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J&J’s Zytiga Secures Survival Claim For Early Metastatic Prostate Cancer

 
• By Emily Hayes

Labeling now indicates a statistically significant 19% reduction in risk of death for Zytiga in chemo-naïve metastatic prostate cancer, similar to the 23% reduction just reported in long-term analysis of Medivation/Astellas’ competing Xtandi in the same population.

Johnson & Johnson’s prostate cancer drug Zytiga (abiraterone) now has a label that reflects a statistically significant overall survival benefit in the important earlier-stage population of chemotherapy-naïve metastatic prostate cancer patients.

FDA approved a new label for the androgen receptor inhibitor when used with prednisone citing this advantage in chemo-naïve metastatic...

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Titanium Dioxide Stays: EU Decides Not To Pull Plug On Widely Used Excipient

 
• By Neena Brizmohun

While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.

Plans For EU Biotech Act Shift Up A Gear

 
• By Eliza Slawther

Companies have until early November to respond to a public consultation from the European Commission on its planned Biotech Act, which it hopes will help unleash the potential of small and midsize enterprises in the bloc.

AI In Clinical Research: Benefits Across The Board, But ‘Nirvana’ Still Out Of Reach

 
• By Vibha Sharma

Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.