| Editor's Note: The Fierce team will be taking a break for the Presidents Day holiday. Enjoy your long weekend, and we'll be back in your inbox on Tuesday, February 20. |
Today’s Big NewsFeb 16, 2024 |
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Wednesday, February 28, 2024 | 11am ET / 8am PT While oral minitablets can offer several advantages in pharmaceutical applications, manufacturing them can be a complex challenge. Join industry experts for a discussion on the intricate journey of drug development, with a look at how minitablets have redefined formulation strategies, efficacy, patient-centric solutions, options for lifecycle management, and more. Sign up now!
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| By Nick Paul Taylor The dominoes keep falling at Gilead. One week after reporting deaths in blood cancer patients, the Big Biotech has paused enrollment of magrolimab solid tumor trials after the FDA requested a partial clinical hold on the anti-CD47 monoclonal antibody. |
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By Zoey Becker After Sarepta's Elevidys last year scored an FDA approval in a restricted group of patients with Duchenne muscular dystrophy, the company's attempt for a larger indication has snared a priority review. What's more, the FDA doesn't plan to convene an advisory committee. |
By Andrea Park Medtronic has created a new executive role dedicated to achieving the company’s lofty environmental sustainability goals. |
By Fraiser Kansteiner While Johnson & Johnson’s consumer health spinoff Kenvue prepares to move into a new headquarters in Summit, New Jersey, it appears some staffers won’t be joining the company in the transition. |
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Thursday, March 21, 2024 | 11am ET / 8am PT Join us for a discussion on the evolution of HCP engagement through the lens of Customer Science – the integration of data science, behavioral science, and AI. In this webinar, we explore how Customer Science brings substantial benefits to commercial leaders, providing a deeper understanding of HCPs and patients for more effective engagement. Register now.
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By Max Bayer Astellas is betting up to $800 million on Kelonia's in vivo genetic delivery tech through its cell therapy subsidiary Xyphos. Kelonia will earn $40 million in an upfront payment for the first candidate from the deal. |
By Kevin Dunleavy Four months after the FDA rejected Sanofi and Regeneron’s Dupixent to treat chronic spontaneous urticaria, Japan’s health regulators have signed off on the drug in the indication. |
By James Waldron Inventiva has paused enrolling new patients into a phase 3 trial of its lead liver disease drug after one participant experienced raised enzyme levels. |
By Fraiser Kansteiner After picking up European rights to a pair of Eli Lilly migraine meds in December, Organon is hungry to ink more deals. |
By Andrea Park After kicking off 2024 with the news that it had begun restructuring its manufacturing footprint, and following last summer’s sell-off of two product portfolios, AngioDynamics is putting more of its vascular devices on the chopping block. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," Max Bayer from Fierce Biotech explores the future of gene editing in an interview with the CEO of Verve Therapeutics. |
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| Whitepaper This paper offers a detailed review of key events and developments in the oncology market during 2023. It’s a helpful “status report” that informs how the market is likely to evolve in 2024. It covers, vaccines, radiopharmaceuticals, ADCs, CAR-Ts, bi-specifics, & more. Presented by Blue Matter, strategic consultants in the life sciences |
| Whitepaper Discover how to effectively classify highly potent APIs and the steps required to develop containment protocols and manufacturing processes that are both safe and efficient. Sponsored by: Catalent |
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