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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 9, 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 Gabrielle Masson Novo Nordisk has penned a $600 million biobucks pact with Flagship-founded Metaphore Biotechnologies to develop up to two next-gen obesity treatments. |
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By Nick Paul Taylor Takeda has taken an ax to its clinical-phase pipeline, hacking off midphase programs and early-stage prospects as part of a push to focus on its most promising prospects. |
By Annalee Armstrong Phil Gregory’s new gig looks a whole lot like his old gig. It’s just that, under the umbrella of Regeneron, things have gotten a bit bigger. |
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 James Waldron Innovent has scored another phase 3 win for mazdutide, as the Eli Lilly drug showed its superiority to Trulicity when it came to glycemic control in patients with Type 2 diabetes. |
By Nick Paul Taylor The need to stretch strained bank balances has hit pipelines once again. Rallybio and Monopar are the latest biotechs to rethink their spending, respectively stopping preclinical investment and pivoting to radiopharmaceuticals to stretch limited resources. |
By Annalee Armstrong If a gene therapy is approved in the U.S., patients in Brazil can sue their government to get it cleared for use there. It’s why global regulators need to work together, the FDA’s Peter Marks, M.D., Ph.D., said at the American Society of Gene and Cell Therapy annual meeting Thursday in Baltimore. |
By Helen Floersh The U.S. FDA, the Environmental Protection Agency and the Department of Agriculture have answered the Biden administration’s call to design a plan to overhaul biotech regulations, with details on future policies for post-approval chemistry, manufacturing and controls changes, genome editing technologies and more. |
By Gabrielle Masson,Annalee Armstrong,Max Bayer Welcome to Fierce Biotech's Fundraising Tracker, 2024's version. |
By Helen Floersh Sponsors have struggled to improve diversity in clinical trials. Homing in on informed consent may be the key to changing that, with the welcome side effect of empowering patients to participate in their medical care. |
By Helen Floersh Ring Therapeutics revealed data at the 2024 American Society for Gene and Cell Therapy meeting showing that a viral vector based on the anellovirus can express genes in the retinas of primates and be dosed more than once, overcoming a major hurdle to the broader applications for gene therapies. |
By Zoey Becker Under the framework, hospitals, purchasers and generic drug makers could earn incentive payments after meeting new contracting and purchasing standards. The lawmakers proposed supply contracts with longer timelines, greater supply commitments and contingency deals with alternative manufacturers. |
By Dave Muoio The Catholic health giant said it detected "unusual activity" Wednesday and "immediately" activated remediation processes, including hiring a third-party cybersecurity firm. |
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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