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| How is the Microbiome Influencing your Immune-Oncology Program? The gut microbiota is a complex ecosystem of microorganisms that have been found to play a significant role in the response to cancer therapy and susceptibility to toxic side effects of those drugs. Understand how the microbiome may affect patients’ health and impact on your preclinical development path with this educational white paper. Learn more. |
Today's Rundown Featured Story | By Annalee Armstrong A cadre of big and small biotechs and pharmas plus nonprofit organizations have signed on to a new U.S. federal government initiative to go after gene therapies for rare diseases. read more |
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Top Stories By Ben Adams Sanofi, in its third-quarter financials posted early Thursday morning, outlined a list of delays for a number of key assets as it dropped a biotech-partnered drug. read more By Kyle LaHucik The addition of Merck's new oral pill to a cocktail of approved medicines for HIV-1 produced a viral response comparable to common treatments including antiretroviral therapies in two phase 3 trials, moving the pharma closer to a regulatory filing for a new way to treat the stubborn virus. 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 Kyle LaHucik Checkmate Pharmaceuticals President and CEO Barry Labinger is out the door at the clinical-stage cancer biotech without an explanation, and financial operations veteran Alan Fuhrman will take on his duties in an interim role. read more By Nick Paul Taylor Frazier Healthcare Partners is expanding its investment activity, raising $830 million for its first fund dedicated to public life science companies. The targets? Small and mid-cap biotechs that are off the beaten path or recovering from a value-crushing setback. read more By Kyle LaHucik Takeda will buy its gamma-delta T-cell therapy partner GammaDelta Therapeutics after the U.K. biotech began its first clinical trial just last month. The two companies initially came together in 2017 under a $100 million R&D agreement. read more By Nick Paul Taylor Rafael Pharmaceuticals' bet on the rock-hard pancreatic cancer indication has blown up in its face. The pivotal trial found devimistat had no effect on overall survival—and, as a kicker, another phase 3 in a blood cancer was stopped early for futility. read more By Angus Liu A research team from MD Anderson Cancer Center has found a genetic signature that could not only help doctors select the the patients most likely to respond to immuno-oncology drugs, but that could also open the door to sensitizing other patients to immunotherapy. The genetic signature signals deficiencies in a cellular process called the "replication stress response." read more By Conor Hale The 10 principles aim to underline what the agencies describe as “Good Machine Learning Practice” in the same vein as the industry quality standards centered around product manufacturing or clinical testing. read more By Eric Sagonowsky Shortly after Sanofi CEO Paul Hudson joined the company in 2019, he laid out an ambition to invest as much as necessary to turn the Regeneron-partnered antibody drug Dupixent into a megablockbuster. Two years later, Sanofi is well on its way. read more By Robert King Optum's HouseCalls program, which aims to improve care coordination for Medicare Advantage beneficiaries, had to quickly pivot from house calls to telehealth visits in less than two weeks. 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 | 
