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Today's Rundown UPDATE: Eli Lilly kick-starts speedy FDA review for Alzheimer's hopeful donanemab—and a one-on-one test against Aduhelm Novartis dumps Rett gene therapy caught up in Zolgensma scandal in cull of pipeline prospects Flagship-founded Axcella to test midstage NASH drug in patients with long COVID in phase 2a trial Sponsored: New Wacker Biotech site in San Diego (CA) serves growing pDNA demand for cell & gene therapy Lilly, Pfizer stop development of osteoarthritis drug after FDA rejection, extending bleak run for NGF inhibitors Vertex signs another Mammoth-sized CRISPR deal with $650M in biobucks on the line Cambrian secures $100M series C for Roivant-like approach to biotech creation with goal to slow down human aging Eli Lilly, Bayer, Merck join Mozart's chorus to the tune of $55M, as it launches into allegro phase Guardant’s liquid biopsy detects 96% of early-stage colorectal cancer cases with a single blood draw: study Early CARES funding was unevenly distributed to academic, well-off hospitals, study says Is Sandoz spinoff finally here? Novartis gets the ball rolling with strategic review Featured Story | By Ben Adams The great Alzheimer's R&D resurgence continues as Eli Lilly nabs an accelerated FDA review for its mixed bag drug donanemab, while also plotting direct head-to-head tests against Biogen’s new and controversial therapy Aduhelm. read more |
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Top Stories By Nick Paul Taylor Novartis has scrapped work on its Rett syndrome gene therapy AVXS-201 after finding the data don’t support further development. The action follows Novartis’ decision to gather extra data on the candidate in response to data manipulation during development of Zolgensma. read more By Kyle LaHucik Axcella Therapeutics will test its midstage NASH drug in patients with long COVID, or the presence of symptoms in the months following COVID-19 diagnosis. By year's end, the company will start testing the treatment in about 40 patients who tested positive at least 12 weeks prior and has agreement on the phase 2a trial design with the U.K.'s regulatory body. 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 Nick Paul Taylor The NGF inhibitor class has claimed yet another victim. After seeing regulators on both sides of the Atlantic knock back filings for approval, Eli Lilly and Pfizer have stopped global clinical development of tanezumab. read more By Kyle LaHucik Vertex Pharmaceuticals continues lining up CRISPR gene editing partners, this time linking arms with Jennifer Doudna-founded Mammoth Biosciences for $41 million upfront and $650 million in potential biobucks. read more By Kyle LaHucik Cambrian Biopharma will use $100 million in new financing to bankroll at least three clinical trials within the next 18 months. The biotech has 14 assets in its pipeline from 12 different partners, through a distributed investing model akin to Roivant and Atai, that it thinks reduces risks associated with the typical asset-centric startups. read more By Kyle LaHucik Mozart Therapeutics is starting with Symphony No. 55, or $55 million in financing from some Big Pharma big wigs, including Eli Lilly, Bayer and Merck. The biotech hopes to use T cells to go after celiac disease, inflammatory bowel disease and other autoimmune and inflammatory conditions. read more By Andrea Park Guardant's Lunar-2 liquid biopsy test is designed to catch colorectal cancer in its earliest stages and requires only a standard blood draw, offering a less invasive and time-consuming alternative to the current standards for screening. read more By Dave Muoio A new RAND Corporation study suggests early relief funds generally reached hospitals fielding the most COVID-19 patients but in the process left critical access hospitals out to dry. read more By Angus Liu When Novartis unveiled a plan in 2018 to grant its Sandoz generics business more autonomy, industry watchers read spinoff. Now, a separation may be around the corner. 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 Learn how to develop and get regulatory approval for medical devices November 3-4, 2021 | Live & Online 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 Learn how therapeutics are successfully launched and commercialized December 1-2, 2021 | Live & Online Launch Readiness for Medical Affairs & Communications Teams December 1-2, 2021 | Boston, MA Virtual Clinical Trials Summit December 6-7, 2021 | Philadelphia, PA Virtual European Healthcare Compliance Certificate Program January 24-28, 2022 Fierce Biotech Forum 2022 | Virtual Event | 