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March 14-15, 2023 | San Francisco, CA Get an unequaled in-depth examination of partnership strategies, licensing priorities, and ways to avoid everything that can go wrong with your next big deal. Don’t miss out on this unique learning and networking opportunity. Register Now!
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Today's Big NewsDec 14, 2022 |
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If the clinical supply chain is poorly managed, sponsors can struggle to cope with the complexities, causing issues. This playbook covers keys to identifying the need to implement an eClinical Supply Chain Management platform. Download now.
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| By Max Bayer FDA advisers said the risks of Cytokinetics' heart failure med outweigh the benefits, pouring cold water on the drug's approval prospects as it awaits a definitive decision from the agency. The company attempted to elevate data showing that the med was particularly useful in the sickest patients. |
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By Nick Paul Taylor The unraveling of Exicure continues apace. Weeks after the biotech raised the specter of bankruptcy, AbbVie and Ipsen have terminated their hair loss disorder and rare neurodegenerative disease collaborations with the company. |
By Nick Paul Taylor Kymera Therapeutics has generated the first early clinical evidence that its targeted protein degradation technology works in immune-inflammatory diseases. In a small phase 1 trial, Kymera linked the IRAK4 candidate to improvements in symptoms, encouraging its partner Sanofi to take the program forward. |
Sponsored by Personalis If you’re in translational research, you know how challenging trial design and regulatory approval can be. See how the NeXT generation of ctDNA analysis is a major asset for improving informed cancer strategies. |
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This playbook looks at why insolubility is an issue, and the properties that affect solubility, such as the molecule’s structure; its physical attributes (particle size and dissolution rate); its chemical attributes, including compatibility with excipients; and its biological properties. Download now.
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By James Waldron It’s been a tough year of layoffs and pipeline culls for Praxis Precision Medicines, but the biotech is ending 2022 on a high courtesy of a collaboration with UCB to develop a potential first-ever treatment for a specific type of epilepsy. |
Sponsored by Danaher Corporation Genomic Medicines could cure the world’s toughest diseases. The Danaher Genomic Medicines Summit convened many of the field’s top leaders to discuss challenges and strategies for creating a world without disease. |
By James Waldron Eight months after the failure of Vallon Pharmaceuticals’ only clinical asset sent the biotech on a hunt for an escape route, the floundering company’s story has come to an end thanks to an acquisition by GRI Bio. |
By Max Bayer Avidity is looking to stir up enthusiasm for its siRNA treatment amid an FDA partial clinical hold first placed in September. |
By Teresa Carey This week on "Podnosis," we talk about how insurers are meeting the demands for techie solutions. We also discuss how to fix primary care. |
By Fraiser Kansteiner Senator Elizabeth Warren of Massachusetts and Vermont senator-elect Peter Welch blasted Pfizer’s purported Comirnaty pricing scheme—which could see the company charge between $110 and $130 per vaccine dose on the private market—as “pure and deadly greed.” |
By Jacqueline Renfrow AstraZeneca and Merck & Co. are teaming up to launch a new, global prostate cancer awareness campaign called “Never Miss,” which marries the universal love of sports with getting out the word about the risks of prostate cancer. |
By Andrea Park HistoSonics' noninvasive ablation technology directs focused ultrasound toward targeted tissue from outside the body. The company is focusing first on attacking tumors in the liver. |
By Robert King HHS proposed a rule to make permanent key flexibilities that removed barriers to access for opioid use treatments such as buprenorphine. |
Fierce podcastsDon't miss an episode |
| This week on “The Top Line,” we discuss the latest from the Clinical Trials on Alzheimer’s Disease conference. Plus, we cover the week's news including an investigation into Neuralink, Google’s DeepMind and why things aren't working out for PI3Ks. |
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Tuesday, January 24, 2023 | 11am ET / 8am PT UGTs are the most common enzymes involved in metabolism after CYP enzymes, followed by numerous hydrolases, carbonyl reductases, aldehyde oxidase and other enzymes. Hear Dr. Brian Ogilvie discuss case studies and strategies to address non-CYP related metabolism questions in your drug’s safety assessment. 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 |
| 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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