European Pharmaceutical Review

OCTOBER 17, 2024

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). Thus, ARS Pharmaceuticals anticipates approval by Q1 2025 in the UK and launch by summer 2025. What are the main advantages of EURneffy over similar treatments?

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Food and Drug Administration Medicine Consulting Food 121

Pharmacy Times

APRIL 16, 2024

The 5-in-1 meningococcal ABCWY vaccine candidate has an assigned Prescription Drug User Fee Act action date of February 14, 2025.

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Pharmacy Times

AUGUST 6, 2024

The drug also receives orphan drug designation for the treatment of pancreatic neuroendocrine tumors and a Prescription Drug User Fee Act target action date of April 3, 2025.

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Prescription FDA 37

Pharmaceutical Technology

JUNE 1, 2023

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

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PM360

AUGUST 9, 2022

billion in 2025. The combined solution enables health plans and self-insured employers to realize immediate pharmacy cost savings and near-term medical cost reductions by integrating Levrx’s plan-specific and real-time prescription insights into the Adhere Platform medication optimization offerings. from 2021 and reach $4.2

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Prescription Medical Patients Side effects 105

Copyright Clearance Center

DECEMBER 10, 2024

The Alliance launched its new industry benchmark report on the implementation of Identification of Medicinal Products (IDMP) standards, which are due to become mandatory across the EU, with the FDA likely to follow close behind. The Pistoia Alliance is now welcoming registrations for its next member conference in London, 25-26 March 2025.

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Prescription Patients FDA Safety 52

Nixon Gwilt Law

NOVEMBER 8, 2024

CMS issued its 2025 Medicare Physician Fee Schedule (the “2025 MPFS” or “Final Rule”) on November 1, 2024. The Final 2025 MPFS contains some modifications and clarifications to several elements of the original proposal released in July 2024 (the “Proposed Rule”), which we discussed in this earlier post.

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Clarivate

AUGUST 20, 2024

Moreover, the initial set of negotiated prices represents the first step of a process that eventually will reshape the pricing and reimbursement landscape for prescription drugs under Medicare as CMS gradually replaces private payers as the chief negotiating partner for some of the drug industry’s largest-selling treatments.

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Manufacturing Government Prescription Pharmaceutical manufacturing 52

Clarivate

OCTOBER 17, 2024

Since the government first created a Part D benefit with the Medicare Modernization Act of 2003 (MMA) , Democrats have agitated for greater governmental input into the cost of prescription drugs for Medicare beneficiaries. Such a change would sharply increase the number of people covered under this program.

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