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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 27, 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 Eric Sagonowsky Years of negotiations and legal proceedings surrounding a high-dollar opioid settlement for Purdue Pharma have reached a dead end at the U.S. Supreme Court. |
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By Angus Liu In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate patritumab deruxtecan. |
By Gabrielle Masson 2seventy bio has split again, this time sending its hemophilia A program and related staff to Novo Nordisk. |
By Kevin Dunleavy Verona Pharma has earned an FDA approval for Ohtuvayre, a potential blockbuster with a novel mechanism of action, to treat patients with chronic obstructive pulmonary disorder. It is the first novel treatment advancement in the indication in more than a decade. |
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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 Gabrielle Masson AbbVie is embracing summer’s heat, cranking up the M&A dial with the acquisition of inflammatory disease-focused Celsius Therapeutics for $250 million cash. |
By Conor Hale The TB-focused project with the FDA follows up on the Gates Foundation's interest in breath biopsy tests developed by Owlstone Medical. |
By Helen Floersh Six months after its due date, the FDA’s draft guidance for clinical trial diversity is finally here. The agency issued a new outline of its proposed requirements for the racial and ethnic diversity action plans that will eventually be mandatory components of studies on drugs, devices and other medical products. |
By Zoey Becker The vaccines are now recommended for adults aged 75 years and older and those aged 60 to 74 with a higher risk of severe disease. Previously, all adults aged 60 and older were advised for vaccination. |
By Nick Paul Taylor Add medical education to the list of areas artificial intelligence could transform. Healthcare professionals are keen to see the technology deployed, with more than half of respondents to a survey saying it could improve how they learn by powering features such as video summaries and personalized content. |
By Zoey Becker Rovi's potential CDMO unit sale has attracted buyout offers, the company confirmed. The unit generated 409 million euros last year. |
By Conor Hale After spinning out its spine business earlier this year, ZimVie is now considering selling off the remaining entirety of its dental operations, according to a report from Bloomberg. |
By Kevin Dunleavy Seventeen months after SK Bioscience introduced its global expansion push, the Korean developer and manufacturer of vaccines has pulled off a deal that lives up to its ambitions. SK has acquired a 60% stake in IDT Biologika GmbH for 339 billion won ($244 million). |
By Angus Liu With Regeneron's treatment delayed, AbbVie is expanding its T-cell engager competition against Roche in blood cancer with a new FDA approval. |
Fierce podcastsDon’t miss an episode |
| In this week's episode of "The Top Line," journalists from Fierce Biotech and Fierce Pharma discuss the most talked-about data drops at ASCO and share on-the-ground details, including their experience with Gilead’s virtual reality Trodelvy ride. |
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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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