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A very small percentage of nonclinical lead assets move into the clinic. That’s why it is crucial to develop an optimized nonclinical strategy that leverages smart planning and design to de-risk critical early-stage milestones. It could mean the difference between success and failure. Read our guide to ensure your nonclinical program has the best chance to advance to Phase 1 – and beyond.
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Today’s Big NewsMay 7, 2024 |
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Tuesday, May 14, 2024 | 9:30am ET / 6:30am PT This webinar dives into patient-derived organoids viewed as the gold standard in bridging the gap between the lab and the clinic. The oncology portfolio allows researchers to incorporate patient relevance at every stage of the drug development pipeline - from target discovery and hit identification to lead validation and optimization. Register now.
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| By Annalee Armstrong Mark your calendars: Eli Lilly will come before the FDA’s advisory committee to discuss Alzheimer’s disease medicine donanemab June 10. |
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By Max Bayer Zenas BioPharma has raised a $200 million series C to fund further clinical development of its lead autoimmune treatment. The company expects four mid-to-late-stage readouts before 2026. |
By Annalee Armstrong Fierce 15 is here! Nominations are open now in search of the best and brightest in biotech. |
Sponsored by MindMed Generalized anxiety disorder afflicts millions however, the latest treatment was approved in 2007. Now MindMed is advancing a new treatment paradigm. |
By Max Bayer Lykos Therapeutics’ MDMA-assisted therapy is charting yet another first in the psychedelic field: an FDA advisory meeting. |
By Gabrielle Masson Vertex Pharmaceuticals is ahead of schedule, filing a new drug application for its next-gen cystic fibrosis (CF) treatment, dubbed vanza triple. |
By Nick Paul Taylor Calliditas Therapeutics had a typical to-do list for its midphase head and neck cancer study. Step one, show the molecule shrinks tumors. Step two, look for early evidence of effect on survival. |
By Helen Floersh A personalized mRNA-based cancer vaccine for glioblastoma with an “onion-like” delivery mechanism appears to prolong survival both in dogs and in humans, the results of a small study suggest. |
By Gabrielle Masson,Annalee Armstrong,Max Bayer Welcome to Fierce Biotech's Fundraising Tracker, 2024's version. |
By Paige Minemyer Employers are in a strong position to lead the charge in changing the conversation around obesity care, according to a new report from the Milken Institute. |
By Conor Hale Outset Medical has resumed distributing its portable dialysis machine after halting sales last summer, now that it’s obtained a necessary green light from the FDA. |
By Fraiser Kansteiner As of mid-April, Vertex said it had collected 5 patients' cells for eventual treatment with sickle cell disease therapy Casgevy. That puts Vertex ahead of its gene therapy rival bluebird bio, which recently said it had collected just one patient's cells for its own SCD treatment Lyfgenia. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," we're diving into the details of the spree of big-money biopharma deals in 2023 and examining what that means for this year. |
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| WhitepaperPrecision collection of cell therapy source material doesn’t happen by chance. Our new whitepaper illuminates the science and strategies for successful apheresis. Sponsored by: Comprehensive Cell Solutions |
| WhitepaperLearn how Specifica’s in vitro antibody discovery platform can deliver better antibodies than traditional immunization approaches. Sponsored by: Specifica, a Q2 Solutions company |
| WhitepaperThis paper defines “digital companions” in biopharma, explores their value from the patient & company perspectives, & outlines a process for successfully fielding a new digital companion. Presented by: Blue Matter, strategic consultants in the life sciences |
| WhitepaperExplore the complex considerations of vaccine development for influenza and COVID-19, including the challenges posed by viral evolution and the importance of ongoing research in this paper by vaccine expert, Dr. Lisa Kierstead. Sponsored by: PPD®️ Laboratory Services |
| eBookTo make every rare disease trial count, we design patient-centric, relevant strategies for sponsors and caregivers to produce impactful results every time. Sponsored by: Emmes Company |
| WhitepaperDiscover the secrets behind successful patient engagement Sponsored by: ProofPilot |
| WhitepaperAntibody biomarkers are redefining precision medicine, from diagnosing diseases earlier to stratifying patients – download your FREE white paper today! Sponsored by: Sengenics Corporation LLC |
| WhitepaperThe use of prefilled syringes to administer biotherapeutics is beginning to gain traction because they offer a range of stability, efficacy, and patient safety benefits. Download this white paper to learn how Lonza has developed a novel workflow to ensure confidence regarding functionality in PFS and autoinjectors. Presented by Lonza |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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