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Transform the Industry with Your Innovation! Submissions are now open for the Fierce Life Sciences Innovation Awards. Click to submit your entry and learn more about the categories and criteria.
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Today’s Big NewsAug 2, 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 up to $500 with Early Bird Rates. Register Now!
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| By James Waldron The “strategic restructuring” is designed to push more resources into Vir’s hepatitis programs “and focus on the highest near-term value opportunities,” the biotech explained. |
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By Zoey Becker As of mid-July, around 20 patients completed the first step of Casgevy treatment by having their cells collected, up from five patients during the first quarter. |
By Nick Paul Taylor Vertex’s attempt to treat a rare genetic disease has hit another setback. The biotech tossed two more drug candidates onto the discard pile in response to underwhelming data but, following a playbook that has worked in other settings, plans to use the missteps to inform the next wave of preclinical prospects. |
By Kevin Dunleavy Adaptimmune has won accelerated FDA approval for Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma which becomes the first engineered cell therapy for a solid tumor and the first new treatment in the indication in more than a decade. |
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Sept. 25 - 26, 2024 | San Diego, CA Cutting-edge educational sessions: Gain insights from industry leaders. Early Bird Rate ends August 2nd, Save $400, Register Today!
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By Conor Hale The DePuy Synthes division’s Velys Spine system is designed to offer what the company describes as active robotic assistance, which tracks patient movements. |
By Darren Incorvaia Flesh-eating bacteria sound like something an enterprising science fiction author would dream up, but they are in fact real—and the infections they cause can lead to disfigurement, loss of limbs, and even death. |
By Kevin Dunleavy Novartis has filed a lawsuit against the FDA, claiming that the U.S. regulator’s approval of a generic version of Entresto is unlawful. The complaint comes a week after the FDA approved an Entresto generic from MSN Laboratories. The agency also rejected a Novartis-led Citizen Petition, which asked it to block the entry of generic versions of the blockbuster drug. |
By Nick Paul Taylor Galapagos has paused enrollment in a trial of a BCMA-directed CAR-T cell therapy, pumping the brakes in response to an adverse event also seen in recipients of Bristol Myers Squibb and Johnson & Johnson’s rival drugs. |
Fierce podcastsDon’t miss an episode |
| | This week on “The Top Line,” we dive into two studies in HIV research that were presented at the 25th International AIDS Conference in Germany. |
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Wednesday, September 11, 2024 | 2pm ET / 11am PT As the drug development landscape rapidly evolves, artificial intelligence (AI) is emerging as a transformative force, fundamentally reshaping processes and enhancing efficiencies. Join us for a deep dive into AI’s significant impact on streamlining clinical project management, revolutionizing the generation of crucial research outputs and accelerating drug discovery. Register now.
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| WhitepaperThis paper explores the costs of setting up a supply chain in Europe for a new biopharma therapy. It outlines key cost drivers & the various levers decision makers can use to affect those costs. Sponsored by: AIM |
| WhitepaperDownload the white paper to learn how this innovative solution can help optimize your mAb production processes. The findings demonstrate the system's robust capability to sustain strong cell growth and high productivity, facilitating a smooth transition from laboratory to production scale. Sponsored by: Thermo Fisher Scientific |
| WhitepaperIn this white paper, Lonza experts delve into the common challenges encountered by ADC developers. They explore new drug product capabilities in relation to cytotoxic drug development and manufacturing, therefore fully completing Lonza’s integrated ADC offering. Further, they discuss how this end-to-end approach can significantly accelerate the timeline to investigational new drug filing and beyond. Read this white paper to learn more. Sponsored by: Lonza |
| 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 |
| WhitepaperIn a complex industry like biopharma, being a “Best Practice Organization” (BPO) is essential to success. But what is a BPO & how do you build one? This eBook provides the answers. Sponsored by: Blue Matter, strategic consultants in the life sciences |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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