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‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

MedCity News

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.

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Re-engineering proteins to develop novel immunotherapies

European Pharmaceutical Review

By re-engineering existing approaches that have already shown clinical promise, there is potential to bring further benefit to the patient community in its fight against cancer. Since then, several next-generation antibodies have been engineered with modifications that enable them to better engage with immune cells.

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US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. According to the interim efficacy data from a pre-specified patient cohort, a 5.4 In the trial, 1.9%

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Novavax’s Covid-19 vaccine gets Taiwan FDA EUA for use in adults

Pharmaceutical Technology

The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain. The vaccine showed an encouraging safety and tolerability profile in both trials. The post Novavax’s Covid-19 vaccine gets Taiwan FDA EUA for use in adults appeared first on Pharmaceutical Technology.

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ClearPoint Neuro Announces FDA Clearance for ClearPoint Maestro™ Brain Model

Legacy MEDSearch

This is a crucial first step in our path to make the Maestro Brain Model the ‘engine’ in our navigation system supporting multiple new applications in the future. Surface meshes of segmented anatomical regions will define safety zones and optimal trajectories for patient-specific laser ablations. Press Release by: ClearPoint Neuro.

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AI IN PHARMACEUTICAL MARKETING: Optimizing Automation and Expertise

PM360

The most prominent among them include: AI misinterpretation of critical information: As an example, a team might ask ChatGPT to answer a question, and the AI engine may deliver an impressive volume of information, while misaligning with the core business, leading to conclusions that are either overvalued or flat-out wrong.

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FDA accepts BLA for Pfizer’s haemophilia B gene therapy

Pharma Leaders

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec. Based on the safety and efficacy findings from the Phase III BENEGENE-2 study, the company made these filings.