ePT--the Electronic Newsletter of Pharmaceutical Technology, May 10, 2012 - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

ePT--the Electronic Newsletter of Pharmaceutical Technology, May 10, 2012
News
FDA Issues Final Rule on Sterility Testing of Biologics
By Angie Drakulich
FDA issued a final rule on sterility testing on May 3, 2012, which amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. Many steps are changed or eliminated.
Sanofi Gains Regulatory Approval for Expansion at Site in Ireland
By Patricia Van Arnum
Sanofi has received FDA and EMA approval for expansion of fill and finish operations for alglucosidase alfa.
Abbott Reaches Settlement Agreement on Depakote
By Amy Ritter
Abbott Laboratories will pay $1.6 billion to settle outstanding issues concerning past sales and marketing practices for its neurologic medication, Depakote.
EFPIA Advances Medicines Verification Project
By Stephanie Sutton
The European Federation of Pharmaceutical Industries and Associations has formally adopted a memorandum of understanding with key partners for a harmonized, European system for medicines verification.
Week of May 7, 2012: Coherus BioSciences, Daiichi Sankyo Form Biosimilar Pact; Sandoz Agrees to Acquire Fougera Pharmaceuticals; and More
Coherus BioSciences, Daiichi Sankyo Form Biosimilar Pact; Sandoz Agrees to Acquire Fougera Pharmaceuticals; and More.

ADVERTISEMENT

LCGC E-mail Newsletters

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

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
25%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
11%
Regulatory compliance
36%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Click here