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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

Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers.

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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair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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How early planning leads to successful market access and drug launch in Europe

Pharmaceutical Technology

Launching a new drug can be a risky business, with regulatory approval no guarantee that private, commercial, and government-funded insurers will reimburse it. In Europe, the pricing and reimbursement (P&R) of pharmaceuticals is governed by individual member states.

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DoH and Children’s National Hospital link for cell and gene therapy

Pharmaceutical Technology

This alliance seeks to bolster clinical trial capabilities through improved regulatory processes and data governance. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. We may still continue to send you service-related and other non-promotional communications.

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Ultragenyx receives complete response letter for UX111 BLA

Pharmaceutical Technology

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma Formulate Faster. The company is confident that these concerns, which pertain to facilities and processes rather than product quality, can be promptly addressed.