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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Xydalba (dalbavancin) receives CHMP positive opinion for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults
Actavis plc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted Actavis' subsidiary Durata Therapeutics International, ...
Posted by Michael Wonder on 05 Aug 2015
GSK receives EU marketing authorisation for Mekinist (trametinib) for patients with unresectable or metastatic melanoma with a BRAF V600 mutation
GlaxoSmithKline plc today announced that the European Commission (EC) has granted marketing authorisation for Mekinist (trametinib) as a single agent in the ...
Posted by Michael Wonder on 05 Aug 2015
Boehringer Ingelheim statement on hepatitis C drug development
20 June 2014 - Boehringer Ingelheim has re-evaluated its strategy in hepatitis C (HCV), and as a result the company has decided ...
Posted by Michael Wonder on 05 Aug 2015
The EU Commission approves Helsinn’s Akynzeo (netupitant/palonosetron) for prevention of chemotherapy-induced nausea and vomiting in European Union
Helsinn, the Swiss Group focused on building quality cancer care, announced today that on May 27, 2015, the European Commission (EC) approved Akynzeo ...
Posted by Michael Wonder on 05 Aug 2015
EMA recommends approval of treatment for attention deficit hyperactivity disorder
The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Intuniv (guanfacine) to treat attention deficit hyperactivity disorder (ADHD) in ...
Posted by Michael Wonder on 05 Aug 2015
Newron Parkinson's drug Xadago gets Europe okay
The European Commission has given the green light to Newron Pharmaceuticals of Italy’s Parkinson’s disease drug Xadago. ...
Posted by Michael Wonder on 05 Aug 2015
Professor Sir Michael Rawlins appointed Chair of Medicines and Healthcare Products Regulatory Agency
The Medicines and Healthcare Products Regulatory Agency today announced the appointment of Professor Sir Michael Rawlins as its new Chair. ...
Posted by Michael Wonder on 05 Aug 2015
Cerdelga recommended for approval in type 1 Gaucher disease
The EMA has recommended granting a marketing authorisation in the European Union (EU) for Cerdelga (eliglustat), for the treatment of type 1 Gaucher ...
Posted by Michael Wonder on 05 Aug 2015
Facilitating the development of advanced therapies
The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) and the International Society for Cellular Therapy (ISCT) are organising a workshop ...
Posted by Michael Wonder on 05 Aug 2015
Keryx receives CHMP positive opinion for Fexeric (ferric citrate coordination complex) for the treatment of hyperphosphatemia in adults with kidney disease
Keryx Biopharmaceuticals, Inc. today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion ...
Posted by Michael Wonder on 05 Aug 2015
New treatment option recommended for patients with advanced melanoma
The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Keytruda (pembrolizumab). It is recommended as monotherapy for the treatment ...
Posted by Michael Wonder on 05 Aug 2015
EMA explains its redaction rules
The European Medicines Agency (EMA) has published a detailed response to the European Ombudsman’s questions related to the redaction of certain elements ...
Posted by Michael Wonder on 05 Aug 2015
Adjusted fees for applications to European Medicines Agency from 1 April 2015
Fees payable to the European Medicines Agency by applicants and marketing-authorisation holders are decreasing by 0.1% on 1 April 2015. ...
Posted by Michael Wonder on 05 Aug 2015
European Medicines Agency grants accelerated assessment of ixazomib for patients with relapsed/refractory multiple myeloma
Takeda Pharmaceutical Company Limited today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...
Posted by Michael Wonder on 05 Aug 2015
Hetlioz receives European Commission approval for the treatment of non-24-hour sleep-wake disorder in the totally blind
Vanda Pharmaceuticals Inc. today announced that the European Commission (EC) approved Hetlioz (tasimelteon) for the treatment of non-24-hour sleep-wake disorder (Non-24) in totally ...