This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
About a month after Eisai initiated a rolling FDA application for its subcutaneous form of Leqembi, the U.S. The FDA assigned the subcutaneous Leqembi application a Prescription Drug User Fee Act decision date of January 25, 2025. agency has accepted the filing. |
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.
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?
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.
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.
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
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.
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.
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.
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.
We organize all of the trending information in your field so you don't have to. Join 8,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content