Remove tag standards-and-controls
article thumbnail

Upcoming sickle cell gene therapies cost effective at $2 million, says ICER

Pharmaceutical Technology

Although the findings in the report are only preliminary, they shed light at the considerations behind the high price tags of gene therapies. Although the findings in the report are only preliminary, they shed light at the considerations behind the high price tags of gene therapies.

FDA 59
article thumbnail

What can pharma marketing learn from other regulated industries?

pharmaphorum

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. Virtual connections. Engagement channels.

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

bluebird bio to split into oncology and gene therapy specialists

pharmaphorum

Late last year, bluebird’s shares tanked after the FDA laid out additional manufacturing standards for its lead gene therapy product, Lentiglobin, in sickle cell anaemia that could hold up filing until late 2022. million price tag. million price tag.

FDA 58
article thumbnail

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

pharmaphorum

In a statement on the approval, ICER said the view of many experts was that current evidence is simply not enough to support the use of aducanumab in Alzheimer’s patients, and the FDA had “moved the goalposts” by not holding Biogen’s drug to the standards of other therapies. Broad label questioned.

FDA 98
article thumbnail

Actualising the power of antibody-drug conjugates as cancer therapeutics

European Pharmaceutical Review

3 The linker is designed to have properties that physically connect the antibody and cytotoxic drug, and facilitate favourable pharmacokinetic behaviour in circulation, as well as controlled release of the cytotoxin once delivered. An ADC combines the specificity of an antibody and the potent power of an anti?cancer

article thumbnail

Hydrocodone acetaminophen alternatives: What can I take instead of hydrocodone acetaminophen?

The Checkup by Singlecare

Based on the response, opioids may warrant dose titrations as well as trials of different medications within the class to control pain. It is a personal experience, and access to pain management is a basic right. Lortab ( hydrocodone-acetaminophen ) is a type of opioid medication. What can I take in place of hydrocodone acetaminophen ?

Dosage 52
article thumbnail

Moving to component management & traceability: progress, barriers, and the way forward

pharmaphorum

Regulatory agencies are embracing standardized review processes (such as the FDA’s KASA project) that benefit from direct data collection and incorporate review metrics. While some narrative text is still required, auto-population of clinical data into tables eliminates the need for substantial quality control actions.