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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 15, 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 Annalee Armstrong Last month, BioCryst trimmed down its pipeline to two drugs in complement-mediated diseases: BCX9930 and BCX10013. Fast forward 45 days and BCX9930 is headed to the garbage can, too. |
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By James Waldron Axcella is reducing its workforce by 85% as it drops its nonalcoholic fatty liver disease program and focuses its remaining resources on its long COVID candidate. |
By James Waldron The curse of raised liver enzymes has struck again, with Third Harmonic the latest company to discontinue a phase 1b study of its lead asset over two reports of liver toxicity. |
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 Sio Gene Therapies has kept its head down since dropping its final two assets and most staff in April, but the company has finally confirmed that it’s shutting up shop for good. |
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 Max Bayer Innovent is adding a new late-stage med to its pipeline, buying the Chinese rights to LG Chem’s phase 3 gout disease treatment for nearly $100 million. |
By Helen Floersh Takeda is seeing some positive signals from its $3.6 billion deal with Poseida Therapeutics with promising preclinical data on the companies’ hemophilia A therapy P-FVIII-101. |
By Kevin Dunleavy The FDA has delayed its target date for its decision on AstraZeneca and Merck's Lynparza in metastatic castration-resistant prostate cancer (mCRPC). The agency has pushed back the decision date by three months to “provide further time for the full review of the submission,” Merck said. |
By Frank Diamond Long COVID was listed as the cause of death on 3,544 death certificates, according to a new CDC study. The real number might be higher, experts warn, and a new code might make it easier to calculate that number. |
By Andrea Park Hot on the heels of the U.S. launch of its recharge-free neurostimulation implant to treat incontinence, Axonics is bringing yet another of its sacral neuromodulation devices to our neighbors to the north. |
By Joseph Keenan Merck & Co. and Indonesia’s Bio Farma entered a licensing agreement for the state-owned drug manufacturer to produce the MSD four-valent HPV vaccine locally. |
By Robert King CMS proposed new policies for Medicare Advantage and Part D plans, including streamlining prior authorization and adding a health equity index to star ratings. |
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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