| | By Fraiser Kansteiner Early Friday, Novo shared full, positive results from the FLOW trial assessing the ability of once-weekly semaglutide 1.0 mg to help combat major kidney outcomes such as kidney failure, loss of kidney function and death from kidney or cardiovascular causes in people with Type 2 diabetes and chronic kidney disease. |
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By Annalee Armstrong A Special Report from the Fierce Biotech team on the state of cell therapy. |
By Zoey Becker,Angus Liu,Kevin Dunleavy,Fraiser Kansteiner,Eric Sagonowsky While the global pharmaceutical sales rankings naturally feature the biggest names in the business, each year some new products make their way onto the list. Last year, Merck's PD-1 oncology superstar Keytruda was 2023's bestseller, replacing Pfizer and BioNTech's COVID-19 vaccine Comirnaty. |
By Zoey Becker From early July to March 2025, the Japanese drugmaker will cut 495 staffers at its Cambridge location and 146 in Lexington, Massachusetts. Takeda is the largest life sciences employer in the state. |
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Thursday, June 6, 2024 |11am ET / 7am PT Assessment of antibody off-target reactivity is a regulatory requirement for clinical development. However, conventional screening methods are often ineffective in screening newer therapeutic modalities, and their predictive value for in vivo safety and toxicity is poor. Join us for a look at the new alternatives for success. Register now.
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By James Waldron Daiichi Sankyo and antibody-drug conjugate (ADC) partner AstraZeneca have already filed their Enhertu follow-up Dato-DXd with the FDA, but the latest clinical readout has cast a shadow over the application. |
By Zoey Becker The potentially compromised data included patient information such as names and addresses, Cencora disclosed in letters to patients who may have been affected. |
By Annalee Armstrong Johnson & Johnson’s radiopharmaceutical spurred “profound and durable” responses, however, four patient deaths in the early-stage trial marred the results. |
By Kevin Dunleavy Eli Lilly will invest an additional $5.3 billion in its sprawling construction project in Lebanon, Indiana, where it is building a massive manufacturing complex. The expenditure brings the company's investment in the facility to $9 billion. The project will boost production of active pharmaceutical ingredient (API) for Lilly's injected tirzepatide products Mounjaro, for type 2 diabetes, and Zepbound, for obesity. |
By Helen Floersh A novel, non-hormonal reversible contraceptive for men appears to be effective in mice, the results of a study sponsored by Promega show. When the mice were taken off the drug, their fertility returned. |
By Kevin Dunleavy A recent report from the Yale School of Medicine and Emory University shows that there is little evidence backing the FDA's use of surrogate markers to determine if a medicine is fit for an accelerated approval. |
By Conor Hale This week the agency handed down a Class I recall label to the issue, its most serious designation. The notice does not require any hardware to be returned to the manufacturer. |
Fierce podcastsDon’t miss an episode |
| | This week on "Podnosis," Emma Beavins from Fierce Healthcare interviews CVS Health Chief Medical Officer Sree Chaguturu, M.D., to dive into the topic of telehealth and its role in a comprehensive approach to healthcare. |
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Tuesday, June 11, 2024 | 2pm ET / 11am PT This webinar convenes top industry experts to discuss the transition to privacy-centric, cookie-less marketing solutions that not only ensure compliance but also enhance user engagement. Register now.
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| eBookThis eBook offers insights for business leaders looking to do more with reduced budgets by using the power of SmartIQ’s true forms automation to eliminate the need to print, sign, and scan/mail physical documents, increase operational efficiency, and reduce disparate systems. Sponsored by: SmartComms LLC |
| ResearchDownload this research report to discover how a new predictive model built on consumer attitudinal data can generate improved results for health marketers. Sponsored by: Quad Media |
| Whitepaper Virtual care programs represent a compelling opportunity for decision makers in life sciences companies to drive growth, innovation, and value creation. Download now to learn more. Sponsored by: Wheel |
| WhitepaperHow one top pharma increased literature reviews efficiency by 3x powered by AI -- download today Sponsored by: IQVIA |
| WhitepaperPrecision collection of cell therapy source material doesn’t happen by chance. Our new whitepaper illuminates the science and strategies for successful apheresis. Sponsored by: Comprehensive Cell Solutions |
| WhitepaperLearn how Specifica’s in vitro antibody discovery platform can deliver better antibodies than traditional immunization approaches. Sponsored by: Specifica, a Q2 Solutions company |
| WhitepaperSmall molecule active pharmaceutical ingredients (APIs) continue to grow more complex. Download the white paper to learn more about using synthesis and route design technology to approach API complexity. Sponsored by: Lonza |
| WhitepaperThis paper defines “digital companions” in biopharma, explores their value from the patient & company perspectives, & outlines a process for successfully fielding a new digital companion. Presented by: Blue Matter, strategic consultants in the life sciences |
| eBookTo make every rare disease trial count, we design patient-centric, relevant strategies for sponsors and caregivers to produce impactful results every time. Sponsored by: Emmes Company |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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