-related gene may also hold the key to beating obesity FDA names 28 antibody tests to be taken off the market NASH front-runner Intercept, already delayed twice, faces another FDA setback FiercePharmaAsia—CanSino's mRNA coronavirus vaccine; WuXi's buildup; Fujifilm's Avigan failure? Chutes & Ladders—Warp Speed's Slaoui sells $12M in Moderna stock Featured Story | | | Friday, May 22, 2020 Researchers at the University of Oxford have begun enrolling subjects in a phase 2/3 clinical trial of AstraZeneca-partnered COVID-19 vaccine AZD1222. The next stage of the program, which follows a 1,000-subject phase 1, is set to enroll 10,260 people in the U.K. to generate results to support the first shipments to customers in September. |
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Top Stories Friday, May 22, 2020 Genentech has shared longer-term phase 3 safety data on its anti-IL-6 antibody satralizumab, adding to the evidence in support of the drug ahead of a FDA decision to approve it in a rare disease served by Alexion’s Soliris. Friday, May 22, 2020 As Inovio works to advance its DNA vaccine to fight COVID-19 into late-stage trials, it has been targeted by short sellers, or simply overlooked as bigger and better-funded rivals rapidly move forward with competing candidates. But Inovio CEO J. Joseph Kim remains confident that his company's long effort to develop DNA vaccines will pay off. Friday, May 22, 2020 Syndax’s lead cancer drug failed a phase 3 study in metastatic breast cancer, leading the company to abandon an FDA filing in that indication. The phase 3 study found that adding entinostat to hormone therapy did not help patients with HR-positive, HER2-negative breast cancer live longer compared to the hormone therapy alone. Friday, May 22, 2020 Some people can eat whatever they want and never seem to gain weight. An international team of scientists found that variants in the ALK gene, most closely linked to cancer, can make these individuals resistant to weight gain, suggesting blocking the gene might help fight obesity. Friday, May 22, 2020 The FDA named more than two dozen coronavirus antibody diagnostics that should be taken off the market weeks after the agency closed its open-door policy on COVID-19 blood tests and required developers to submit their products and data for review. Friday, May 22, 2020 Intercept Pharmaceuticals, eager to market its potential nonalcoholic steatohepatitis medicine obeticholic acid, will have to keep waiting. After two prior delays at the FDA, the company on Friday disclosed another. Friday, May 22, 2020 China's CanSino, currently leading the COVID-19 vaccine race, has paired with Precision NanoSystems to work on an mRNA shot. WuXi Biologics finalized a deal to build a $60 million facility in the Boston area. Fujifilm's Avigan reportedly failed in mild and asymptomatic coronavirus patients. And more. Friday, May 22, 2020 Slaoui said he plans to sell about 155,000 Moderna shares, holdings which grew in value by about $2.4 million after the vaccine developer announced early positive data this week. Meanwhile, Gossamer Bio's CMO jumps to Atara, while Pandion recruits a Gilead alum as CMO. | | 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. |
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: 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. | 