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When the world is changing, you need a global CDMO with a strong global presence to protect your molecule. Our team of experts help progress any molecule type, however complex, from pre-clinical to commercial.
Learn more about our tech transfer capabilities.
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Today’s Big NewsSep 17, 2024 |
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Tuesday, September 24, 2024 | 2pm ET / 11am PT The transition from clinical to commercial supply chains is a pivotal challenge for life sciences organizations today. Join us for this important and timely discussion with industry experts for a deep dive into the scaling of logistics operations, and how to successfully navigate the complexities. Register now.
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| By Angus Liu An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis' Kisqali and Eli Lilly's Verzenio in early breast cancer. |
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By Nick Paul Taylor A phase 3 trial of Daiichi Sankyo and Merck & Co.’s HER3-directed antibody-drug conjugate has hit its primary endpoint, boosting plans to take a second shot at FDA approval. But two more people died after developing interstitial lung disease, and the overall survival data are immature. |
By Conor Hale Developed by Senseonics and Ascensia Diabetes Care, the Eversense 365 implant got the go-ahead for adults with Type 1 or Type 2 diabetes. |
By Fraiser Kansteiner Thanks to “over-commitments and capacity constraints” facing the U.S.-based contractor in charge of final packaging for Coherus' Udenyca, the copycat cancer med will suffer a “temporary” supply interruption, the company said last week. |
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Thursday, September 25, 2024 |11am ET / 8am PT In the fast-evolving field of cell and gene therapy, overcoming bottlenecks at every stage of the process is crucial. Join us to learn about best practices, innovative solutions, and strategies to enhance efficiency in cell and gene therapy manufacturing, management, and delivery. Register now.
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By Nick Paul Taylor Ascendis Pharma has emerged as a potential threat to BioMarin’s Voxzogo, reporting phase 3 growth disorder data that exceeded analyst expectations and positions the biotech to file for approval next year. |
By Ben Adams New biologics such as GSK's Benlysta and AstraZeneca's Saphnelo, along with off-label drugs, have been the mainstay for systemic lupus erythematosus treatment for many years. However, the landscape may be about to change with the introduction of new medicines and indications from other approved treatments. |
By Conor Hale The FDA is getting the word out regarding a recall effort from Zimmer Biomet, related to its discontinued CPT hip implant and its potential link to fractures of the thigh bone after placement. |
By Kevin Dunleavy Three months after a jury awarded $260 million to an Oregon woman who claimed that her use of Johnson’s Baby Powder caused her to develop mesothelioma, a state judge has overturned the verdict and granted the company a new trial. |
By Gabrielle Masson Though Alkeus Pharmaceuticals’ oral eye disease asset failed to significantly reduce geographic atrophy (GA) lesion growth, the biotech is citing "clinically meaningful" results and a secondary endpoint win as reasons to pursue further development. |
By Nick Paul Taylor GSK has turned to Brooke Shields to get the message out about shingles vaccination. The drugmaker has worked with the model and actor to talk to female celebrities and patients aged 50 years and up about the power that comes from aging and how shingles threatens their health. |
By Zoey Becker After last year's supply issues put a strain on the launch, Sanofi and AZ expect enough supply this year to cover every eligible infant in the U.S. |
Fierce podcastsDon’t miss an episode |
| | In this week's episode of "Podnosis," we look at how practice management companies are meeting the evolving needs of healthcare providers. |
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Who’s Leading the Way in Clinical Research? Nominate Them for the CRO Awards! The Fierce CRO Awards shine a spotlight on the organizations that are setting new standards in clinical research and development. If your CRO excels in innovation, quality, and leadership, it’s time to get the recognition you deserve. Submissions close October 3rd. SUBMIT NOW
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| WhitepaperUnique Solutions for Drug Discovery and Development Sponsored by: Cell Signaling Technology |
| WhitepaperWhen the fate of your company hangs in the balance, you need expert guidance to navigate the complexities of biotechnology development and to make informed decisions. Sponsored by: WCG |
| WhitepaperPower non-invasive, self-sampling solutions using the Colli-Pee™️ first-void urine collection device. Learn more. Sponsored by: DNA Genotek |
| WhitepaperFacing roadblocks in drug development? Uncover how phase-appropriate technology transfers can help you navigate challenges and speed up your journey to market. Sponsored by: Veranova |
| WhitepaperWe interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned. Sponsored by: Blue Matter Consulting |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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