Search Results for Vertex

Showing 1 – 5

Continuous Manufacturing: Pfizer, Vertex, AstraZeneca and Others Weigh FDA Plans By Zachary Brennan - Published 04 October 2017

The US Food and Drug Administration (FDA) has been encouraging the adoption of continuous manufacturing techniques for years, and several companies recently offered the agency some suggestions to refine its work around the developing technology.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Manufacturing

Tags: continuous manufacturing, Pfizer, AAM, Vertex, AstraZeneca

FDA Allows First Switch From Batch to Continuous Manufacturing for HIV Drug By Zachary Brennan - Published 12 April 2016

The US Food and Drug Administration (FDA) for the first time in its history allowed a manufacturer to switch from the more antiquated batch manufacturing process to a continuous manufacturing process – a move that FDA is seeking to encourage among more pharmaceutical manufacturers.

Categories: News, US, FDA, Compliance, Drugs, Due Diligence, Manufacturing, Quality

Tags: continuous manufacturing, Janssen, Prezista, Vertex, batch manufacturing

'Misleading' Patient Perspective Smacked Down by FDA in Untitled Letter By Alexander Gaffney - Published 31 May 2012

Categories: FDA

Tags: Incivik, Untitled Letter, Vertex, Warning Letter Analysis, Hepatitis C, HCV, Latest News

Data Reporting Mistake Hits Vertex Pharmaceuticals' Stock By Alexander Gaffney - Published 29 May 2012

Tags: VX 809, VX 770, Kalydeco, Vertex, Reporting, analysis, Latest News, data

EMA Recommends Vertex's Cystic Fibrosis Drug Kalydeco By Alexander Gaffney - Published 25 May 2012

Categories: EMA

Tags: Orphan Product, Cystic Fibrosis, CF, VX 770, Kalydeco, Vertex, rare disease, Latest News, CHMP