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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Novartis Cosentyx receives positive CHMP opinion for first-line treatment of moderate-to-severe psoriasis patients
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval ...
Posted by Michael Wonder on 05 Aug 2015
Europe to boost international co-operation on generics
The European Medicines Agency (EMA) is ready to share its assessments of applications for generic medicines in real time with ...
Posted by Michael Wonder on 05 Aug 2015
Vertex submits applications in the U.S. and Europe for approval of lumacaftor in combination with ivacaftor for people with cystic fibrosis who have two copies of the F508del mutation
Vertex Pharmaceuticals Incorporated today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a ...
Posted by Michael Wonder on 05 Aug 2015
EMA getting ready for the publication of clinical data
The European Medicines Agency (EMA) will hold a webinar on Wednesday 24 June to update stakeholders on the implementation of its policy ...
Posted by Michael Wonder on 05 Aug 2015
Eli Lilly gets European approval to sell Trulicity, a type 2 diabetes drug
Eli Lilly, the American pharmaceutical giant, said on Tuesday that it had received European approval to sell its new drug ...
Posted by Michael Wonder on 05 Aug 2015
EMA publishes CHMP assessment report for Accofil (filgrastim)
The EMA has published a summary of the European public assessment report (EPAR) for Accofil. It explains how the Agency assessed the medicine ...
Posted by Michael Wonder on 05 Aug 2015
Gardasil 9 offers wider protection against cancers caused by human papillomavirus
The European Medicines Agency (EMA) has recommended Gardasil 9 (human papillomavirus vaccine) for the prevention of diseases caused by nine ...
Posted by Michael Wonder on 05 Aug 2015
Amgen submits applications in the US and Europe for Kyprolis (carfilzomib) for the treatment of relapsed multiple myeloma
Amgen and its subsidiary Onyx Pharmaceuticals, Inc., today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and ...
Posted by Michael Wonder on 05 Aug 2015
Xiapex approved by the EU Commission for the treatment of Peyronie's disease
Swedish Orphan Biovitrum AB (Sobi) today announced that the EU Commission has approved Xiapex (collagenase clostridium histolyticum) for the treatment of adult ...
Posted by Michael Wonder on 05 Aug 2015
European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments
The European Medicines Agency Management Board on 12 June 2014 agreed the policy on publication of clinical trial data, together with more ...
Posted by Michael Wonder on 05 Aug 2015
EMA tightens rules on 'revolving door' for committee members and experts
The European Medicines Agency (EMA) has updated its rules on declarations of interests for scientific committee members and experts. The ...
Posted by Michael Wonder on 05 Aug 2015
GSK announces regulatory submissions for mepolizumab in severe eosinophilic asthma
GlaxoSmithKline plc today announced that it has filed regulatory submissions in the USA and Europe for mepolizumab for approval as a ...
Posted by Michael Wonder on 05 Aug 2015
Opdivo approved via UK’s early drug access scheme
The UK's drug regulator has approved Bristol-Myers Squibb's new lung cancer drug Opdivo for use in the country under a ...
Posted by Michael Wonder on 05 Aug 2015
Envarsus receives European marketing authorization for treatment of both kidney and liver transplant patients
Veloxis Pharmaceuticals A/S and Chiesi Farmaceutici S.p.A. today announced that the European Commission (EC) has granted marketing authorization for Envarsus for the ...
Posted by Michael Wonder on 05 Aug 2015
Sobi's partner Biogen submits marketing authorisation application for Alprolix (rFIXFc) in Europe
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that partner Biogen has submitted a Marketing Authorisation Application (MAA) for Alprolix (rFIXFc) to ...