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Keeping Track: Tpoxx Wins Green Light For Smallpox, Submissions Galore, And A Broader Approval For Xtandi

Executive Summary

The latest drug development news and highlights from our US FDA Performance Tracker.

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Monkeypox: US Gov’t Leaders Say Tpoxx Needs Randomized Control Trial Before Treatment For All

Media reports have emphasized the public’s frustration with gaining access to Tpoxx, an antiviral that may help treat monkeypox. But top officials at FDA, CDC and NIH defend the need to study the drug more first, even as they note they are making expanded access easier.

Deal Watch: Amgen Taps Plexium's Expertise In Targeted Protein Degradation

Mersana will help J&J develop antibody-drug conjugates against three targets, while AstraZeneca out-licenses a candidate for peripheral artery disease to Regio.

ASCO In Brief: US FDA Looks At Safety Outcomes By Performance Status, Metastasis-Free Survival In Elderly Men

Exploratory analysis suggests cancer patients with poorer baseline status can be enrolled in clinical trials without endangering registration prospects for the drug. Older prostate cancer patients derived a similar benefit to younger patients in metastasis-free survival with androgen-receptor inhibitors, FDA researchers found in an exploratory subgroup analysis of three registrational trials.

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