Medicare Price Inflation Rebates Levied On 27 Part B Drugs In First Round; Pfizer Tops The List

Biden Administration releases first list of Part B drugs subject to inflation rebates; others to follow on quarterly basis. Medicare won’t invoice sponsors until 2025, but patients could see coinsurance reductions next month.

Penalties On Price Increases For Physician Administered Drugs • Source: Shutterstock

Pfizer Inc. has five of the 27 Part B drugs subject to Medicare price inflation rebates for the first time under the Inflation Reduction Act, according to a list compiled by the Centers for Medicare and Medicaid Services.

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Kiji CEO On EU HTA Regulation, Hospital Exemption & The Future Of ATMPs

 

Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.

Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

Proposed HHS Budget Would Eliminate Medicare Negotiation Program Start-Up Funding

 
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The preliminary budget document supports legislation clawing back funds appropriated for the program.

Industry Highlights Issues With EU HTA Regulation’s PICO Framework For Vaccines

 

Vaccine developers should be aware that the framework underpinning the new EU Health Technology Assessment (HTA) Regulation might not be suitable for immunizations, but actions from policymakers and industry could help mitigate some issues, a senior figure from GSK says.

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FDA Leadership Shuffle Continues: Lowell Zeta Returns As OPDP, OGD Leaders Depart

 

Lowell Zeta, a senior counselor at the FDA from 2020 to 2021, returns as deputy commissioner for strategic initiatives. The agency also names a new acting CIO and acting CVM director, but OGD's Ted Sherwood and OPDP's Catherine Gray retired.

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.