Menu
View Cart  

Recommended Products

Visit Store
Gmp-inspection-preparation-checklist-130x160

GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological-risk-eval-and-mngmnt-for-md-130x160

Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Events

View All
Oct 23

13th Annual FDA Inspections Summit

Oct 30

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

Oct 30

Understanding ISO 19011:2018: The Path to Better Medical Device System Audits

Nov 1

SOPs and Policies for the 21st Century: Why Less is More

Nov 1

Brexit and the Impact to Your Global Business Operations: What Life Sciences Companies Need…

Nov 7

FDA’s New Biosimilars Plan: CBER’s New Policy and the Impact on Pharmaceutical Stakeholders

Editor's Picks

View all
Clearancestamp_blue

Matrix Surgical’s OmniPore Implants Cleared for Marketing

The company expects to launch additional variants in early 2019.
Patentlaw

AbbVie, Novartis Reach Deal on Humira Biosimilar

AbbVie reported Humira sales of $18.4 billion in 2017.

FDA FAST-TRACKS GENITOPE'S MYVAX

KEYWORDS Drug Pipeline Alert
A A

Genitope has reported that the FDA has granted fast-track status to MyVax, a potential non-Hodgkin's lymphoma treatment. Genitope is investigating whether MyVax, a personalized immunotherapy, improves patients with follicular non-Hodgkin's lymphoma, or fNHL.

MyVax is currently in a Phase III pivotal trial involving stage 3/4 fNHL patients. Results from a Phase II trial showed nine of 21 patients remained progression-free up to 78 months post-chemotherapy.