“While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,” Raghav Chari, the company’s chief innovation officer, said in a statement.
The drug Makena doesn’t reduce the risk of preterm birth, a study found, and the FDA recommended it be taken off the market. Its maker has refused.
MelodyPetersen But I thought big pharma loved and cared about us.
Last year, melodypetersen detailed how Covis and the companies that previously owned the rights to Makena profited by taking a cheap, decades-old medicine with questionable effectiveness and safety and securing FDA authorization for its use.
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Drug to Prevent Preterm Births to Be Pulled From MarketThe maker of Makena said it will stop selling the drug to prevent preterm births after a study couldn’t confirm the medicine worked Wtf are these things let out before we know this. Jesus f----- Christ Good, do aducanumab next. How did it get approved in the first place?
Herkunft: WSJ - 🏆 98. / 63 Weiterlesen »
Maker of preterm birth drug Makena to withdraw it from market | CNNThe maker of the drug Makena, which was approved more than a decade ago to reduce the risk of preterm birth, said Tuesday that it is moving to withdraw the medication from the market after a US Food and Administration panel said it is not effective. Now if they would have only done that with the Covid vaccines. Think of the lives they would have saved. The vaccine has also proven not to work against c19 but your not pulling that. Wonder why?
Herkunft: CNN - 🏆 4. / 95 Weiterlesen »
BioMarin’s stock falls after another company’s dwarfism drug moves into Phase 3 clinical trialsShares of BioMarin Pharmaceutical Inc. were down about 6.0% in premarket trading on Monday after BridgeBio Pharma Inc. shared positive Phase 2 clinical data...
Herkunft: MarketWatch - 🏆 3. / 97 Weiterlesen »