Today's Rundown Gilead/Galapagos, Intercept and Corbus trials could be hit by coronavirus spread: analyst J&J partner Legend plans IPO to fund CAR-T pipeline MedDay's multiple sclerosis drug a bust in phase 3 Cell Medica rebrands as Kuur, raises cash for CAR-NKT trials Silverback Therapeutics bags $79M to push antibody-drug conjugate into clinic BARDA backs development of Hologic's high-throughput coronavirus test Featured Story | | | Wednesday, March 11, 2020 Analysts at RBC are warning that a host of biopharmas could see their ongoing phase 3 trials hit by the novel coronavirus, as early-stage trials are particularly under threat. |
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Top Stories Tuesday, March 10, 2020 Legend Biotech has filed for an IPO. The Chinese CAR-T player plans to list its stock in the U.S. to fund the advance of a pipeline spearheaded by Johnson & Johnson-partnered anti-BCMA JNJ-4528. Tuesday, March 10, 2020 Four years ago, MedDay Pharmaceuticals’ multiple sclerosis drug reversed the course of disease in 150-patient pivotal study. The biotech set out to confirm those results in a much bigger phase 3 study but it fell short, missing its endpoints in a study of more than 600 patients with non-active progressive MS. Wednesday, March 11, 2020 Cell Medica has rebranded as Kuur Therapeutics, pulling in fresh funds from IP Group, Baylor College of Medicine and Schroder Adveq along the way. Kuur will use the money to fund phase 1 trials of autologous and allogeneic CAR natural killer T cell therapies. Wednesday, March 11, 2020 Silverback Therapeutics is working on a new kind of antibody-drug conjugate: one that targets the immune response to cancer rather than attacking tumor cells themselves. And it’s just raised $78.5 million to bankroll its pipeline. Its work is based on technology that attaches antibodies to small molecules that adjust the immune system instead of cell-killing agents. Wednesday, March 11, 2020 The U.S. Department of Health and Human Services is backing the development of Hologic’s high-throughput coronavirus diagnostic, which it says will be able to process up to 1,000 samples per day and deliver results in under three hours. | | Experts in our field; with 20+ years’ experience in Viral Vector & plasmid DNA (R&D, High Quality and GMP) manufacture for pre-clinical, clinical & commercial supply. Take a virtual tour of our facilities & find out more about our expansion project. |
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Resources 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: 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 about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. 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Sponsored by: Clinical Ink Download this free white paper to learn how a BYOD ePRO approach is beneficial to your trial. Sponsored by: Catalent This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. Sponsored by: Accenture Kevin Julian, senior managing director of Accenture’s life sciences practice, recently sat down with FierceBiotech to discuss market trends and Accenture’s new technology platform, INTIENT. Sponsored by: Blue Matter Consulting White paper describing how a biopharma company can successfully differentiate an oncology product when the clinical profile alone is not enough to get the job done. Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. Sponsored by: Catalent Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric. Sponsored by: Altran This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future. Sponsored by: Catalent Pharma Solutions In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey. Bioprocessing Summit Europe – Practical Solutions for Today’s Bioprocess Challenges March 24-26 2020 | Barcelona, Spain BioBasics 101: The Biology of Biotech March 26-27, 2020 | Boston, MA Clinical Trial Innovation Summit – Technology, Data, Operations, Oversight April 6-8, 2020 | Cambridge, MA Drug Discovery Chemistry – Choose from 45 Presentations from Top Pharma April 13-17, 2020 | San Diego, CA Medical Affairs Strategic Summit (MASS) East April 14-16, 2020 | New Brunswick, NJ BioBasics 101: The Biology of Biotech April 16-17, 2020 | Philadelphia, PA Drug Development Immersion April 23-24, 2020 | Boston, MA 2nd Annual World Pharma Week: Driving Innovation in Drug R&D June 2-4, 2020 | Boston, MA European Healthcare Compliance Certificate Program June 2-5, 2020 | Paris, France BIO International Convention June 8-11, 2020 | San Diego, CA U.S. Healthcare Compliance Certificate Program June 8-10, 2020 | Newark, NJ Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. | 