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GSK, after pushing past midphase fail, ends development of otilimab in COVID-19 Novavax completes UK filing for COVID-19 vaccine but pushes FDA ask till end of year Cortexyme will forge ahead with failed Alzheimer's drug—just like everyone else Sponsored: New Wacker Biotech site in San Diego (CA) serves growing pDNA demand for cell & gene therapy After COVID flop, Angion's leading med fails again, this time in kidney transplant patients as shares halved Takeda-backed cardiovascular biotech Cardurion nabs $300M investment from Bain Capital ElevateBio cuts a deal for Life Edit, adding genome engineering tech to support gene therapy pipeline Merck marks a first with global health org to license its COVID-19 pill Duke and UC scientists find a potential remedy for chronic pain from a 'junkyard of cancer drugs' Inclusion of women in stroke trials hasn't changed in 30 years: study One Drop launches Bayer-boosted AI program for preventing heart disease Most healthcare executives don't trust their organization's data, survey finds Medable adds $304M to treasure chest with fourth raise in 18 months for virtual trials Featured Story | By Nick Paul Taylor GlaxoSmithKline is stopping development of otilimab in COVID-19, reacting to the failure of the drug in phase 2 and the progress of its anti-SARS-CoV-2 antibody by pulling the plug on the program. Development of otilimab in rheumatoid arthritis is continuing. read more |
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Top Stories By Kyle LaHucik The FDA is no longer Novavax's first choice. The Maryland biotech has instead completed submission of its protein-based COVID-19 vaccine to the U.K.'s regulator and will wait a bit longer before asking the FDA for clearance. read more By Annalee Armstrong In what is now a very familiar pattern, Cortexyme’s Alzheimer’s disease treatment has failed to improve cognitive function in a phase 2/3 clinical trial, but no matter. Executives say they’ll move forward with it anyway. read more Sponsored by: Wacker Biotech Plasmid DNA Manufacturing: New Wacker Biotech site in San Diego (CA) serves growing pDNA demand for cell & gene therapy. Learn more about our plug & play platform. read more By Ben Adams Angion Biomedica saw its shares down more than 50% early Wednesday morning on news that its kidney transplant hopeful ANG-3777 has failed a key phase 3 test. read more By Annalee Armstrong Takeda-backed cardiovascular disease specialist Cardurion Pharma has a new investor and $300 million in cash to play with after Bain Capital joined the supporting cast. read more By Nick Paul Taylor ElevateBio has enjoyed a close look at Life Edit Therapeutics over the past 11 months, with overlaps in the management team and involvement in its portfolio of cell and gene therapy companies giving it a chance to see how the genome editing specialist ticks. The experience has persuaded ElevateBio to buy the business. read more By Joseph Keenan Merck took a big step in combatting the global pandemic by inking a deal of firsts for the Medicines Patent Pool that allows the health organization to sub-license versions of molnupiravir and supply the COVID-19 oral medication to 105 low and middle-income countries. read more By Arlene Weintraub Researchers from Duke and the University of California at Irvine screened a library of more than 1,000 compounds and discovered that an old, experimental cancer drug called kenpaullone enhances the expression of the gene KCC2, which is essential for silencing pain signals. The drug was effective in treating mouse models of pain from nerve injury and bone cancer, they reported. read more By Kyle LaHucik The average prevalence of stroke in women is about 48%, whereas about 37.4% of the nearly 589,000 patients in clinical trials between 1990 and 2020 were women, according to a new study. read more By Conor Hale The digital diabetes maven One Drop is taking new steps into the broader healthcare world with an artificial intelligence-powered platform aimed at preventing cardiovascular disease, co-developed with the pharmaceutical giant Bayer. read more By Anastassia Gliadkovskaya Most agree good data are key to informed decisions, but few fully trust their organization's data or consider its capabilities highly developed. read more By Kyle LaHucik Medable had already raised more than $200 million since the pandemic's start but it's more than doubling that treasure trove with another $304 million to eke out competitors in the burgeoning virtual trials space. Large private equity backers joined the round. read more Resources Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Sponsored by: Medable, Inc. Find out how to improve clinical protocol adherence, and thus patient outcomes, by 15%+ with Medable’s latest White Paper. Sponsored By: Trial Interactive Check out the eTMF Implementation Quick Guide to see a checklist TMF experts developed to help you reduce risks, maintain compliance, and establish effective processes in your eTMF. Sponsored By: Bioclinica This whitepaper addresses where AI can make the biggest impact in clinical trials. Sponsored by: Thermo Fisher Scientific Looking to accelerate your biotech company, but not sure where to start? Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. Sponsored by: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: LabVantage Solutions Shift from data collection to data science. Add advanced analytics to your lab informatics platform to yield valuable, action-ready insights from LIMS and other data. Sponsored by: Thermo Fisher Scientific Integrate supply chain simulation into your early clinical trial planning to minimize risk in an uncertain supply chain environment, improve supply chain outcomes, and help streamline time-to-market for innovative therapies. Sponsored by: WCG Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Fierce Health Payer Summit October 26, 2021 | Virtual Event Pharma Meeting Pros Summit November 3-4, 2021 | Atlantic City, NJ & Virtual Diversity, Equity & Inclusion Summit November 9–10, 2021 | Virtual Event Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Learn impact of pricing, competitive assessment, epidemiology November 17-18, 2021 | Live & Online New Product Planning Summit December 1-2, 2021 | Boston, MA Launch Readiness for Medical Affairs & Communications Teams December 1-2, 2021 | Boston, MA Learn how therapeutics are successfully launched and commercialized December 1-2, 2021 | Live & Online Virtual Clinical Trials Summit December 6-7, 2021 | Philadelphia, PA Fierce JPM Week January 11, 2022 | San Francisco, CA & January 18-20, 2022 | Virtual Event Virtual European Healthcare Compliance Certificate Program January 24-28, 2022 Fierce Pharma Drug Safety Summit February 2022 | Location TBD Fierce Biotech Forum 2022 | Virtual Event | 