Today's Rundown Genfit warns costs of failed NASH trial will drag deep into 2020 Roche taps Vividion in $135M protein degradation deal Rallybio scores $145M, unveils lead rare disease program Inflammatory disease biotech Applied Molecular Transport aims for $100M IPO Moderna taps $1.34B stock offering to bankroll its promising COVID-19 vaccine SQZ Biotech snags $65M to push cancer vaccine, break into infectious disease Pfizer, Adage bump up Amplyx's series C to top $90 million Featured Story | | | Tuesday, May 19, 2020 Genfit has warned work on its failed phase 3 nonalcoholic steatohepatitis trial may continue deep into 2020, leading it to continue paying for a program that may never deliver returns. |
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Top Stories Tuesday, May 19, 2020 When Vividion Therapeutics spun out of The Scripps Research Institute, it aimed to “dramatically expand” the roster of druggable proteins. Now, three years down the line, its efforts have yielded a “huge oilfield with tremendous potential,” its CEO says, so it’s tapping its second Big Pharma partner to exploit that potential. Tuesday, May 19, 2020 When a trio of Alexion veterans started Rallybio, they vowed to take an “agnostic” approach to new medicines, because “diseases have no boundaries, so why should we?” Two years later, they’ve raised $145 million to bankroll a pipeline of early-stage assets led by a treatment for a life-threatening condition that causes bleeding in infants. Tuesday, May 19, 2020 Just eight months after breaking cover, Applied Molecular Transport is gunning for a $100 million IPO to bring its lead program into phase 2 studies. It plans to test the oral IL-10 agonist as an add-on to anti-TNF therapies in ulcerative colitis and rheumatoid arthritis, as well as a single agent for ulcerative colitis and pouchitis. Tuesday, May 19, 2020 Money from the largest biotech IPO in history, funding from an international outbreak preparedness group and an award from the U.S. government are apparently still not enough for Moderna. The biotech's now looking to raise $1.34 billion through a public offering to manufacture its COVID-19 vaccine candidate. Monday, May 18, 2020 SQZ Biotech reeled in $65 million to propel its lead asset, a cancer vaccine for HPV-positive tumors, through phase 1 and expand its cell-squeezing technology beyond oncology into infectious diseases. The company’s pipeline is based on a cell therapy platform that squeezes cells, disrupting their membranes to get materials into them. Tuesday, May 19, 2020 Eight months after picking up an antibody program from Novartis, Amplyx Pharmaceuticals topped up its coffers to push it through phase 2. Pfizer and Adage Capital Management got in its series C extension, bringing the round’s total to $93 million. | | 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. | 