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FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe

Fierce Pharma

As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning. |

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Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

MedCity News

But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder. The post Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug appeared first on MedCity News.

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J.P. Morgan Leads $100M Financing for Startup’s R&D of Covalent Biologic Drugs for Cancer

MedCity News

With cancer as its initial focus, the startup contends its approach could offer safety and efficacy advantages compared to currently available targeted therapies. Morgan Leads $100M Financing for Startup’s R&D of Covalent Biologic Drugs for Cancer appeared first on MedCity News. The post J.P.

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Antibiotic demonstrates non-inferiority to a leading gonorrhoea treatment

European Pharmaceutical Review

EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the efficacy and safety of gepotidacin to ceftriaxone plus azithromycin in uncomplicated urogenital gonorrhoea. GSK shared that the safety and tolerability profile of gepotidacin in this trial was consistent with data seen in Phase I and II trials.

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Commercial Drug Sourcing for Clinical Trials

Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others.

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European authorities recognised for leading medicine regulatory oversight

European Pharmaceutical Review

The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines ”.

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ECNP 2023: new esketamine NS safety data for depression

European Pharmaceutical Review

The Janssen Pharmaceutical Companies of Johnson & Johnson has revealed that according to new safety data, SPRAVATO ® (esketamine nasal spray [NS]) has demonstrated superior efficacy compared to quetiapine extended-release (Quetiapine XR) for treatment-resistant depression (TRD). There were 53.6 percent of quetiapine XR-treated patients.

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