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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 NewsNov 28, 2022 |
| By Nick Paul Taylor Concerns are mounting about the safety of Eisai and Biogen’s Alzheimer’s disease prospect lecanemab. Ahead of the presentation of the full phase 3 dataset on Tuesday, Science has reported on the death of a second recipient of the anti-amyloid antibody who suffered a brain hemorrhage. |
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By Nick Paul Taylor AstraZeneca has moved to strengthen its respiratory disease pipeline, wagering $400 million in biobucks for the global rights to a preclinical C4X Discovery NRF2 activator program with applications in chronic obstructive pulmonary disease. |
By James Waldron Spectrum is ending the year as it started it—with a round of layoffs. Friday’s announcement of a 75% reduction in its R&D workforce has been prompted by a complete response letter from the FDA that provided the final nail in the coffin for the biotech’s ambitions for its lung cancer candidate Pozenveo. |
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 Max Bayer The FDA is sending a duo of insulin-related clinical trials in different directions, ending a 14-month partial clinical hold on one while pausing another. Diamyd Medical's phase 3 study has now received the go-ahead and is already been underway in eight European countries. |
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 James Waldron CinCor Pharma is clinging to subgroup analysis despite its mid-stage hypertension study missing its primary endpoint in hopes of advancing the candidate to a phase 3 trial. Investors seemed less convinced, sending CinCor’s shares plummeting 43% in the opening minutes of trading on Monday to $14.80 from a Friday close of $26.53. |
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 James Waldron While AbbVie has mainly been garnering headlines for its cancer and neurological pipelines in recent months, the Big Pharma clearly still has an eye on the inflammatory market. In fact, the company is teaming up with London-based venture fund Deep Science Ventures to create one or more companies targeting this therapy area. |
By Max Bayer The road for anti-TIGIT therapies has been bumpy but Gilead and Arcus are teasing new data they hope will alleviate concerns. The two companies say that an updated interim analysis shows that combination therapies including their own TIGIT are showing improvements compared to an anti-PD-L1 monotherapy. |
By Gabrielle Masson Escient Pharmaceuticals has scored $120M, a much heftier sum than its $77.5M series B from a few years ago and once again snagging support from Big Pharma Sanofi’s VC arm. |
By Nick Paul Taylor Genentech has kicked off a phase 2a clinical trial to optimize subretinal surgical delivery of OpRegen, a cell therapy that is in development as a treatment for the eye disease geographic atrophy. |
By Conor Hale Aidoc obtained two new clearances from the FDA for its artificial intelligence programs that help analyze CT scans to spot dangerous conditions and alert providers. |
By Heather Landi As the primary care market heats up, there is speculation about which medical groups and primary care startups could be in the M&A crosshairs. |
Fierce podcastsDon'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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| 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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