Teva announces full FDA approval of SYNRIBO® (Omacetaxine Mepesuccinate) for injection
13 February 2014 | By Teva
24-month FDA post marketing commitment completed...
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IMBRUVICA™ (ibrutinib) now approved in the U.S. for patients with chronic lymphocytic leukemia who have received at least one prior therapy
13 February 2014 | By Johnson & Johnson
Janssen Biotech, Inc. announced the U.S. Food and Drug Administration has approved IMBRUVICA™ (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy...
EMA introduces product numbers to track medicines through pre-authorisation procedures
12 February 2014 | By The European Medicines Agency
The European Medicines Agency has introduced unique product identifiers (UPIs) to track medicines through pre-authorisation procedures...
Pfizer statement on joint meeting of FDA Advisory Committees
12 February 2014 | By Pfizer
Pfizer agrees with the recommendation of the joint meeting of the FDA Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee...
AbbVie expands manufacturing presence with US$320 million investment in Singapore
12 February 2014 | By AbbVie
AbbVie Inc. announces a US$320 million investment to establish operations in Singapore for small molecule and biologics active drug substance manufacturing...
High throughput nanoliter pipetting with Tecan’s MCA 384
11 February 2014 | By kdm communications
Scientists working at the Leibniz-Institute for Molecular Pharmacology (FMP) in Berlin, Germany, are benefitting from the low volume pipetting capability of a MultiChannel Arm™ (MCA) 384 for siRNA and small molecule screening...
Emperra appoints Christian Krey as new CEO to market ESYSTA® telediabetology system
11 February 2014 | By EMPERRA® GmbH
EMPERRA® GmbH E-Health Technologies announced the appointment of Dr. Christian Krey as Managing Director and CEO. Dr. Krey has many years of experience in the field of diabetes mellitus...
EMA clarifies interpretation of new variation classification categories
11 February 2014 | By The European Medicines Agency
The European Medicines Agency has clarified a number of points related to the new categories of variations to the terms of marketing authorisations that were introduced in August 2013. The related question and answer document has been updated to reflect these adjustments...
European Medicines Agency updates guidance for annual strain change of seasonal influenza vaccines
10 February 2014 | By The European Medicines Agency
The European Medicines Agency has published an update to its guidance for the annual strain change of influenza vaccines...
Trinity Biotech gains European approval for the Meritas® Troponin I (TnI) point-of-care test
10 February 2014 | By kdm communications
Trinity Biotech is pleased to announce that its landmark, high sensitivity Meritas® Troponin I (TnI) point-of-care (POC) test has obtained CE marking...
Merck and Samsung Bioepis enter collaboration agreement to develop and commercialize insulin glargine candidate for diabetes
10 February 2014 | By Merck
Merck and Samsung Bioepis Co., Ltd., announced that they have expanded their collaboration with an agreement to develop, manufacture and commercialize MK-1293...
eSubmission Gateway or web client mandatory for all eCTD submissions through the centralised procedure
7 February 2014 | By The European Medicines Agency
The European Medicines Agency reminds marketing authorisation holders that from 1 March 2014 the use of the eSubmission Gateway or web clientExternal link icon will become mandatory for all electronic Common Technical Document submissions...
International Symposium on Compound Design Technologies
7 February 2014 | By kdm communications
Cresset, Optibrium, Lhasa Limited and Chemogenomix, innovative providers of computational chemistry software and services, announce the ‘International Symposium on Compound Design Technologies: Guiding Better Decisions in Compound Design Technologies’...
Quotient Clinical celebrates its 50th RapidFACT™ program
7 February 2014 | By kdm communications
Quotient Clinical has commenced its 50th RapidFACT (Rapid Formulation development And Clinical Testing) program – a significant milestone in the development of this service...
AstraZeneca PLC fourth quarter and full year results 2013
6 February 2014 | By AstraZeneca
"As expected, our financial performance for 2013 reflects the ongoing impact from the loss of exclusivity for several key brands..."
