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Download our guide to learn how to navigate the complex European landscape and gain insights on how late-stage customization could make your European distribution simpler and more efficient. Download now.
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Today’s Big NewsOct 18, 2023 |
| By James Waldron Almost a month after FDA advisers delivered a near-unanimous rejection of BrainStorm Cell Therapeutics’ ALS drug, the biotech is looking to sit down with the regulator to map out the next steps. |
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By Gabrielle Masson Nkarta wants cell therapy to go beyond cancer and has been given the FDA green light to move forward with a CAR NK candidate in human trials for lupus—news that sent the company’s stock soaring 112%. |
By Nick Paul Taylor Ultimovacs has clawed back confidence in its cancer vaccine candidate. Having missed the primary goal earlier this year, the Norwegian biotech has hit back with data showing adding its vaccine to two Bristol Myers Squibb drugs improved survival in patients with cancer of the lung lining. |
Sponsored by Tanvex CDMO Reacting to the growth of biotherapeutics, Tanvex BioPharma USA, Inc., is set to launch Tanvex CDMO, a full-service CDMO specializing in mammalian- and microbial-derived biologics and biosimilars. |
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Best-in-class thermostability and excellent inhibitor tolerance deliver compatibility across a range of clinically relevant samples and superior results in pathogen detection assays. Lyophilization-friendly formats available. Learn more.
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By James Waldron Ovid Therapeutics has sold off part of the royalty rights to its Takeda-partnered seizure med in order to fund its operations into 2026. |
By Nick Paul Taylor Intellia Therapeutics has received the green light to study its in vivo CRISPR-based gene editing therapy in the U.S., positioning it to start a phase 3 trial of the Regeneron-partnered candidate by the end of the year. |
By Helen Floersh In a development made possible with the help of AI, a malaria drug appears to reverse bone loss from osteoporosis in mice. |
By Joseph Keenan CRO giant Icon is partnering with Saphetor, which specializes in large-scale identification and interpretation of human genetic variants, to develop new approaches for clinical trials focused on precision medicine and rare diseases. |
By Kevin Dunleavy The results are in for a phase 3 bladder cancer trial assessing the combination of Seagen and Astellas' Padcev, plus Merck's Keytruda, versus standard of care chemotherapy. The figures indicate that the combo can be transformative in the indication. |
By Ayla Ellison,Paige Minemyer In this week’s episode of “Podnosis,” we delve into how Humana is expanding its reach in senior-focused primary care and home health. Fierce Payer Senior Editor Paige Minemyer caught up with Sanjay Shetty, M.D., president of Humana’s CenterWell segment, to explore why the insurer is placing its bets on primary care and the strategies the company intends to use to achieve its growth ambitions. |
By Zoey Becker After the FDA requested more data in 2021, Ardelyx instead defended its drug's profile through two appeals and an advisory committee meeting. Now, the company can celebrate a long-awaited win. |
By Nick Paul Taylor Emergent BioSolutions is rushing to get the message out about its opioid overdose treatment Narcan, partnering with former NFL star Emmitt Smith to spread the word at college football tailgates. |
Fierce podcastsDon’t miss an episode |
| In this episode of "The Top Line," Fierce Biotech's Annalee Armstrong engages in a conversation with Howard Fillit, M.D., an expert in the field of Alzheimer's research and the co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation. They delve into the pioneering work being done in Alzheimer's research, discuss the latest breakthroughs, and explore the ongoing efforts to combat this complex disease. |
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Learn how to improve yield and reproducibility with advanced sample prep for a variety of multiomics use cases, especially for suboptimal biospecimens. See how to get quality results from complex samples thanks to key innovations in ultrasonication. Learn more.
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| Whitepaper From trial site feasibility and patient populations to data analysis, generative AI has the potential to revolutionize drug discovery and clinical trial recruitment at both the therapeutic area and indication level. Sponsored by: H1 |
| eBookLearn how to get better results from suboptimal biospecimens for NGS and protein analysis. Sponsored by: Covaris |
| WhitepaperAccelerate drug discovery with high-performance computing (HPC) powered by the cloud Sponsored By: AWS, NVIDIA, and Rescale |
| WhitepaperCell and gene therapy development has exploded, with Q4 2022 showing more FDA approvals than over the past five years combined.[1] Sponsored by: Thermo Fisher Scientific |
| WhitepaperUncover the keys to efficient bioprocessing, including how outsourcing quality management can reduce risk, save time and money, and expedite biologics development. Sponsored by: Thermo Scientific™ Production Chemicals and Services |
| Webinar Embark on an in-depth journey through the pivotal Make-Test-Decide Workflow, where collaboration and data-driven decisions play a paramount role in the intricate landscape of drug discovery. Watch now to learn how cloud implementation fosters accessibility and collaboration, revolutionizing research across locations and companies. Sponsored by: Revvity Signals |
| WhitepaperEconomic and regulatory factors are making biopharma supply chains more complex in the EU. This paper explores strategies that biopharma companies can use to better manage complexity, cost, and risk. Presented by: AIM, the supply chain leader for life science entrants and midsize life science companies |
| WhitepaperFrom Assay Development Through Large Molecule Development. Streamline your R&D workflows and gain valuable insights with our Biology Solutions Brochure. Download now to discover how to control your laboratory workflows across various assay techniques, modalities, and data types. Sponsored by: Revvity Signals |
| eBookEmulate in vivo biology with next-generation in vitro technology. Sponsored by: Emulate |
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