Today's Rundown FDA hits Zafgen’s beloranib successor with clinical hold After gene therapy pivot, Axovant bolsters its executive ranks Vir starts trial of RNAi drug for hep B seeking functional cure [Sponsored] Minimal Residual Disease: Application in Blood Cancers Vectura cans VR475 after it fails phase 3 asthma test Illumina leads €16M round for digital PCR firm Stilla Technologies Featured Story | Monday, November 26, 2018 The FDA has placed a clinical hold on Zafgen’s ZGN-1061. Zafgen suffered the blow after failing to allay the FDA’s concerns that ZGN-1061 will face similar cardiovascular safety problems to its predecessor, beloranib. |
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| Top Stories Monday, November 26, 2018 After switching its focus midyear from Alzheimer’s disease to gene therapy, Axovant is appointing a slew of new executives, including a pair of Novartis alums and several biotech veterans, to posts ranging from clinical development to commercial operations. Monday, November 26, 2018 Vir Biotechnology has started a phase 1/2 trial of its gene-silencing drug for hepatitis B virus, the first clinical candidate from its partnership with Alnylam Pharmaceuticals. Monday, November 26, 2018 A diagnosis of chronic lymphocytic leukemia (CLL) can mean a long road with many twists and turns as patients try to achieve long-term remission from this chronic, complex and progressive form of blood cancer. Monday, November 26, 2018 A phase 3 trial of Vectura’s VR475 in patients with severe uncontrolled asthma has missed its primary endpoint. The blow prompted Vectura to halt work on the nebulized formulation of the budesonide. Monday, November 26, 2018 Illumina’s venture arm led a €16 million ($18 million) series A round for Stilla Technologies, a Paris-based developer of digital PCR solutions for genetic analysis. This week's sponsor is Johnson & Johnson Innovation. | | | Enrollment Showcase | Sponsored by: Biotech Primer BioBasics is an intensive two-day course starting with a review of the healthcare sectors and the scientific concepts required for understanding the biopharma industry, then delves into the cause of genetic and infectious disease, diagnostics and strategies used to mitigate disease and finally the latest innovations in biopharma are explained. Register today! |
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| Resources Sponsored by: Coupa Software Learn how Becton Dickinson implemented Coupa to create an easy-to-use purchase to pay process that increased efficiency across the organization. Sponsored by: Almac Diagnostic Services, part of the Almac Group Download the whitepaper to learn more. Sponsored by: Reprints Desk, Inc. Learn how to fast-track your research workflows! Sponsored by: Veeva Industry Research: Read the 2018 Unified Clinical Operations Report to find out how pharmas and CROs are evolving clinical trial processes. Sponsored by: Applied BioMath This on-demand webinar introduces a quantitative systems pharmacology (QSP) model of targeted anabolic growth factors for intra-articular injection for the treatment of diseased joints. Sponsored by: Oracle Health Sciences New research reveals more than 50% of clinical data management professionals surveyed, are not confident in the quality and completeness of their clinical trial data. Sponsored by: Veradigm New Case Study – Leveraging Real-World Evidence From EHR to Assess Migraine Management Sponsored by: Signals Analytics What does data tell us about the future of cell & gene therapy? Sponsored by: Patheon, part of Thermo Fisher Scientific Download the whitepaper to learn more. Sponsored by: Outer Edge Technology Outer Edge Technology specializes in designing and managing regulated cloud-based infrastructures for the Life Sciences Industry – typically leveraging the AWS and Microsoft Azure platforms. Sponsored by: Catalent In the United States, it takes an average of 12 years for an experimental drug to travel from the laboratory to a patient’s medicine cabinet. The average cost to research and develop a successful drug is approximately $2.6 billion. Sponsored by: Catalent Today’s scientists are under significant time pressure to accelerate their compound from discovery to the clinic. Such pressure can often lead research organizations to adopt short-term thinking and overlook the downstream realities of drug development. Sponsored by: Catalent What is the fastest way to success? It is critical that drug developers execute several elements related to planning, investment, and understanding of the risks, risk tolerance, and pitfalls inherent in the drug development program. 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: Catalent Develop a basic understanding of principles and concepts of bioavailability of oral drugs. Drug Approval, Manufacturing Quality & Regulation 2018 | Online Compliance Training for Professionals working in APAC region March 4-7, 2019 | Singapore FierceBiotech Executive Breakfast at the J.P. Morgan Healthcare Conference 2019 January 8, 2019 | The Fairmont Hotel | San Francisco, CA BioBasics: Biotech For The Non-Scientist December 5-6, 2018 | Boston, MA Phacilitate Leaders World 2019 January 22-25, 2019 I Hyatt Regency, Miami Molecular Medicine Tri-Conference March 10-15, 2019 | San Francisco, CA |