Today's Rundown Gilead, Galapagos’ filgotinib aces first phase 3, suggesting it can compete with AbbVie’s upadacitinib Bristol-Myers Squibb begins phase 3 enrollment after psoriasis drug shows high skin clearance Atreca bags $125M as solid tumor trial comes into view Vital Therapies falls 88%, ditches liver treatment after phase 3 fail Coda Biotherapeutics launches with $19M to build ‘tunable’ gene therapy Featured Story | | | Wednesday, September 12, 2018 A phase 3 trial of Gilead and Galapagos’ JAK1 inhibitor filgotinib in rheumatoid arthritis has met its primary endpoint. The data suggest filgotinib is safe and as effective as JAK rivals including AbbVie’s upadacitinib, setting the stage for a four-way commercial scrap. |
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| This week's sponsor is Synteract, Inc. | | | |
Top Stories Wednesday, September 12, 2018 An oral tyrosine kinase 2 inhibitor from Bristol-Myers Squibb has checked off a phase 2 trial in plaque psoriasis, achieving high levels of skin clearance after three months of daily treatment. The big biotech has begun enrolling patients in a phase 3 study and is planning to study the drug in a wide array of immune-mediated diseases. Wednesday, September 12, 2018 Atreca has raised $125 million to step up its R&D activities. The series C round comes as Atreca gears up to move its lead solid tumor drug into the clinic and boost the throughput of the industrialized discovery engine it has built up over the past seven years. Wednesday, September 12, 2018 Vital Therapies is abandoning its cell-based therapy for liver failure and “considering strategic options” after it did not improve overall survival—the primary endpoint—in a late-stage study. Wednesday, September 12, 2018 Coda Biotherapeutics' goal is to create a gene therapy that can be switched on and off, and dialed up and down, to overcome limitations in current technology and open up more diseases to gene therapy. Resources Sponsored by: Veeva A top 20 pharma and growing biotech re-engineer regulatory processes. Sponsored by: Sciformix Are automation, big data and artificial intelligence (AI) a key part of your company’s pharmacovigilance strategy? Read this whitepaper to know what they should be! Sponsored by: Biotech Primer The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry. Sponsored by: Patheon, part of Thermo Fisher Scientific When developing a parenteral, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. Sponsored by: Baxter Baxter BioPharma Solutions’ whitepaper offers a method to address the challenges of tech transfer for lyophilized products from lab-scale to commercial-scale. Sponsored by: Catalent In this case study, an unknown leachable species was detected by GC-MS analysis of an alkaline drug product (pH approximately 10.5) that was packaged in a novel self- contained plastic Blow Fill Seal (BFS) vial. Sponsored by: Blue Matter A whitepaper outlining the key commercial challenges facing rare disease products, and how biopharmaceutical companies can overcome them. Sponsored by: AWS and Tableau Inova is using the capabilities of Tableau on AWS to identify biomarkers for personalized treatment intended to improve health outcomes for children. Sponsored by: Catalent Catalent provides world class stability services to ease your critical path to success. Sponsored by: AWS and Reltio Reltio and IQVIA provide holistic data management solutions for traditional pharma, emerging biotech, and consumer health companies, on AWS. Presented by: AWS and Druva Life Sciences organizations are embracing cloud-based Master Data Management (MDM) to modernize the organization of critical data. Sponsored by: Health Strategies Group The window of market exclusivity continues to narrow dramatically in the global marketplace. Given this demanding environment, your global market access team faces increasing urgency to get the value proposition right at the time of launch. Drug Approval, Manufacturing Quality & Regulation 2018 | Online Drug Development Boot Camp® 2018 – Registration closes 30 October - Register Now! November 14-15, 2018 | Boston, MA | Registration closes on the 30 of October 2018 due to Pre-Boot Camp preparations. Register now and start preparing. 2018 Latin America Healthcare Compliance Certification Program September 24-27, 2018 | Sao Paulo, Brazil Drug Development Immersion September 26-27, 2018 | West Windsor, NJ FierceBiotech 3rd Drug Development Forum October 1–3, 2018 | Hilton Boston Logan Airport Hotel | Boston, MA Compliance Certification Program at Seton Hall Law October 8-11, 2018 | Newark, NJ BioImmersion: Biotech for the Non-Scientist October 16-18, 2018 | Chicago, IL Fierce Innovation Awards: Life Sciences Edition 2018 FierceBiotech Executive Summit: London October 30, 2018 | Royal Society of Medicine Understanding Commercialization Within Biopharma Nov 7-8, 2018 | Boston, MA Drug Development Boot Camp® 2018 – Register Now! November 14-15, 2018 | Boston, MA | Register now and start your pre-Boot Camp preparation Drug Development Immersion December 5-6, 2018 | San Diego, CA Understanding Drug Pricing and Reimbursement December 12, 2018 | Boston, MA | 