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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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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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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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Safety Risks and FDA Hold Lead Gilead to Stop Work on Drug in Blood Cancers

MedCity News

Gilead Sciences said an independent review of interim Phase 3 data found the immunotherapy, magrolimab, led to a higher risk of death. Though Gilead is discontinuing further development of the drug in blood cancers, a review is ongoing in solid tumors.

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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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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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Hetero Labs Limited-Walk-In Interviews for EHS- Process Safety Management/ Process Safety Lab On 24th Sept’ 2022

Pharma Pathway

Hetero Labs Limited-Walk-In Interviews for EHS- Process Safety Management/ Process Safety Lab On 24th Sept’ 2022. HETERO is one of the India’s leading generic pharmaceutical companies and is one of the world’s largest producer of anti-retroviral drugs for the treatment of HIV/AIDS. Job Description. Experience: Freshers.

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