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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 8, 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 Max Bayer Sanofi CSO Frank Nestle is leaving the company, a spokesperson confirmed. He joined the French pharma in 2016. |
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By Gabrielle Masson A young boy with Duchenne muscular dystrophy participating in Pfizer’s phase 2 gene therapy trial has died, the pharma shared in a May 7 letter cited by nonprofit Parent Project Muscular Dystrophy. |
By Annalee Armstrong Accelerated approval—controversial, yes—but absolutely necessary for small, pre-revenue biotechs trying to find new treatments for small patient populations, the FDA’s Peter Marks, M.D., Ph.D., said Wednesday. |
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 Annalee Armstrong If your child is in a clinical trial for what could be a groundbreaking treatment to restore hearing, as a parent, you’re going to notice the changes before a clinical investigator ever does. That’s what happened for patient 1 in a phase 1/2 trial called CHORD. |
By Max Bayer Walking Fish Therapeutics has closed after failing to secure additional funding, CEO Rusty Williams confirmed. The company was working on engineered B-cells to treat rare diseases. |
By James Waldron Pharming Group has sawed off its gene therapy collaboration with Orchard Therapeutics, a decision that will see the end of a preclinical hereditary angioedema (HAE) program. |
By James Waldron Marinus Pharmaceuticals is implementing a raft of cost-cutting measures in the wake of last month's phase 3 struggles—including waving goodbye to a fifth of its workforce. |
By Nick Paul Taylor Compass Pathways has navigated to another successful midphase readout, linking its psilocybin therapy and psychological support to improvements in post-traumatic stress disorder in a small study. |
By Annalee Armstrong After Orchard Therapeutics’ gene therapy for a rare genetic disease was approved in March, Peter Marks, M.D., Ph.D., received a simple email from Commissioner Robert Califf, M.D. |
By Annalee Armstrong Fierce 15 is here! Nominations are open now in search of the best and brightest in biotech. |
By Helen Floersh Big Pharma veteran Jo Goodman is joining Celerion as vice president of bioanalytical services at the contract research organization’s Lincoln, Nebraska, lab. |
By Zoey Becker The topical gene therapy has pulled in nearly $100 million during its first three quarters on the U.S. market. Meanwhile, Vyjuvek is currently under review in Europe, and a filing in Japan is planned for later this year. |
By Kevin Dunleavy Once hailed as a landmark accomplishment and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European Medicines Agency (EMA). On Tuesday, the EMA said it had accepted a request from AZ and withdrawn the company’s marketing authorization for its COVID-19 shot Vaxzevria. |
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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