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Sickle Cell Gene Therapy In Medicaid: CMMI Model As ‘Bandwidth Extender’ For Less Resourced States

 
• By Cathy Kelly and Sarah Karlin-Smith

Outcomes-based contract that federal government will negotiate with manufacturers on behalf of Medicaid programs might not be appealing to large states. Bluebird and Vertex can apply to the demonstration project this spring and negotiations would follow between May and November.

Working To Facilitate Access To High-Cost, Cutting Edge Therapy • Source: Shutterstock

The Center for Medicare and Medicaid Innovation’s new payment model for gene therapies for sickle cell disease in Medicaid got a cautious reception from bluebird bio and Vertex Pharmaceuticals Incorporated after it was announced on 30 January.

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

 
• By Eliza Slawther

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

 
• By Neena Brizmohun

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

 
• By Cathy Kelly

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

 
• By Eliza Slawther

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

 
• By Sue Sutter and Derrick Gingery

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

 
• By Michael McCaughan

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’

 
• By Eliza Slawther

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.