Pharmaceutical Technology Europe - November 2012 - (Page 10)

BLOGS ABRIDGED Roche Under EMA Investigation Stephanie Sutton Earlier this year in June, Roche’s name hit the headlines after a pharmacovigilance inspection discovered around 80000 safety reports that had not been evaluated by the company to determine whether they should be reported as adverse drug reactions. Included in the reports were approximately 15161 deaths. Recently, the case accelerated as the European Medicines Agency launched an infringement procedure against Roche to investigate the alleged pharmacovigilance deficiencies. The procedure means that EMA will be able to investigate Roche within the legal framework of Europe’s Regulation (EC) No 658/2007, which concerns financial penalties. The case could mean fines or periodic penalty payments being imposed upon Roche if the company is found to have failed to comply with its pharmacovigilance obligations. EMA will report the outcomes of the investigation to the European Commission. http://blog.pharmtech.com/2012/10/23/roche-under-ema-investigation/ Third Quarter Revenues Wounded by Patent Expiries Adeline Siew As third quarter results were being released, we heard of several top drugmakers facing hard knocks from the fall off the patent cliff. Pharmaceutical news have been populated with headlines such as the following: Sanofi drops as major patent expiries take hold, Bristol-Myers results fall short as Plavix sales evaporate, AstraZeneca continues to see revenue decline, and Lilly revenues down as generics erode Zyprexa sales. French drugmaker, Sanofi, suffered net sales loss of EUR448 million as a result of generic competition, particularly with the loss of patent rights to its colorectal cancer drug, Eloxatin (oxaliplatin) in the United States this August. Sanofi’s share of revenues from its Bristol-Myers Squibb-partnered megablockbuster blood thinner, Plavix (clopidogrel), fell 10% to EUR505 million, while global sales of its antihypertensive, Avapro (irbesartan), also partnered with BMS, plummeted 26% to EUR334 million in the third quarter. http://blog.pharmtech.com/2012/10/29/third-quarter-revenues-wounded-bypatent-expiries/ 2 EXTRACTABLES & LEACHABLES 9 ALZHEIMER’S DISEASE 5 NEWS 10 BLOGS 7 QUALITY BY DESIGN 11 TECHNOLOGY 8 BIOSIMILAR mAbS 12 STAFF http://blog.pharmtech.com/2012/10/23/roche-under-ema-investigation/ http://blog.pharmtech.com/2012/10/29/third-quarter-revenues-wounded-by-patent-expiries/

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - November 2012

Pharmaceutical Technology Europe - November 2012
Contents
Cover Story: Examining the Growing Challenge of Extractables & Leachables: An Industry Roundtable
News Bites
Applying Quality by Design for Extended-Release Hydrophilic Matrix Tablets
EU Sets Guidelines for Biosimilar Monoclonal Antibodies
Will Europe Discourage the Launch of New Alzheimer’s Drugs?
Blogs: Roche Under Investigation; Q3 Financial Reports
Top IT Technologies

Pharmaceutical Technology Europe - November 2012