| Today’s Big NewsJun 14, 2024 |
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Tuesday, June 25, 2024 | 11am ET / 8am PT Expanded Access Programs can help deliver life-saving access to critical medications. Join us for a deep dive into the benefits of EAPs in Europe. Learn how to leverage for achieving faster access to the European market, facilitating successful commercialization, and navigating the array of regulations and guidelines. Register now. 
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| By Gabrielle Masson New data presented at 2024’s European Hematology Association meeting show how Gilead's bet on its now-abandoned CD47 drug magrolimab failed to deliver left and right. |
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By Zoey Becker In deal potentially worth up to $1.3 billion, Takeda has gained an option to license Ascentage's third-generation tyrosine kinase inhibitor, which could go up against Novartis' Scemblix in chronic myeloid leukemia. |
By Gabrielle Masson,Andrea Park,Fraiser Kansteiner Longtime J&J exec Willaim Hait, M.D., Ph.D., is set to retire this fall after a 17-year run with the Big Pharma. |
By Kevin Dunleavy Six months after Vertex earned a historic FDA approval for sickle cell disease (SCD) gene therapy Casgevy (exa-cel), long-term data is beginning to show the consistent efficacy and durability of the treatment, which is the first ever to be developed using CRISPR gene editing technology. |
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Wednesday, June 26, 2024 | 2pm ET/ 11am PT In this webinar, we outline a patient-centered telehealth genetic counseling model that accelerates time to meet recruitment goals by engaging and recruiting genetically eligible participants. Certified genetic counselors are uniquely qualified to support the development of a multi-phased approach to patient identification and screening, disclose genetic test results, and more. Register now. 
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By James Waldron Investors celebrating the summer resurgence of biotech IPOs might want to put the champagne back on ice, after Telix Pharmaceuticals made the last-minute decision to pull its own Nasdaq listing plans. |
By Conor Hale The FDA is joining hands with regulators in Canada and the U.K. on policies to ensure transparency in the development of medical devices powered by machine learning. |
By Angus Liu A Bristol Myers Squibb drug has got an FDA approval to treat tumors with a specific biomarker regardless of their locations in the body, and it's facing two competitors. |
By Gabrielle Masson J.P. Morgan Private Capital has closed an inaugural life sciences fund of more than $500 million, cash that will go toward a wide range of private biotechs and build value for existing portfolio companies. |
By Ayla Ellison,Gabrielle Masson,Angus Liu 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. |
By Annalee Armstrong Cabaletta Bio’s shares tumbled 13% Friday morning as the biotech shared just a crumb of data from two patients in an autoimmune CAR T trial that hinted at remission. |
By Fraiser Kansteiner MilliporeSigma is plugging €62 million (about $66.3 million) into the build-out of a new quality control building at its Darmstadt, Germany, headquarters. The facility will ultimately unite some 135 employees across several departments into a single space, the company said in a press release. |
By Andrea Park A maker of health education podcasts—including installments sponsored by major biopharma and medtech players—is adding a subscription model to power future development of even more audio content. |
Fierce podcasts Don’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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Biotech companies must be able to navigate the complexities of development and approval. Learn how to drive improved speed, quality, predictability, and risk management by making key changes. Download now for exclusive insights. 
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Webinar Watch 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 |
Whitepaper New 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 |
Whitepaper This 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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