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CSL Vifor proposes campaign to undo messaging about safety profile of rival product

Fierce Pharma

CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safe | CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safety of a rival product, the European Commission (EC) said.

Safety 147
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Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings

Fierce Pharma

Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. . | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Instead, it's adjusted the wording of a proposed boxed warning.

Safety 266
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Novo Nordisk, Eli Lilly face scrutiny from EU's drug regulator over GLP-1 safety

Fierce Pharma

The EMA is scrutinizing GLP-1s, raising a safety signal about the risk that drugs from Novo Nordisk, Eli Lilly and other companies could cause cancer.

Safety 308
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Workforce Trends in Pharma & Psychological Safety

PharmExec

Rebekah Martin, senior VP of reward, inclusion, and talent acquisition at AstraZeneca, discusses workforce trends in pharma and fostering an environment for psychological safety in this Pharmaceutical Executive Podcast video.

Safety 52
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Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

MedCity News

The post Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug appeared first on MedCity News. The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia.

Safety 109
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Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety

Fierce Pharma

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety aliu Wed, 05/17/2023 - 12:29

Safety 271
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CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices

Fierce Pharma

CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices. Tue, 01/17/2023 - 11:49.

Safety 328