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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 13, 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 Nick Paul Taylor Merck & Co. has shown why it bet $250 million on Moderna’s mRNA cancer immunotherapy. Weeks after Merck opted into the program, the partners have revealed the personalized candidate reduced the risk of recurrence or death by 44% when given to melanoma patients in combination with Keytruda. |
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By James Waldron While more pharmas big and small are pursuing “off-the-shelf” CAR-T therapies, Novartis has been blazing its own trail. The Swiss drugmaker has been fine-tuning its T-Charge platform to speed up the process by ensuring most of the CAR T-cell expansion occurring within the patient’s body. |
By Max Bayer Novartis is touting expanded phase 3 data of its rare blood disease med after an initial readout showed significant benefits compared to a couple of AstraZeneca assets. Citing the data, a top Novartis development executive said in an interview that the results support full approval from regulators. |
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 Nick Paul Taylor Nimbus Therapeutics’ midphase psoriasis data have persuaded Takeda that the biotech’s TYK2 inhibitor will be big. How big? $4 billion upfront and more again on the back end big. |
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 GSK has added another oligonucleotide to its pipeline, with potentially plenty more to follow courtesy of a $170 million upfront collaboration with Wave Life Sciences. |
By Annalee Armstrong Regeneron is boasting about having the highest complete response rate for advanced follicular lymphoma, but a question hangs heavy over the most recent data: Can the bispecific overcome a slate of deaths and serious adverse events that have occurred in several trials? |
By Angus Liu A new BTK inhibitor could be in town soon. With a different construct compared with the three incumbents, the Eli Lilly candidate is angling for a unique treatment setting. |
By James Waldron Nordic Nanovector is in a race to recruit a suite of directors from scratch as well as a new CEO after the boardroom resigned in the wake of the failed acquisition of APIM Therapeutics. |
By Helen Floersh Scientists have figured out how to develop synthetic adhesion molecules that could one day be used to build new organs and treat disease. |
By Kevin Dunleavy Manufacturing veteran Paul McKenzie, Ph.D., takes the reins at blood products specialist CSL after serving three years as its chief operating officer. McKenzie headed up manufacturing and supply chain management at Biogen before coming to Australia-based CSL in 2019. |
By Andrea Park Joining Tandem on its bicycle built for two is AMF Medical, the Swiss developer of a patch pump for automated insulin delivery. |
By Angus Liu A clinical trial that started before the first FDA approval for Blincyto might support a new use for the Amgen therapy in acute lymphoblastic leukemia. |
By Heather Landi The All of Us research program has begun returning personalized health-related DNA results to participants, marking the largest-scale effort to date to share genetic and pharmacogenetic information with study participants and a major milestone for the project. |
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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