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    • Makena

Makena Newsletter
  • Insurer Denies Access To Drugs Granted Accelerated Approval By FDA 03 Feb 2025 14:15 GMT

    … bars coverage of FDA approved treatments until 18 months … the Medicaid Drug Rebate Program and cover all FDA-approved drugs, including … access to pharmaceuticals licensed under the FDA’s accelerated … Two of the three drugs, Makena and Aduhelm, are now …

  • District attorney wants New Year’s focus on drug and theft crimes 31 Jan 2025 20:34 GMT

    … strikes a balance with drug treatment and is consistent with … who then possess hard drugs like fentanyl, heroin and … participate in court-ordered drug treatment programs can avoid incarceration … funding for substance abuse treatment programs. —Makena Huey

  • Makena Wood balances excellence in the pool and classroom 30 Jan 2025 06:04 GMT

    … 29, 2025. USPORTS COMMUNICATIONS For Makena Wood, a student-athlete at … ultimate goal is to attend medical school and incorporate research into …

  • FDA’s Accelerated Approval Pathway Under Scrutiny for Key Drug Approvals 17 Jan 2025 23:08 GMT

    … Sarepta), and hydroxyprogesterone caproate (Makena; Covis Pharma Group), highlighting … trials are completed. The FDA’s Center for Drug … Medicare decided to restrict coverage of aducanumab to clinical trial … safe, and effective treatments for patients.1 With …

  • Government watchdog recommends tweaks to FDA accelerated approval program 16 Jan 2025 23:28 GMT

    … birth drug Makena. The OIG found that the FDA approved all three drugs despite … treatment. The approval then is contingent upon a confirmatory trial. But the FDA … for Covis’ Makena, which was approved in 2011, the FDA pulled back …

  • Watchdog flags flaws in FDA's fast-track drug approvals 16 Jan 2025 00:19 GMT

    … 's preterm birth prevention treatment, Makena.  The OIG report points to … the case of Aduhelm, where FDA records indicated only 13 meetings … provide faster access to drugs addressing unmet medical needs, has been criticized …

  • Federal watchdog cites concerns with FDA’s accelerated approval process 15 Jan 2025 16:38 GMT

    … waste money on ineffective treatments, according to a report … treatments and have patient advocates pushing the FDA to approve new medicines … with the reviews of Makena, a drug to reduce the risk … market, but its required trial to demonstrate clinical benefit …

  • Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs 15 Jan 2025 13:34 GMT

    … the FDA’s judgement in granting accelerated approval to certain medications. In … . The FDA pulled its approval of Covis’ preterm birth drug Makena in April … still commercial, though its confirmatory trial is delayed. “Eteplirsen was approved …

  • A biotech legend, pharma CEO, and two Trump admin vets walk into JPM Day 2 14 Jan 2025 23:57 GMT

    … newsletter. Stay tuned. A biotech legend’s advice Joe Edelman … Jr. might pose to vaccine confidence and the FDA, but thinks the … poses to the U.S. pharmaceutical industry. New details on what … 51, the recalled preterm birth drug Makena, and Biogen’s Aduhelm as …

  • Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says 14 Jan 2025 21:26 GMT

    … an Alzheimer’s treatment, and Makena, developed to ward … around transparency. While FDA records showed 13 … medical needs with novel treatments, it has faced intense scrutiny for allowing drugs … confirmatory trials were delayed for numerous drugs approved …

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