| | 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. |
EMA starts rolling review of Merck's molnupiravir, continuing rapid regulatory response to COVID-19 antiviral data Erytech shifts focus to leukemia as lead drug flunks late-stage pancreatic cancer trial AstraZeneca veteran takes up CEO post at Medivir, becoming 4th person to hold the post in quick succession Sponsored: New Wacker Biotech site in San Diego (CA) serves growing pDNA demand for cell & gene therapy Gilead's Immunomedics CMO jumps to Aadi as the biotech eagerly awaits FDA decision for first drug Cedilla tops off series B with additional $25M to test drugs in mesothelioma, certain breast cancers Juventas Cell Therapy closes a $63M funding round as it eyes a big push for blood cancer hopeful Intellia, LogicBio fuel hope for in vivo gene editing with new animal data in rare diseases: report Alexa is finding a voice in healthcare. Cedars-Sinai, Boston Children's sign on for new Amazon smart hospital service With Sanofi still on board, Click Therapeutics closes $52M series B for digital therapeutics in depression, chronic pain and more Top 10 drug launch disasters Featured Story | By Nick Paul Taylor Merck has opened another front in its campaign to get molnupiravir to market, kicking off a process that could lead to the approval of the oral COVID-19 antiviral in the European Union. read more |
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Top Stories By Annalee Armstrong After seeing an overall survival benefit in a mid-stage study of eryaspase in pancreatic cancer, Erytech Pharma likely thought a phase 3 would be in the bag. But the results are out and the phase 3 trial did not confirm the earlier result. read more By Nick Paul Taylor And the next person to hold the CEO post at Medivir is … Jens Lindberg. The AstraZeneca veteran will become the fourth person to hold the post, on an interim or permanent basis, in quick succession when he takes up the position. 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 She got Trodelvy to the finish line and now Loretta Itri, M.D., hopes to get Aadi Bioscience's first drug to market. The Immunomedics chief medical officer is leaving the Gilead-owned company to take up the same post at Aadi. read more By Kyle LaHucik Cedilla Therapeutics added $25 million to its 2020 series B to bring two lead programs into the clinic next year. One goes after mesothelioma and certain squamous cell carcinomas, and the other targets certain cancers such as breast, esophageal, stomach, ovarian and uterine. read more By Ben Adams Juventas has grabbed a $63 million series C to advance its CASI Pharmaceuticals-partnered drug CNCT19. read more By Arlene Weintraub Jefferies analysts examined new animal data that in vivo gene editing players Intellia and LogicBio presented at the European Society of Gene and Cell Therapy (ESGCT) conference and concluded that investors are still underestimating the potential of the emerging technology, which is designed to be injected directly into patients to correct inherited diseases. read more By Heather Landi Amazon launched a new service for hospitals that will embed its voice technology deeper into clinical settings at scale. As part of Alexa Smart Properties, the service will simplify how hospitals deploy and manage Alexa-enabled devices. An Amazon executive said the new service is just the tip of the iceberg for using ambient technology in healthcare. read more By Andrea Park With its third multimillion-dollar influx of funding in barely a year, another medtech developer’s plans to create digital therapeutics to treat a wide range of illnesses are clicking into place. read more By Angus Liu An estimated 40% of drugs approved between 2004 and 2016 underperformed, according to Wall Street’s prelaunch sales forecasts. That's a lousy track record, given that a strong launch is critical to a drug's success. Here, we list 10 drug launches from the past five years that suffered the most noteworthy failures. 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 | 