Pharmaceutical Technology

JULY 22, 2025

It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension while we address any questions that FDA may have and complete the Elevidys label supplement process.”

Insurance Coverage and Processing

Pharmaceutical Technology

JUNE 16, 2025

By GlobalData Learn more about Strategic Intelligence Corwin added that Elevidys’s label will likely be updated to reflect the risk of ALF. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. For more information relating to our privacy practices, we invite you to review our privacy policy.

Insurance Coverage and Processing

pharmaphorum

JULY 7, 2025

Skip to main content Monday 7 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

Insurance Coverage and Processing

Pharmaceutical Technology

JULY 17, 2025

July 17, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The announcement included updates on Elevidys’ label changes for Duchenne muscular dystrophy treatment. It also announced an update regarding its Elevidys label changes for Duchenne muscular dystrophy (DMD) treatment. Credit: luchschenF/Shutterstock.com.

Insurance Coverage and Processing

Pharmaceutical Technology

JUNE 13, 2025

Vaccines under political pressure Whilst the label expansion reflects an easing in regulatory tension surrounding mRNA vaccines under the Trump administration, FDA approval does not automatically mean shots enter national immunisation schedules. It also gained FDA approval a year before mRESVIA, giving it first to market advantage.

Vaccines

Putting Patients First Blog

SEPTEMBER 3, 2024

The NHC appreciates CMS’ efforts to gather patient-centered data as part of this ICR and its commitment to making the process more relevant for patients and patient organizations. While we acknowledge these improvements, it is important to note that some aspects of the data collection process may remain challenging.

Drug Pricing

pharmaphorum

AUGUST 31, 2021

ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. Their efforts pave the way for others, who can learn from the successes and failures to inform their own ECAs. This can require new processes, technologies and an organisation mind shift.”.

Insurance Coverage and Processing

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In the US, most private health insurers have been slow to cover the cost of anti-obesity therapeutics.

Insurance Coverage and Processing

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In the US, most private health insurers have been slow to cover the cost of anti-obesity therapeutics.

Insurance Coverage and Processing

FADIC

OCTOBER 24, 2023

FDA approval process The FDA regulates both OTC and prescription drugs, but in different ways. Prescription drugs have to go through the New Drug Application (NDA) process. The application includes submitting clinical drug trial data and information about the manufacturing process.

Health and Personal Care Stores

Putting Patients First Blog

JULY 2, 2024

We believe that patient-centric engagement is essential to ensure that the negotiation process leads to outcomes that genuinely benefit patients. Patient Engagement The NHC recognizes and commends CMS’ willingness to improve the listening sessions and the data submission processes. Improving the Data Collection (ICR) Process.

Drug Pricing

ID Stewardship

JUNE 6, 2023

We’ll dive into the many ways AI can assist pharmacists, from streamlining medication dispensing processes to enhancing patient education. Personalized Medication Recommendations : AI algorithms can process patient data, such as age, gender, medical conditions, and allergies, to generate tailored medication recommendations.

Insurance Coverage and Processing

Putting Patients First Blog

JANUARY 27, 2025

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.

Insurance Coverage and Processing

The Thyroid Pharmacist

JUNE 30, 2023

I have personally seen this medication change people’s lives and wanted to share some more information on it, in case you have hit a plateau in your healing journey. Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses. It’s a process and a journey, but it’s definitely worth it.

Compounding

Big Molecule Watch

AUGUST 25, 2023

Congress left Medicare drug pricing to the drug manufacturers, pharmacies, and insurance plan sponsors to determine, and expressly prohibited the government from “interfering” in those private price negotiations under the so-called “Non-Interference Clause” of the Medicare Modernization Act of 2003.

Drug Pricing