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Safety Risk Sinks Cargo Therapeutics’ Cancer Cell Therapy Prospect, Leading to 50% Staff Cut

MedCity News

The post Safety Risk Sinks Cargo Therapeutics Cancer Cell Therapy Prospect, Leading to 50% Staff Cut appeared first on MedCity News. Phase 2 data for Cargo Therapeutics CD22-targeting cell therapy show low durability and cases of a severe immune response, some that were classified as grade 4 or 5 serious adverse events.

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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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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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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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Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal

MedCity News

tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring. The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury.

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