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Navigating uncertainty: the future of vaccine oversight amid CDC firings

Pharmaceutical Technology

GlobalData Healthcare June 25, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Changes to ACIP could result in regulatory uncertainty for vaccine developers and manufacturers. Malone, an early mRNA pioneer, has made unfounded claims regarding the dangers of mRNA vaccines, which have sparked significant public backlash.

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Turning Reconciliation into a Revenue Growth Engine

Drug Topics

For instance, the MFP is expected to affect approximately 10 drugs in 2026, with the list expanding annually, potentially creating a $22,000 monthly financial impact for average retail pharmacies.

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GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? Robert Barrie July 14, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Broader label coverages for Pfizer and Moderna’s vaccines mean they have made in-roads into GSK’s RSV dominant market share. A decision by the FDA is expected in H1 2026.

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FDA approves KalVista’s Ekterly for hereditary angioedema

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? KalVista will receive an upfront payment of $11m, with an additional $11m contingent upon achieving a regulatory milestone anticipated by early 2026. In April 2025, KalVista Pharmaceuticals granted Kaken Pharmaceutical the commercialisation rights for sebetralstat in Japan.

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UK steps up with £1.25bn Gavi vaccine pledge as US funding disappears

Pharmaceutical Technology

The UK has confirmed its support for global vaccination by pledging £1.25bn to global vaccine group Gavi while the US will halt funding to the international organisation. The group had set a fundraising target of $11.9bn for its 2026-2030 budget. Credit: speedshutter Photography via Shutterstock.

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FDA to review MSD’s doravirine/islatravir NDA for HIV-1

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? A target action date of 28 April 2026 has been set under the Prescription Drug User Fee Act (PDUFA). Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma Formulate Faster.

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Ultragenyx receives complete response letter for UX111 BLA

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? While the CRL will delay the potential approval of UX111 to 2026, we are working with urgency to respond and resubmit.” We have been diligently responding to the recent CMC observations and our priority is to resolve them so that we can resubmit the BLA as soon as possible. “We