Montgomery & Company (MoCo) is a weekly podcast and radio show hosted by two-time WNBA Champion and Co-Owner/Vice President of the Atlanta Dream, Renee Montgomery, in partnership with WABE Atlanta. Both insightful and compelling, MoCo features interviews with some of the world’s top athletes, entertainers, and innovators as well as roundtable discussions with Renee’s colleagues, friends, and family, about sports, culture and building generational wealth. Montgomery & Company: Sports, Cultu ...
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Drug Fix: August User Fee Goals, Oncology Trial Design Issues, EMA Review Changes
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Manage episode 432118169 series 2877522
Content provided by Citeline. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Citeline or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ro.player.fm/legal.
Pink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August (:34), a trial design issue that could ensnare BMS’ Opdivo along with AstraZeneca’s Imfinzi (10:11), and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews (33:14). More On These Topics From The Pink Sheet Dozen Novel Agents Dream Of August US FDA Approval: https://pink.citeline.com/PS155070/Dozen-Novel-Agents-Dream-Of-August-US-FDA-Approval BMS’s Opdivo May Be Next Casualty Of US FDA’s Perioperative Trial Redesign Push: https://pink.citeline.com/PS155056/BMSs-Opdivo-May-Be-Next-Casualty-Of-US-FDAs-Perioperative-Trial-Redesign-Push EU Pilot On Raw Data Analysis Shows Benefits For Streamlining Medicines Evaluation: https://pink.citeline.com/PS155059/EU-Pilot-On-Raw-Data-Analysis-Shows-Benefits-For-Streamlining-Medicines-Evaluation
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1398 episoade
MP3•Pagina episodului
Manage episode 432118169 series 2877522
Content provided by Citeline. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Citeline or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ro.player.fm/legal.
Pink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August (:34), a trial design issue that could ensnare BMS’ Opdivo along with AstraZeneca’s Imfinzi (10:11), and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews (33:14). More On These Topics From The Pink Sheet Dozen Novel Agents Dream Of August US FDA Approval: https://pink.citeline.com/PS155070/Dozen-Novel-Agents-Dream-Of-August-US-FDA-Approval BMS’s Opdivo May Be Next Casualty Of US FDA’s Perioperative Trial Redesign Push: https://pink.citeline.com/PS155056/BMSs-Opdivo-May-Be-Next-Casualty-Of-US-FDAs-Perioperative-Trial-Redesign-Push EU Pilot On Raw Data Analysis Shows Benefits For Streamlining Medicines Evaluation: https://pink.citeline.com/PS155059/EU-Pilot-On-Raw-Data-Analysis-Shows-Benefits-For-Streamlining-Medicines-Evaluation
…
continue reading
1398 episoade
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