European Pharmaceutical Review

DECEMBER 19, 2022

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. For this reason, a unique ‘abridged’ procedure was introduced to provide a specific regulatory pathway for biosimilars in the EU.

Medicine 52

Medicine Biopharma Safety Food 52

PM360

SEPTEMBER 28, 2022

Chrys Kokino has been involved in the biosimilars market prior to the first biosimilar being approved in Europe in 2006. Now, as the President of Accord BioPharma , the U.S. From that point in 2006 all the way to where we are currently today, there has been a very dramatic evolution of these products.

Competition 98

Competition Marketing Manufacturing Biopharma 98

Clarivate

NOVEMBER 10, 2022

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. In this article, we share how a sponsor partnered with Clarivate to incorporate COAs into clinical trials for alopecia areata. The regulatory landscape around COAs is fast evolving.

Patients 52

Patients Food and Drug Administration FDA Safety 52

Clarivate

NOVEMBER 13, 2023

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. Data and insights gleaned from these projects have most recently been presented at industry conferences and events, including ISPOR.

Patients 52

Patients Food and Drug Administration FDA Safety 52

pharmaphorum

AUGUST 4, 2022

This is due to the specialist nature of roles and the growth and diversification of biopharma, which requires an increasingly sophisticated and skilled workforce. In addition, she worked as head of inspectorate and licensing for the MHRA from 2004-2006. Training and development. She joined NSF in 2017. appeared first on.

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Recruitment Pharma Training Pharmaceutical manufacturing 92

Pharmaceutical Technology

AUGUST 26, 2008

“The inherent advantages of biopharma are that it allows you to pursue therapies against targets that are not small molecule therapies, for example by targeting protein-protein interactions and targeting GPCRs (G-protein coupled receptors),” he says. “Biotechnology has exploded across the industry. .”

Pharmaceutical 52

Pharmaceutical Manufacturing Biopharma Medicine 52