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Mashup Score: 1US FDA Wants Advisory Committee Duty To Be ‘Enjoyable’ - 1 month(s) ago
Advisory committee reform efforts include streamlining the selection and onboarding processes, in part to understand that members often have other professional priorities, Principal Deputy Commissioner Namandjé Bumpus said.
Source: pink.citeline.comCategories: General Medicine News, Rare DiseaseTweet
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Mashup Score: 1Alzheimer’s And Surrogate Endpoints: FDA’s On A Case-By-Case Basis Per New Guidance - 2 month(s) ago
After Aduhelm and Leqembi rendered the 2018 guidance moot, FDA formally acknowledges the possibility of using surrogate endpoints for accelerated approval in Alzheimer’s in updated draft but says acceptability of the any endpoint will depend on details of specific therapeutic program.
Source: pink.citeline.comCategories: General Medicine News, Rare DiseaseTweet
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Mashup Score: 2
OCE Director Richard Pazdur was less sanguine, however, noting that while the Pepaxto withdrawal may have been faster than others, it still required more than 60 meetings to complete.
Source: pink.citeline.comCategories: General Medicine News, Rare DiseaseTweet
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Mashup Score: 3Aduhelm’s Post-Marketing Studies: At Least One More Data Dump Likely Required By NIH - 2 month(s) ago
Pulling the controversial Alzheimer’s drug’s BLA should not exempt Biogen from fulfilling ClinicalTrials.gov reporting requirements for two key studies, even if the research gets terminated, former head of the NIH data repository tells the Pink Sheet.
Source: pink.citeline.comCategories: General Medicine News, Rare DiseaseTweet
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Mashup Score: 1US FDA’s Congressional Education Becoming More Essential With Key Member Departures - 3 month(s) ago
Energy and Commerce Committee Chair Cathy McMorris Rodgers’ decision not to seek reelection may mean FDA officials must orient a new chair on their activities and priorities.
Source: pink.citeline.comCategories: General Medicine News, Rare DiseaseTweet
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Mashup Score: 1The Sudden Stop In US FDA Advisory Committees - 3 month(s) ago
US FDA has not had a new drug application focused advisory committee meeting in more than two months, and none are currently scheduled in 2024. After a blistering pace in the first half of 2023, FDA’s sudden slowdown in expert panels is perplexing.
Source: pink.citeline.comCategories: General Medicine News, Rare DiseaseTweet
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Mashup Score: 1Accelerated Approval: Sponsor Size No Excuse For Confirmatory Trial Delays, FDA Says - 5 month(s) ago
There is a greater commitment among larger, well-capitalized oncology companies to complete confirmatory trials, Oncology Center of Excellence Director Richard Pazdur says; smaller company approach of first getting accelerated approval and then using commercial proceeds to capitalize confirmatory trial is ‘unacceptable.’
Source: pink.citeline.comCategories: General Medicine News, Rare DiseaseTweet
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Mashup Score: 1Gene Editing: Exa-Cel Panel Review Raises Practical Concerns About Theoretical Risks - 6 month(s) ago
US FDA advisory committee members questioned how potential off-target effects with Vertex’s gene therapy for sickle cell disease should be conveyed to patients and families, and whether labeling should say anything about these theoretical risks.
Source: pink.citeline.comCategories: General Medicine News, Rare DiseaseTweet
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Mashup Score: 1
CBER Director Peter Marks said the US may have to consider whether to maintain its ban on the practice of creating embryos to include heritable genetic modifications if other countries allow the practice.
Source: pink.citeline.comCategories: General Medicine News, Rare DiseaseTweet
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Mashup Score: 1
US FDA is emphasizing the need to assess the effects of menopause on drug safety and efficacy as a continuation of the agency’s efforts to encourage clinical trial sponsors to look more systematically for differences in clinical trial subpopulations.
Source: pink.citeline.comCategories: General Medicine News, Rare DiseaseTweet
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