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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 2, 2022 |
| By Nick Paul Taylor Mirati Therapeutics is going to have to wait a bit longer to learn if sitravatinib works. Having touted an interim phase 3 review as an event that could support full approval, the biotech has learned that the lung cancer study will continue to its final analysis. |
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By Nick Paul Taylor The FDA has killed off Y-mAbs Therapeutics’ slim hopes of winning approval for 131I-omburtamab at the first time of asking. Weeks after its advisory committee roundly rejected the candidate, the agency has hit YmAbs with a complete response letter and discussed the need for an adequate and well-controlled trial of the rare pediatric cancer drug. |
By James Waldron Four months after the FDA slapped a clinical hold on Beam Therapeutics’ phase 1 ready off-the-shelf CAR-T, the biotech is now free to proceed. |
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 James Waldron Theratechnologies has pumped the brakes on a phase 1 trial of its lead cancer asset after a glimpse at the data raised efficacy concerns. |
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 Roche’s Genentech unit is walking away from a clutch of studies for its leading Alzheimer’s therapy gantenerumab, weeks after the monoclonal antibody failed a pair of phase 3 studies. |
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 Gabrielle Masson Vaxxinity’s next-gen COVID-19 booster candidate has hit its safety targets in a head-to-head trial against Pfizer-BioNTech’s, AstraZeneca’s and Sinopharm’s vaccines. The biotech plans to push ahead for approval in several countries, despite mixed efficacy results against its competitors. |
By Gabrielle Masson,Andrea Park After only a few weeks of searching for a new CEO, generics mammoth Teva Pharmaceuticals has ended its mission to replace current top exec Kåre Schultz. |
By Angus Liu Eisai's detailed lecanemab data in Alzheimer's disease were clouded by safety questions. BeiGene's Brukinsa hands down an all-around win against AbbVie and Johnson & Johnson's Imbruvica in a head-to-head trial. Shionogi has finally snagged the first approval for its oral COVID-19 drug, now called Xocova. And more. |
By Fraiser Kansteiner In a late November court decision unsealed Wednesday, the U.S. Court of Federal Claims sided with Gilead’s argument that the U.S. Centers for Disease Control and Prevention broke certain agreements with the company around its HIV drug for preexposure prophylaxis. The win could bode well for a separate patent case where the U.S. government is seeking more than $1 billion in damages from Gilead. |
By Robert King The Senate Finance Committee released a discussion draft outlining new ways to improve mental health pay parity as part of a larger package. |
By Ben Adams ViiV Healthcare has found that global stigma attached to HIV patients remains woefully strong in a new survey. |
Fierce podcastsDon't miss an episode |
| | This week on “The Top Line,” we discuss the current state of Biogen and recent investor reactions to the new hire. Plus we cover the week's news including: What Albert Bourla said that has him in hot water, a $3.5 million drug, and we tease a possible major acquisition. |
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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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| VideoRevolutionize your monoclonal antibody (mAb) manufacturing with expert insights. Sponsored by: Gibco |
| WhitepaperLearn 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 |
| WhitepaperPreparation 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 |
| WhitepaperThis 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 |
| WhitepaperHow 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 |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
| WhitepaperLearn 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 |
| WhitepaperExplore 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 |
| WhitepaperLearn 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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