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
MP3•Episoder hjem
Manage episode 432118169 series 2877522
Innhold levert av Citeline. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Citeline eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.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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continue reading
1398 episoder
MP3•Episoder hjem
Manage episode 432118169 series 2877522
Innhold levert av Citeline. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Citeline eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.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 episoder
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