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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 10, 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 Nick Paul Taylor MacroGenics’ safety woes have followed into phase 2. Having dialed down the dose in response to early-phase data, the biotech's stock cratered after reporting five deaths alongside an over 50% rate of grade 3 or worse adverse events. |
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By Annalee Armstrong Linda Burkly, Ph.D., was 37 years into a career at Biogen when Editas CEO Gilmore O’Neill—himself an alum of the neurological disease-focused big biotech—came knocking. |
By Max Bayer The FDA needs a few more weeks to decide the fate of Moderna's RSV vaccine, the company announced. A decision is now slated for the end of May, as opposed to May 12. |
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 It appears that Sanofi’s loss is Shionogi’s gain. Five months after the Federal Trade Commission scuttled Sanofi’s attempt to acquire Maze Therapeutics’ Pompe disease program, Japan’s Shionogi has scooped up the asset. |
By Max Bayer,Gabrielle Masson Sanofi's CSO has left the company amid a global R&D restructuring. Pfizer tags longtime Citi analyst for C-suite-level strategy role. Acelyrin's found CEO shocking leaves. |
By Gabrielle Masson,Max Bayer We really didn't want to have to create another Layoff Tracker this year. But here we are, launching the third annual iteration tracking biopharma layoffs. |
By Zoey Becker In a multi-year overhaul, the Japanese drugmaker plans to prioritize "organizational agility," procurement savings and tech efficiencies. It's all part of an effort to boost profit margins. |
By Ayla Ellison,Fraiser Kansteiner This week’s episode of “The Top Line,” kicks off a series diving into the latest advancements in cell and gene therapy manufacturing. |
By Heather Landi The U.S. Department of Justice announced Thursday it has established a new task force to take on healthcare monopolies and collusion. |
By Angus Liu Takeda launched a restructuring to achieve “organizational simplicity.” Innovent and Eli Lilly's GLP-1R/GCGR dual agonist notched a second positive phase 3 readout. A BIO survey of biopharma companies indicated that a sudden break-off from Chinese CDMOs could harm millions of patients. And more. |
Fierce podcastsDon’t miss an episode |
| This week’s episode of “The Top Line,” kicks off a series diving into the latest advancements in cell and gene therapy manufacturing. |
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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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