News - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

News


Pharmaceutical Technology Europe
Volume 24, Issue 1

News bites

EMA–FDA joint inspections
The FDA and EMA are moving from "confidence-building to reliance upon" each other in a step-up in cooperation on GMP inspections; the latest move following 0completion of pilot projects this summer. The initiative will begin in January 2012.

Read more at: http://www.PharmTech.com/jointgmp

Merck resolves charges
Merck & Co. has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx. The charges relate to off-label marketing. Under the agreement, Merck will plead guilty to a misdemeanor for its illegal promotional activity and will pay a $321,636,000 criminal fine.

Read more at: http://www.PharmTech.com/vioxx

FDA decides Avastin fate
The breast cancer indication for Avastin has been revoked in the US after the FDA Commissioner concluded that the drug has not been shown to be safe and effective for this use. The drug will, however, remain on the US market as an approved treatment for certain types of colon, lung, kidney and brain cancer.

Read more at: http://www.PharmTech.com/fdaavastin

EC battles superbugs
The EC has unveiled an action plan against antimicrobial resistance, including provisions to promote R&D as well as the possibility of establishing fast-track procedures for marketing authorisations. Among other areas, the EC has highlighted the development of new antimicrobials for treatment as a priority.

Read more at: http://www.PharmTech.com/superbugs


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Source: Pharmaceutical Technology Europe,
Click here