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Stage 1 of the FDA’s LDT phaseout policy is fast approaching and will require strict adherence to the corrections and removals process. Remain compliant and safeguard public health – download our guide for the 7-step overview.
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Today’s Big NewsDec 10, 2024 |
| By Nick Paul Taylor BioNTech reported an 18-month overall survival rate of 69.7%, beating the cross-trial benchmark and supporting use in a broader population. |
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By James Waldron Lava Therapeutics has jettisoned its only wholly owned clinical-stage asset after the blood cancer drug “did not reach Lava’s internal benchmarks.” |
By James Waldron GSK has handed over $45 million upfront to fellow London, U.K.-based firm Relation to help the pharma identify new targets for fibrotic diseases and osteoarthritis. |
Sponsored by NVIDIA For all the consumer-facing headlines of generative AI’s healthcare failures—some less serious, others more troubling—a contrast is unfolding in the greater pharma and biotech universe. |
By Nick Paul Taylor NewAmsterdam is singing data from its Broadway heart disease trial, hailing another phase 3 win for its cholesterol-busting candidate. And, having struggled to wow investors with earlier data, the biotech sweetened its latest pitch with early suggestions that the molecule improves cardiovascular outcomes. |
By James Waldron CervoMed’s ex-Vertex drug has failed to reduce the severity of patients’ dementia in a phase 2 trial, halting plans for a late-stage study. |
By Darren Incorvaia After a data monitoring committee found that the RELIANCE II study of REL-1017 is unlikely to hit its primary endpoint, Relmada Therapeutics is scrapping both the RELIANCE II and Relight phase 3 trials of REL-1017 in major depressive disorder, the company announced on Dec. 9. |
By Gabrielle Masson,Annalee Armstrong,Darren Incorvaia,Max Bayer Welcome to Fierce Biotech's Fundraising Tracker, 2024's version. |
By Gabrielle Masson The layoffs will allow Belharra to extend its cash runway “to achieve key inflection points while alleviating capital raise pressures, particularly given the persistent uncertainties and fluctuations of the funding environment,” a spokesperson told Fierce Biotech. |
By Paige Minemyer The New York Police Department confirmed that there is a man in custody in central Pennsylvania in connection with the shooting death of UnitedHealthcare CEO Brian Thompson. |
By Zoey Becker The share buyback program comes after a recent $5 billion buyback campaign the company completed during the current quarter. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," we explore the biotech IPO market rebound and ask: Is the momentum here to stay? |
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| WhitepaperWe interviewed 14 R&D biopharma leaders on the critical success factors for building a Best Practice R&D organization. This report shares what we learned. Presented by Blue Matter, strategic consultants in the life sciences |
| WhitepaperExplore the robust cross-platform agreement between scRNA-seq and bulk RNA-seq, ensuring consistent and reproducible data on immune cell presence. Sponsored by: IQVIA Laboratories |
| 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 |
| WhitepaperLearn how to evaluate quality documentation to help you select the right raw materials at early decision points for your cell-based manufacturing processes. Presented by: Thermo Fisher Scientific |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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