Remove tag clinical-decision-support
article thumbnail

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

pharmaphorum

That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s since 2003, which it says has “no evidentiary basis.” Broad label questioned.

FDA 98
article thumbnail

Can gene therapies for haemophilia defend their high price tags?

Pharmaceutical Technology

On November 2, the Institute for Clinical and Economic Review (ICER) released its updated evidence aimed at measuring the clinical effectiveness and cost of the two haemophilia gene therapies. An approval decision on the gene therapy, also known as EtranaDez, is expected by the end of this month. million price tag.

FDA 111
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Biogen updates on its confirmatory Aduhelm trial

pharmaphorum

Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.

FDA 52
article thumbnail

Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go

pharmaphorum

The FDA awarded a fast-track designation to lecanemab in December and has also given the drug breakthrough tag as a treatment for early-stage Alzheimer’s, and Biogen and Eisai will be hoping the drug can sidestep the controversy that engulfed Aduhelm from the moment it was approved.

FDA 40
article thumbnail

PharmDs – Crucial to Chronic Care Management Services: A Doctor’s Perspective

PharmD Live

A team pharmacist can save time and provide confidence in decision-making because of their expertise and experience. 88% report that their EHR produces clinical benefits for the practice. The variety of circumstances that can be defined as chronic care management supports the prospect of having coordination centered around medication.

article thumbnail

Conjugation and Labeling of Molecules: A Burgeoning Approach in Therapeutics Development and Molecular Imaging

Roots Analysis

These molecules can be conjugated with various modalities, such as haptens, enzymes, isotopes, fluorescent tags, carrier proteins, polymers, particle conjugates and photoreactive molecules. Bioconjugation is a subset of conjugation where one of the entity is a biomolecule, such as protein or an antibody.

article thumbnail

Putting complex medicines under the microscope

European Pharmaceutical Review

The biological characterisation of complex medicines is fundamental to translate these novel therapeutics and associated drug delivery technologies into the clinic; to understand the interplay with biological systems and to evaluate new formulations?. Improved analysis pre-clinically via advanced light microscopy could help.