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EMA to review Sandoz biosimilars adalimumab and infliximab europeanpharmaceuticalreview
June 05, 2017
Sandoz, a Novartis division, announced that the European Medicines Agency (EMA) has accepted for regulatory review their marketing authorisation applications for biosimilars to AbbVie‘s Humira (adalimumab) and Janssen‘s Remicade (infliximab)...
Green light given for new EudraVigilance system for collection and monitoring of suspected adverse r worldpharmanews
June 01, 2017
The European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area
Relocating the EMA: An open letter from EFPIA and Pharma Heads of Research europeanpharmaceuticalreview
May 17, 2017
Our current system of medicines regulation offers an outstanding example of European cooperation at its finest.
Aptar Pharma’s Electronic Lockout Device Approved by EMA contractpharma
May 16, 2017
Reinforces a long-standing partnership between Aptar Pharma and Takeda
Sanofi and Regeneron’s Kevzara receives CHMP opinion to treat Rheumatoid Arthritis pharmaceutical-technology.
April 26, 2017
Regeneron Pharmaceuticals and Sanofi’s Kevzara (sarilumab) has received a positive opinion from the European ...
EMA gives positive opinion on Biogen’s spinal muscular atrophy drug Spinraza pharmafile
April 26, 2017
Biogen has revealed that Spinraza (nusinersen), its treatment for spinal muscular atrophy (SMA) , has received a ...
Pharma industry calls for EMA relocation by June in open EFPIA letter pharmafile
April 26, 2017
Heads of research from 19 of the biggest players in the industry have called for a decision to be made on ...
Pharma heads call for decision on EMA relocation pharmatimes
April 25, 2017
Pharma chiefs in Europe are calling on heads of state to reach a prompt decision on the new location for the European ...
EMA green lights Actelion’s drug after patient deaths scare pharmafile
April 11, 2017
The EMA has ruled that the five patient deaths that occurred in February of this year were not directly related to ...
EMA issues positive opinion for EUSA Pharma's Dinutuximab beta to treat neuroblastoma pharmaceutical-technology
March 30, 2017
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion in favour of marketing authorisation for EUSA Pharma’s ...

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