| Today’s Big NewsOct 18, 2023 |
| 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. |
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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 Conor Hale Those forecasts come alongside reports of $10.1 billion in sales for the third quarter—reflecting 13.8% growth among Abbott’s core segments. |
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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November 14-15, 2023 | Free Virtual Event The Fierce Diversity, Equity, and Inclusion Forum is back again this year and better than ever. We are collaborating with our Fierce Healthcare Editorial Team to expand the topics and audience for this exciting program across two days. Providing a wide range of strategies and best practices for pharma and biotech companies looking to improve their diversity efforts across all areas of their business. Save your seat now!
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By Kevin Dunleavy UCB is on an approval roll. Within hours of each other, the Brussels-based company has scored FDA green lights for plaque psoriasis treatment Bimzelx and for generalized myasthenia gravis (gMG) drug Zilbrysq. Not only that, the Zilbrysq endorsement is UCB’s second in the indication this year, coming on top of the FDA signing off on UCB’s Rystiggo in June. |
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 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 Andrea Park Shortcuts aren’t common in medicine, but BrainsWay may have found an effective one for treating major depressive disorder. |
By Fraiser Kansteiner As Johnson & Johnson and Legend Biotech have sought to grow the reach of their multiple myeloma CAR-T drug Carvykti since winning FDA approval last year, they've occasionally run into manufacturing pitfalls. Now, with an eye on a big market expansion, J&J is laying out the state of its cell therapy production writ large. |
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 Andrea Park Prolific medtech investor Vensana Capital’s next move is now evident. Literally: Evident Vascular, a startup incubated by the investor, has now exited stealth with plans to introduce an intravascular ultrasound (IVUS) platform enhanced by artificial intelligence technology. |
Fierce podcastsDon’t miss an episode |
| | 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. |
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Thursday, November 9, 2023 | 2pm ET / 11am PT Join us for this webinar to explore the transformative power of decentralized clinical trials. Learn how automation is reshaping the landscape of clinical development, empowering life sciences professionals to streamline processes, reduce costs, and accelerate drug development timelines. Register now.
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| 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 |
| WebinarEmbark 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 |
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