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Cell therapy developers face many challenges as they transition from benchtop to bedside.Here we examine when and how to consider transitioning from research-use-only to animal-free (AF) and GMP critical reagents. Download now. 
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Today’s Big NewsJul 11, 2024 |
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September 25-27, 2024 | Philadelphia, PA Join the Fierce Clinical Summit, the premier event for clinical research and trial management. Explore topics in Clinical Operations, Quality, and DCT & Technology. Learn, network, and connect with peers to advance industry standards and innovations in clinical trials. Secure your pass today! 
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| By Zoey Becker Novo Nordisk's Ozempic is slated to take over No.1, while Merck's Keytruda falls to No.9 on Evaluate's predicted rankings of top drugs by 2030 sales. |
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By Nick Paul Taylor Pfizer has dragged the oral GLP-1 candidate danuglipron back from the brink. Months after dropping one version of the asset, the Big Pharma has vowed to advance a once-daily, modified-release formulation on the strength of “encouraging pharmacokinetic data.” |
By Annalee Armstrong The obesity game is only in its early innings, and the future market will be defined by who can ease administration of the medicines, according to a new report from Evaluate. |
By Conor Hale Looking to be more upstart than startup, Element Biosciences aims to take on the DNA sequencing giant located right down the road in San Diego. |
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Dive into the cutting-edge world of recombinant antibody engineering, from optimizing your antibody plasmid to antibody maturation and humanization. Explore innovative techniques and strategies that enhance antibody efficacy, paving the way for breakthroughs in therapeutic development. Download now. 
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By Fraiser Kansteiner On top of Eisai and Biogen's Leqembi, Kisunla’s approval likely marks the “end of the beginning in treating this disease,” Andrew Lechleiter, VP of U.S. Alzheimer’s disease marketing at Eli Lilly, said during a recent interview. |
By Kevin Dunleavy The FDA has slowed the roll for Novo Nordisk, rejecting its once-a-week insulin icodec for patients with Type 1 and Type 2 diabetes. In a complete response letter, the U.S. regulator made "requests related to the manufacturing process and the type 1 diabetes indication," which the company said it does not expect to remedy by the end of this year. |
By James Waldron An R&D center in San Diego is the latest area to be impacted by Novartis’ ongoing global development restructure, the company has confirmed. |
By Conor Hale BD said the issue with its BACTEC vials stems from manufacturing problems at its current plastic bottle supplier. The FDA expects the shortage to continue through Q4. |
By Angus Liu As it ends a licensing agreement with CSL Vifor, Akebia has priced its chronic kidney disease anemia drug Vafseo by incorporating an uncertain future label expansion that it plans to discuss with the FDA later this year. |
By Nick Paul Taylor Ogilvy Health has added to the roster at its Singapore office, hiring Sofia Beccarelli as associate planning director for APAC to support key regional clients “with their marketing transformation.” |
By Helen Floersh Young adult mice with a genetic form of progressive deafness can hear again after being treated with an experimental CRISPR gene therapy that its creators hope to eventually use in humans. |
Fierce podcasts Don’t miss an episode |
| In this week’s episode of “Podnosis,” Executive Editor Heather Landi chats with Rock Health’s Megan Zweig to talk about the state of the digital health market, how startups and investors are taking a different approach to dealmaking and what to expect for the rest of the year. |
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Implementing effective corrective and preventive actions (CAPAs) to address rejects is essential to meeting regulatory requirements and to improving the manufacturing of sterile dosage forms going forward. This report examines the causes of high reject rates in sterile dosage manufacturing and describes how biopharmaceutical developers and CDMOs can work together to develop a strong CAPA strategy. Download now. 
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Whitepaper In this white paper, Lonza experts delve into the common challenges encountered by ADC developers. They explore new drug product capabilities in relation to cytotoxic drug development and manufacturing, therefore fully completing Lonza’s integrated ADC offering. Further, they discuss how this end-to-end approach can significantly accelerate the timeline to investigational new drug filing and beyond. Read this white paper to learn more. Sponsored by: Lonza |
Whitepaper The definitive report on the state of our industry. Readers will gain an understanding of key indicators to monitor, future predictions, and guidance for investors and founders navigating the therapeutic enabling tools and services, healthtech and techbio sectors through 2024 and beyond. Sponsored by: AVANT BIO |
Whitepaper In a complex industry like biopharma, being a “Best Practice Organization” (BPO) is essential to success. But what is a BPO & how do you build one? This eBook provides the answers. Sponsored by: Blue Matter, strategic consultants in the life sciences |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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