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Create an optimal path to the clinic that best suits your molecule and critical milestones. We now offer a full suite of integrated drug substance/drug product DNA-to-IND programs to accelerate any molecule type to the clinic. Download our white papers to learn more about our tailored CMC strategies.
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Today’s Big NewsJun 26, 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. Save $500 with Early Bird Rate Today!
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| By Gabrielle Masson Novo Nordisk’s late-stage kidney disease drug failed to evoke significant changes in systolic blood pressure, a loss that will cost the Danish drugmaker more than $800 million. |
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By Fraiser Kansteiner Amarin is getting a fresh shot to challenge Hikma Pharmaceuticals’ generic version of its fish oil-derived heart med in the lower courts. But the legal development comes after a patent loss on Vascepa eviscerated its U.S. business. |
By Conor Hale BillionToOne said the proceeds will help scale up its blood testing businesses in prenatal screening and cancer. |
By Andrea Park Though a host of drugs currently under development are poised to massively expand the existing market for chronic kidney disease (CKD) treatments, they’ll need to go further to win the support of doctors, according to a new report. |
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Achieving complete and informed drug discovery and clinical development requires the right mix of clinical, claims and other real-world data (RWD). Access this insightful resource to learn how to do just that. Download now.
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By Nick Paul Taylor A death and other adverse events have forced Lyell Immunopharma to take a two-track approach to its early-phase CAR-T clinical trial, holding back dose escalation in people with lung metastases while racing ahead in the wider population. |
By Angus Liu Even after the FDA has converted J&J’s Rybrevant use in previously treated EGFR exon20 insertion-mutated non-small cell lung cancer into a full nod, the door to an accelerated approval in the same indication remains open, according to AstraZeneca spinout Dizal Pharma. |
By Conor Hale Surgeons at Northwestern Medicine transplanted a kidney into a fully awake patient—yes, on purpose—and were able to discharge him the next day, in what they described as basically an outpatient procedure. |
By Gabrielle Masson Venture capital firm Curie.Bio has fueled up, raising $380 million for biotech founders and promising to stretch the runway of seed money for better long-term results. |
By Fraiser Kansteiner As other immunology players make inroads into the giant cell arteritis arena, one of Johnson & Johnson’s top-grossing medicines, Tremfya, has come up short in the disease. |
By James Waldron Megarounds have been few and far between in 2024, but Formation Bio has managed to draw in an impressive $372 million series D as the AI-focused biotech seeks to expand its pipeline. |
By Kevin Dunleavy Sanofi has told prospective buyers of its consumer health unit to provide bids for its consumer division by the middle of July, Bloomberg reports. Private equity firms Advent International and PAI Partners are believed to be the most serious potential suitors. |
Fierce podcastsDon’t miss an episode |
| In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing. |
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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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| WhitepaperThe 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 |
| WebinarWatch our on-demand webinar video to learn more about the challenges in pDNA manufacturing for gene and cell therapy and how to resolve many of these barriers by partnering with our experts through the adoption of vital manufacturing technologies and strategies. Sponsored by: Aldevron |
| WhitepaperNew molecular formats are gaining momentum in today’s market. Characterizing these products and developing robust manufacturing processes can help to usher them to market and provide new treatment options for diseases which are currently challenging to treat. Read this white paper to learn more. Presented by: Lonza |
| WhitepaperThis paper outlines the challenges, pitfalls, & solutions associated with adding rare disease therapies to a biopharma company’s portfolio. Sponsored by: AIM, the strategic leader in life science supply chains |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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