Featured Story | By Nick Paul Taylor A phase 3 clinical trial of Humanigen’s lenzilumab in hospitalized COVID-19 patients has met its primary endpoint. Humanigen plans to use the data to seek emergency use authorization from the FDA. read more |
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Top Stories By Nick Paul Taylor An independent investigation has found uniQure’s hemophilia B gene therapy is “highly unlikely” to have caused the liver cancer developed by a recipient of the investigational candidate. read more By Amirah Al Idrus People with hereditary angioedema suffer recurrent attacks, including swelling of the airways or intestinal tract that can be life-threatening. Ionis Therapeutics’ antisense treatment beat placebo at curbing those attacks in a phase 2 study, reducing the number of attacks patients experienced per month by an average of 90%, top-line data show. read more Sponsored By: GT Biopharma, Inc. Promising clinical efficacy and strong safety results open the door to an economic, off-the-shelf cancer therapeutic, without need of outside supplemental engineered NK cells or any combination drugs. read more By Ben Adams Orphazyme saw its stock sink more than 30% in Europe Monday morning after it failed to to hit any of the endpoints in a phase 2/3 trial. read more In Partnership With: AmerisourceBergen As light begins to shine at the end of the pandemic tunnel, drug manufacturers and healthcare systems are looking at the best ways to maintain the digital momentum spurred by the crisis to provide support to patients and overcome any barriers the transition to a post COVID-19 world may reveal. read more By Amirah Al Idrus Cancer drugs stop working when malignant cells develop molecular changes that allow them to evade the drugs’ effects. But what if, instead of switching patients to medicines as their cancer becomes resistant, doctors could instead combine multiple drugs into one treatment, such as a pill, that would head off any and all resistance mechanisms a cancer might develop? read more By Conor Hale Amazon has received authorization from the FDA for its very own COVID-19 test as part of its employee screening program. read more By Arlene Weintraub Researchers at Lehigh University discovered a previously unknown interaction between sugars, or glycans, on the surface of ACE2 receptors and SARS-CoV-2’s spike protein. It may explain why COVID-19 has a higher infection rate than the outbreak caused by SARS-CoV-1 two decades ago, they said. read more By Eric Sagonowsky Perhaps more than any other industry, the biopharma industry was front and center during the coronavirus pandemic that caught the world off guard in 2020. Here, Fierce Pharma ranks the top 20 drugmakers by global revenues in 2020. read more Resources Sponsored By: OCT Clinical Find out why more than 400 clinical trials annually are initiated in Russia by US and EU pharma in the free annual report by OCT Clinical. Sponsored by: PulsePoint Access this guide for the latest insights into how marketers can use data, technology, and personalized messaging to build vaccine confidence and drive successful immunization efforts. Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: TAC Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: Almac Clinical Technologies This industry report reveals qualitative and quantitative candid insight from clinical development insiders and their views on current clinical trial challenges faced amidst uncertainty. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored By: AmerisourceBergen Corporation Unlock product potential by making the most of your commercialization investments. Sponsored By: Culture Biosciences Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly. Sponsored By: Acorn AI Unlock competitive advantage with AI and advanced analytics. Sponsored By: EVERSANA Mature brands lost billions in revenue and value during COVID, but with the right strategy, pharma can rebound and reignite revenue. Learn How. Sponsored By: BC Platforms Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. Sponsored By: Thermo Fisher Scientific Involved in vaccine development? Check out this timely infographic detailing the history of vaccines, key development milestones, and what challenges remain. Sponsored By: Blue Matter, strategic consultants in the life sciences A look ahead at how cell-based therapies in oncology will advance during 2021-22: research, regulatory, and commercial milestones. Sponsored by: Baxter BioPharma Solutions While service directories are filled with CMOs claiming vaccine fill-finish experience, the logistical challenges resulting from seasonal product are unique and it is important that outsourcing partners can ensure quality and on-time delivery. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. 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. | 
