cafepharma · @cafepharma
12 followers · 94 posts · Server toot.communityQ1 claimed the highest number of trial starts in 2022 — AbbVie knocks down earnings forecast due to IPR&D charge — FDA forces unproven premature birth drug Makena off market -- See more on our front page news http://bit.ly/w28kSd #abbvie #researchanddevelopment #fda #makena #pretermbirth #clinicaltrials #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#abbvie #researchanddevelopment #FdA #makena #PretermBirth #clinicaltrials #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
Melody Schreiber · @m_scribe
872 followers · 1141 posts · Server newsie.socialIn the 12 years since Makena was fast-tracked by the FDA, about 350,000 patients received pricey injections to prevent premature birth, a major health issue facing children and families.
There was just one problem: there’s no evidence Makena actually works. My latest for @TheGuardian
https://www.theguardian.com/us-news/2023/mar/23/makena-premature-birth-drug-pulled-us-reaction
#Makena #FDA #PrematureBirth #PretermBirth #MedMastodon
#makena #FDA #prematurebirth #PretermBirth #MedMastodon
Poetry News · @haikubot
595 followers · 4609 posts · Server mastodon.cloud
Studies did show
Makena's effect was slow
F.D.A. rescinds permission
#fda #makena #pretermbirth #drugwithdrawal #haiku #poetry
https://www.nytimes.com/2023/03/07/health/preterm-birth-drug-makena-fda.html
#fda #makena #Pretermbirth #drugwithdrawal #haiku #poetry
Kevin Ault · @kevinault
203 followers · 269 posts · Server med-mastodon.com
"The #Makena story raises questions about the accelerated approval pathway’s implicit promise: approval can be provided on an expedited basis with the ability to quickly withdraw drugs that fail confirmatory trials."