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FDA head Califf on tighter accelerated approvals and lower drug prices at JP Morgan

Pharmaceutical Technology

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said. That leaves three years for pharma companies to prepare.

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Orphan drugs’ financial success raises questions

pharmaphorum

Evaluate Pharma’s recent Orphan Drug Report subtitled its overview of the market ‘Niche no longer.’ This is based on the relative success orphan drugs have achieved, in terms of the number of approvals and the sales figures achieved for this area.

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NHC Comments on IRA Guidance Response

Putting Patients First Blog

Driven by the work of the Food and Drug Administration on patient-focused drug development (PFDD), many companies in the biopharmaceutical community have devoted significant resources to better understand patient populations and are working to bring to market products that best suit their needs. Sincerely, Randall L.

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August 2023 Newsletter

Safe Biologics

ASBM Statement on Announcement of Medicare Drug Price-Setting List On August 29th, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed into law last year.

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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.