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RSS FeedPosted by Michael Wonder on 05 Aug 2015
GSK files ultra-rare disease application with EMA
GlaxoSmithKline has become the first big pharma firm to file for a European marketing authorisation for a gene therapy to ...
Posted by Michael Wonder on 05 Aug 2015
Otsuka’s Jinarc the first-ever treatment approved in Europe for adults living with ADPKD, a chronic genetic kidney disease
Otsuka Pharmaceutical Co., Ltd. announced today that the European Commission has granted marketing authorisation for JINARC® (tolvaptan) for the treatment ...
Posted by Michael Wonder on 05 Aug 2015
Europe clears Simponi for non-radiographic axial spondyloarthritis
The European Commission has approved MSD’s biologic Simponi for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis. ...
Posted by Michael Wonder on 05 Aug 2015
GSK announces EU regulatory submission seeking additional indication for eltrombopag (Revolade)
GSK today announced the submission to the European Medicines Agency (EMA) of a variation to the Marketing Authorisation for eltrombopag ...
Posted by Michael Wonder on 05 Aug 2015
Staying safe when buying medicines online
Patients in the European Union (EU) will now be able to easily identify legally operating online medicine retailers. To help ...
Posted by Michael Wonder on 05 Aug 2015
Agenda for CHMP meeting - June 2014
The agenda for the June 23-26 CHMP meeting has been posted in the EMA website. A summary of the meeting will ...
Posted by Michael Wonder on 05 Aug 2015
Type 2 diabetes: Synjardy (empagliflozin/metformin hydrochloride) approved in the European Union
Synjardy has been granted marketing authorisation by the European Commission for the treatment of adults with type 2 diabetes (T2D) in ...
Posted by Michael Wonder on 05 Aug 2015
European Medicines Agency validates marketing authorisation application for Zinbryta (daclizumab high-yield process) for treatment of MS
Today Biogen and AbbVie announced that the European Medicines Agency (EMA) has validated the companies’ Marketing Authorisation Application (MAA) for Zinbryta (daclizumab high-yield process) for ...
Posted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb receives positive CHMP opinion in the European Union for Opdivo (nivolumab) for the treatment of advanced melanoma in both first-line and previously treated patients
Bristol-Myers Squibb Company today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) ...
Posted by Michael Wonder on 05 Aug 2015
AbbVie's Humira (adalimumab) approved by European Commission to treat children and adolescents with severe chronic plaque psoriasis
AbbVie announced today that the European Commission (EC) has granted marketing authorization for Humira (adalimumab) for the treatment of severe chronic plaque ...
Posted by Michael Wonder on 05 Aug 2015
Europe approves J&J's Imbruvica for blood cancers
Regulators in Europe have given the green light to Johnson & Johnson/Pharmacyclics’ closely-watched Imbruvica for two forms of blood cancer. ...
Posted by Michael Wonder on 05 Aug 2015
The Medicines Company receives European Commission approval for three hospital acute care products: Kengrexal (cangrelor), Orbactiv (oritavancin) and Raplixa (sealant powder)
30 March 2015 - The Medicines Company today announced that the European Commission has granted marketing authorization for three of its hospital acute care products ...
Posted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb receives positive CHMP opinion in the European Union for nivolumab (Opdivo) for the treatment of advanced squamous non small cell lung cancer in previously treated patients
Bristol-Myers Squibb Company today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) ...
Posted by Michael Wonder on 05 Aug 2015
Record number of medicines for rare diseases recommended for approval in 2014
In 2014, the European Medicines Agency (EMA) recommended the highest number of orphan designated medicines for marketing authorisation in a year. Out ...
Posted by Michael Wonder on 05 Aug 2015
European Medicines Agency validates and grants accelerated assessment of marketing authorization application for Empliciti (elotuzumab) for the treatment of multiple myeloma in patients who have received one or more prior therapies
Bristol-Myers Squibb Company and AbbVie today announced the European Medicines Agency (EMA) validated for review the Marketing Authorization Application (MAA) for Empliciti, an ...