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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair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

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NHC Submits Comments to CMS RE CY 2026 Policy & Technical Changes to MA and Part D Proposed Rule

Putting Patients First Blog

Coverage of Anti-Obesity Medications (AOMs) The NHC applauds CMS for aligning with the medical community and proposing to recognize obesity as a chronic disease and allow Medicare Part D coverage for AOMs. Below, we provide detailed comments and recommendations on key provisions of the proposed rule.

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

Pharmaceutical Technology

It limits the access of approved drugs to certain hospitals and clinics that had to be specially certified for therapy administration and have access to anti-inflammatory medication. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. How will RFK Jr’s American dream for vaccines play out?

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AbbVie buys $2.1bn Capstan, adding new in vivo CAR-T to pipeline

Pharmaceutical Technology

AbbVie’s purchase comes just a few days after the US Food and Drug Administration (FDA) removed an access barrier for currently approved CAR-T therapies, regarded as a boost to the sector’s outlook. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Building Intelligent Pharma Supply Chain Management with Real-World Data

Pharmaceutical Commerce

Intelligent medication management systems using RWD help hospitals forecast demand, respond to crises, and minimize medication expiration and loss, ultimately improving patient care and operational efficiency. The FDA oversees over 23,000 prescription drug products approved for marketing in the US 1 and ultimately, an estimated 361.3

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Medicaid’s Role in the CGT Sector

Pharmaceutical Commerce

1 There are specific diseases—including hemophilia and sickle cell disease (SCD)—that are more widespread in groups enrolled in Medicaid than commercially insured individuals, due to the program’s concentration on children, disabled adults, and those families financially impacted by treatment costs. of average manufacturer price.