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RFK Jr looks to alter rare disease regulation by fast-tracking drug approvals

Pharmaceutical Technology

The approval process for cell and gene therapy candidates is tricky, however, given their high-cost and oft-debated benefit-risk ratio. RFK Jr did not question their importance, and acknowledged panellists’ calls for faster regulatory processes. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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NHC Comments on Negotiation Data Elements and Drug Price Negotiation Process for Initial Price Applicability Year 2027 under Sections 11001 and 11002 of the IRA ICR Forms

Putting Patients First Blog

The NHC appreciates CMS’ efforts to gather patient-centered data as part of this ICR and its commitment to making the process more relevant for patients and patient organizations. While we acknowledge these improvements, it is important to note that some aspects of the data collection process may remain challenging.

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Drug price negotiations: pCPA consulting on a Temporary Access Process (pTAP)

Pharma in Brief

CADTH Time-Limited Reimbursement Recommendations Starting in the fall of 2023, CADTH, which conducts health technology assessments ( HTAs ) to inform public insurers, will introduce time-limited reimbursement recommendations for certain drug products. Evidence-generation plans.

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Bolstering Health Technology Assessment With the Help of AI

Pharmaceutical Commerce

Artificial intelligence addresses key limitations of traditional health technology assessments—such as data gaps and time-intensive processes—through automation, real-time data integration, and advanced predictive modeling, leading to faster and more informed decisions. In order to automate and enhance these tasks, AI-driven NLP can assist.

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Is India capable of ensuring equitable access to biopharmaceuticals?

Express Pharma

To help financially weak citizens gain access to affordable healthcare, the Pradhan Mantri Jan Arogya Yojana (PMJAY) was launched in 2018, providing about 500 million Indians with a ₹5 lakh family health insurance cover that include coverage for 1,400 medical procedures as well as critical diseases like prostate cancer.

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FDA removes safety programme for CAR-T therapies to boost uptake

Pharmaceutical Technology

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. How will RFK Jr’s American dream for vaccines play out? This update also suggests we may not see REMS requirements for CD19 and BCMA autologous CAR-T cell therapies in the future,” the research note added.

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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027

Putting Patients First Blog

General Comments The NHC appreciates CMS’ commitment to actively engaging with stakeholders, including patients, consumer advocates, and health experts, in implementing the Medicare Drug Price Negotiation Program (DPNP). The NHC provides the following comments to CMS to improve on the steps it has already taken to date.