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Tuesday, December 6, 2022 | 12pm ET/9am PT Biopharma customers are now demanding that the vendor industry work collaboratively to connect their scientific workflows. This webinar will provide valuable insights for biopharmaceutical scientists, lab directors, IT professionals, and life science vendors. Register now. 
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Today's Big NewsDec 1, 2022 |
| By Gabrielle Masson Eli Lilly CEO David Ricks was confident last year that donanemab would best Biogen’s Aduhelm in a head-to-head battle. Now, the results are in—and Ricks was right. |
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By Nick Paul Taylor Pfizer and Valneva have added another plank of evidence in support of their Lyme disease vaccine candidate, revealing that antibody levels remained elevated six months after the completion of dosing in a phase 2 clinical trial. |
By Gabrielle Masson Biotech’s layoff sinkhole keeps growing, this time pulling in SQZ Biotechnologies and Synlogic, two Massachusetts companies that have also dropped pipeline programs to stay afloat. |
Sponsored by Slope Slope is revolutionizing the different levels of clinical trials through an all-in-one collaborative tool. Learn how Slope’s eClinical Supply Chain Management platform provides robust technology to the clinical trial space, covering all areas of supply management without losing sight of the chain of custody. |
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Tuesday, December 7th, 2022 | 10am ET/7am PT In this presentation we’ll review how we established GOCHO™ cells from an adherent CHO-K1 cell line to meet current industry standards, how the choice of cloning media drove cell culture media choices for the entire cell-line development process, and more. Register now. 
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By Annalee Armstrong Prolific biotech maker Roivant and Pfizer have partnered to launch a new inflammatory- and fibrotic-diseases-focused company. We checked, and Roivant is not ready to publicly name the new venture, but we at Fierce have a suggestion that rolls off the tongue: Pfvant. |
Sponsored by Unlearn As leaders of clinical drug development, we owe it to trial patients to continuously innovate randomized control trial (RCT) designs that help to assuage fears of placebo by reducing the number of patients required to be enrolled in a control group — and to run faster trials that get answers sooner. |
By Annalee Armstrong SPAC deals are creeping back into the mainstream, with Liminatus Pharma and Iris Acquisition Corp. becoming the latest in the biotech sphere to test the waters. |
Sponsored by Ocugen Nuclear hormone receptors are master regulators of multiple molecular pathways. When used as a modifier gene therapy they could reverse the pathological phenotypes of multiple inherited retinal dystrophies (IRDs). |
By Nick Paul Taylor Rallybio has become the latest company to hitch its antibody drug development efforts to AbCellera. The partners will co-develop up to five rare disease therapeutic targets in a risk-sharing pact, starting with a metabolic disease program. |
By Kevin Dunleavy The FDA has signed off on Ferring Pharmaceuticals' Rebyota, a one-time, enema-delivered therapy for Clostridium difficile that can restore proper bacterial balance in the digestive system. As the first FDA-approved fecal microbiotica product, Rebyota represents a significant milestone, potentially clearing the way for other such treatments. |
By Joseph Keenan CRO startup Vial, which focuses on offering clinical trial services to the biotech industry, reeled in $67 million in series B funding it plans to use to further its global expansion. |
By Robert King A new bill seeks to reform CMS' Medicare coverage determination process in response to criticism of the agency's decision earlier this year to only narrowly cover the drug Aduhelm. |
By Joseph Keenan Advanced Clinical has tapped Ravi Karra, M.D., to be vice president of the CRO’s oncology unit. |
By Andrea Park “What we've shown is a chest X-ray is more than a chest X-ray,” said Jakob Weiss, M.D., lead author of the study . |
By Joseph Keenan Trialbee, a privately held patient enrollment company, has sweetened its clinical trial offering with the rollout of Honey Omnichannel that tracks multiple recruitment sources. |
Fierce podcasts Don't miss an episode |
| This week on “The Top Line,” we share this week's headlines and discuss the 2022 honorees in our annual Fiercest Women in Life Sciences report. |
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Thursday, December 8, 2022 | 11am ET/8am PT Frontage Laboratories will dive into their Quantitative Whole Body Autoradiography (QWBA) services. They will look at Radiation Dosimetry reports that support human Absorption, Metabolism, and Excretion (hAME) studies at one of their clinical sites. Register now. 
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Video Revolutionize your monoclonal antibody (mAb) manufacturing process with the Gibco™️ Efficient-Pro™️ Medium and Feed System. Watch our how-to video. Sponsored by: Thermo Fisher Scientific |
Whitepaper Learn how to develop a high-performing supply chain for GMP-manufactured chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific. Sponsored by: Thermo Fisher Scientific |
Whitepaper Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation. Sponsored by: Thermo Scientific Production Chemicals and Services |
Webinar Twist Bioscience CSO Dr. Aaron Sato shares how Twist's tools for antibody discovery have been applied to identify antibodies against diverse and challenging targets. See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Presented by: Twist Bioscience |
Whitepaper This paper outlines how gene therapy supply chains are different from traditional biopharma products, as well as the factors that are essential to success. Sponsored by: Blue Matter |
Executive Summary Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more. Sponsored by: Catalent |
Whitepaper How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
Whitepaper Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more. Sponsored by: Catalent |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
Whitepaper Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Biologics |
Whitepaper Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
Whitepaper Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
Research Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
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