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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 12, 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 Roche’s attempt to muscle in on paroxysmal nocturnal hemoglobinuria is on track. The subcutaneous anti-C5 recycling antibody crovalimab improved outcomes in a Chinese phase 3 trial, giving the Big Pharma a boost as it closes in on data from its showdown with AstraZeneca’s Soliris. |
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By Nick Paul Taylor Two years ago, clouds gathered over Regeneron blood cancer candidate odronextamab after it reported five treatment-related deaths and the FDA placed a clinical hold on studies. Now, Regeneron is back with the data it hopes will secure approval—and has again reported five deaths linked to the therapy. |
By Angus Liu Five years after Legend Biotech made a splash with an initial 100% tumor response rate for what would later become J&J-partnered Carvykti, another Chinese company has repeated the same remarkable data for its BCMA-targeted CAR-T therapy in first-line multiple myeloma. But several Big Pharma companies are honing their next-generation BCMA candidates, too. |
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 Angus Liu Less than six months into the $1.9 billion acquisition of Sierra Oncology, GSK has started to explore the possibility of new indications for the deal centerpiece, JAK inhibitor momelotinib, Hesham Abdullah, GSK’s global head of oncology development, told Fierce Biotech at #ASH22. |
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 Annalee Armstrong Cytokinetics will finally get the chance to make the case for its heart failure drug to the FDA's advisory committee next week. But it seems the agency is uneasy about the single study used to support the application and whether that phase 3 test covered some of the company's asks. |
By Max Bayer Janssen is unveiling additional phase 2 data of its new multiple myeloma bispecific antibody in patients looking for a life preserver after treatment failures. The data comes on the heels of the company formally asking U.S. regulators for approval last week. |
By Conor Hale,Andrea Park When we added up the salaries, stock options, vested shares and bonuses awarded across the industry, we found some interesting additions to our list of the biggest medtech bigwigs. |
By Fraiser Kansteiner It’s official: Just weeks after rare disease drug maker Horizon Therapeutics revealed it was at the heart of a bidding war between Amgen, Johnson & Johnson and Sanofi, Big Biotech Amgen has emerged with a multibillion-dollar M&A victory. |
By Heather Landi A federal appeals court ruled that the Biden administration cannot force religious healthcare providers to perform or pay for gender transition surgeries as it violates the religious rights of some Catholic organizations. |
By Kevin Dunleavy Roche’s leadership shuffle, which began in July, continued on Monday with the departure of pharma sector CEO Bill Anderson, who took over in 2019. But this year, the sector’s fortunes declined with several clinical setbacks. Anderson is leaving at the end of this year to “pursue other opportunities,” the company said in a release. |
By Conor Hale Acotec maintains a portfolio of drug-coated balloons and angioplasty hardware, all approved in China and backed by a local sales network. |
By Fraiser Kansteiner GSK will soon be moving on up to a new global headquarters in central London, the British pharma said Monday. The company will move to the new HQ from its current location in Brentford, West London, in 2024. |
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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