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CAR-T therapies have transformed treatment for certain hematological malignancies, but their use is limited. Ongoing research seeks to improve safety, efficacy, and lower costs, expanding their application. To learn more, download our white paper. 
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Today’s Big NewsSep 19, 2024 |
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Register for this complimentary symposium in Cambridge, MA to see researchers from academia, industry and BioIVT present on the new ICH M12 guidance and a variety of trending topics... Learn More >> 
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| By Nick Paul Taylor Vanda Pharmaceuticals has failed to persuade the FDA to approve its gastroparesis candidate on the strength of a phase 3 trial that missed its primary endpoint. The biotech came out swinging after the blow, accusing the FDA of sending a complete response letter that generally disregarded the evidence. |
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By Gabrielle Masson GC Therapeutics has entered gameplay with the mission of unlocking a new generation of cell therapies, uploading with $75 million for its “plug-and-play” tech developed in the lab of—and with cells from—George Church, Ph.D. |
By James Waldron The fall flurry of biotech IPOs shows no signs of abating, with Upstream Bio becoming the latest company to express an intention to go public. |
Sponsored by Avacare Clinical Research Network With intricate protocols and shifting regulatory demands, it’s more difficult than ever to find and keep participants, as well as gather reliable data. |
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Create an optimal path to the clinic that best suits your molecule and critical milestones. We now offer a full suite of integrated drug substance/drug product DNA-to-IND programs to accelerate any molecule type to the clinic. Download our white papers to learn more about our tailored CMC strategies. 
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By Nick Paul Taylor Achilles Therapeutics has torn up its strategy. The British biotech is stopping work on its clinical-phase cell therapy, looking into deals with groups working on other modalities and preparing to lay off staff. |
By James Waldron Basilea Pharmaceutica’s work developing new antifungals has received a significant boost from the U.S. Department of Health and Human Services, which has signed off on up to $268 million of funding to the company over more than a decade. |
By Darren Incorvaia With COVID-19 still spreading and mpox emerging as a public health emergency of international concern, the National Institutes of Health is upping preparations for future pandemics. |
By Dave Muoio The drugmaker had said it plans to require DSH covered entities obtain their drug discounts by submitting for a rebate after dispensing. |
By Conor Hale GE HealthCare’s recently acquired MIM Software division has secured an FDA clearance for a tool to help quantify the density of amyloid plaque in the brains of people with Alzheimer’s disease. |
By Joseph Keenan Gavi, the Vaccine Alliance and the U.K. government ordered a combined 650,000 doses of Bavarian Nordic’s Jynneos mpox vaccine just days after the Danish drugmaker announced it would focus its resources to produce as many as 2 million doses by the end of 2024. |
By Fraiser Kansteiner Earlier this month, Granules was slapped with a Form 483 following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept. 6. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more. |
Fierce podcasts Don’t miss an episode |
| In this week's episode of "Podnosis," we're diving into the healthcare topics employers are watching most closely. |
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On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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