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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 2, 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 Angus Liu,Fraiser Kansteiner After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval. |
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By Conor Hale Nearly 300 of Masimo's engineers and managers—as well as its COO—have signed letters saying they might follow the company's founder out the door. |
By Nick Paul Taylor Cartesian Therapeutics has claimed a phase 2b win for its BCMA-directed CAR-T therapy in generalized myasthenia gravis. But the biotech’s victory came on a primary endpoint it changed in May and in a population that excluded the 25% of participants treated at community clinics. |
By Andrea Park Under federal law, former FDA employees are prohibited from engaging in certain lobbying activities—but an investigation published in the BMJ on Monday claims that the agency’s staffers are often advised of loopholes in those regulations on their way out the door. |
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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 James Waldron Moderna has become the latest biopharma to benefit from the U.S. Department of Health and Human Services’ concerns about avian flu, awarding the company $176 million to fund the clinical development of a potential vaccine. |
By Fraiser Kansteiner As Korean CDMO giant Samsung Biologics continues to ink production pacts around the globe, the company has added another billion-dollar feather to its cap. |
By Angus Liu Even as the BIOSECURE Act works its way through the legislative process, the draft bill has already caused a slide in U.S. life sciences companies' confidence in Chinese partners, a new survey has found. |
By Conor Hale The FDA has greenlit its first point-of-care diagnostic test for hepatitis C, capable of using only a fingerstick blood sample, in a bid to quickly connect patients with antiviral drugs. |
By Ben Adams Otsuka and Lundbeck’s CNS drug Rexulti has for the second time this year claimed the top spot as the leading TV drug ad spender. |
By Gabrielle Masson,Max Bayer We really didn't want to have to create another Layoff Tracker this year. But here we are, launching the third annual iteration tracking biopharma layoffs. |
By Nick Paul Taylor Which companies do Americans associate most with weight loss medication? If you answered Eli Lilly or Novo Nordisk, think again. The two leading obesity drug makers were relegated to third and fourth spot behind a pair of companies without an authorized weight loss medicine between them. |
By Andrea Park For its latest celebrity partnership, Pfizer went in a “Fabulous” direction. |
Fierce podcasts Don’t miss an episode |
| In today’s episode of "The Top Line," Fierce Biotech’s Annalee Armstrong and James Waldron discuss what they think are the best and smartest biopharma acquisitions in recent years. |
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Download this resource to accelerate your oncology clinical trials, optimize patient enrollment, and monitor minimal residual disease and molecular response effectively. Explore how this tissue-free, methylation-based technology enhances circulating tumor DNA (ctDNA) detection, enriching trial populations and evaluating therapy responses faster than tissue assays. 
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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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