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STAT+: Pharmalittle: FDA approves Pfizer’s RSV vaccine for newborns; Boehringer sues over IRA

STAT

The Food and Drug Administration approved a Pfizer vaccine that aims to protect newborns against RSV by vaccinating pregnant people, STAT tells us. The vaccine, marketed as Abrysvo, previously won approval for adults over the age of 60. Continue to STAT+ to read the full story…

Vaccines 233
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NHC Provides Input on Patient Engagement in Medicare Drug Price Negotiations

Putting Patients First Blog

NHC Provides Input on Patient Engagement in Medicare Drug Price Negotiations September 20, 2024 By: Allen Pinn, Coordinator, Policy August 16 marked two years since the Inflation Reduction Act (IRA) was signed into law. Earlier this year CMS released draft guidance for Initial Payment Applicability Year (IPAY) 2027.

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug.

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STAT+: Budget negotiations heat up as ACA subsidy extension, BIOSECURE get dropped

STAT

  Democrats floated the idea of extending the subsidies through 2026 in a year-end deal, and paying for it with a budgetary maneuver that would theoretically extend budget cuts that haven’t actually been implemented, as my colleague Rachel Cohrs Zhang reported. million people would lose coverage annually without the tax credits. 

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Medicare Price “Negotiations” Will Jeopardize Patient Access to New Medicines, Result in Worse Health Outcomes

Safe Biologics

September 11, 2023 The Centers for Medicare & Medicaid Services (CMS) recently announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed in to law last year. 1] 90% of new cancer drugs are available in the U.S.