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Part B Demo Concerns Unite Policy Experts Across Political Spectrum

 
• By Cathy Kelly

Former Democratic congressional staffers agree with Republican health policy experts there is little to like about the proposed Medicare Part B drug payment demonstration.

The Medicare Part B drug payment demonstration proposed by the Centers for Medicare and Medicaid Services is troubling to health care policy experts across the political spectrum, based on comments at the recent National Comprehensive Cancer Network annual conference.

During a panel discussion on “cancer care during an election year,” two former Democratic health staffers who were important contributors...

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More from United States

COVID-19 Vaccine Studies On Spike Protein, Coadministration Reflect New US FDA Paradigm

 
• By Sue Sutter and Sarah Karlin-Smith

CBER Director Vinay Prasad wants the American public’s concerns about a possible link between spike protein and post-vaccination syndrome answered, while also demanding larger immunogenicity studies and new pragmatic trials to support coadministration with other vaccines.

US FDA Upheaval Forces User Fee Talks To Begin Later Than Usual

 
• By Derrick Gingery

The fall start of PDUFA and GDUFA negotiations could impact the agreement review process and other parts of the schedule intended to ensure it reaches Congress on time.

Vanda Slams US FDA ‘Generic Bias,’ Again Seeks To Undo Hetlioz ANDA Approvals

 
• By Dave Wallace

In its latest attempt to curtail generic versions of Hetlioz, Vanda Pharmaceuticals asked FDA Commissioner Martin Makary to reverse a previous agency decision upholding two ANDA approvals, claiming an “unacceptable culture of bias toward approving generic drugs” at the agency.

Pink Sheet Podcast: US FDA Changes COVID-19 Vaccine Labeling, Reimbursement Confusion Rises

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

More from North America

Project Orbis: 2025 Shaping Up To Be A Strong Year For Canadian Approvals

 
• By Eliza Slawther

Health Canada has approved four new drugs and 12 label variations so far this year via Project Orbis, a combined figure that already exceeds the annual approval figures for the two previous years. The agency explains the factors that impact annual approvals and highlights the pathway’s benefits.

US FDA’s ARIA Analysis Adds Earlier Scan To Biogen/Eisai Leqembi Label

 
• By Bridget Silverman

Six deaths early in treatment inspired a new safety requirement for Biogen/Eisai’s Leqembi to promote early identification of patients affected by the well-known risk of amyloid-related imaging abnormalities with edema (ARIA-E).

COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA’s Prasad

 
• By Sue Sutter

The CBER director rejected Pfizer’s assertions that pediatric dosing gaps, supply constraints and comparative mRNA content justify keeping the vaccine under emergency use authorization for younger children.