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RSS FeedPosted by Michael Wonder on 26 May 2016
EMA publishes EPAR for selexipag (Uptravi)
26 May 2016 - The EMA has published an EPAR for selexipag (Uptravi). ...
Posted by Michael Wonder on 25 May 2016
EMA publishes EPAR for eftrenonacog alfa (Alprolix)
25 May 2016 - The EMA has published an EPAR for eftrenonacog alfa (Alprolix). ...
Posted by Michael Wonder on 24 May 2016
Genmab announces European conditional marketing authorization for Darzalex (daratumumab) for multiple myeloma
24 May 2016 - Genmab announced today that the European Commission has granted a conditional marketing authorization for first-in-class CD38 antibody ...
Posted by Michael Wonder on 24 May 2016
Sandoz' biosimilar rituximab regulatory submission accepted by European Medicines Agency
24 May 2016 - Sandoz is seeking approval for all indications included in the reference product's label. ...
Posted by Michael Wonder on 19 May 2016
EMA publishes EPAR for Empliciti (Elotuzumab)
19 May 2016 - Empliciti was approved by the European Commission with additional monitoring on 11 May 2016. ...
Posted by Michael Wonder on 17 May 2016
Actelion is granted market authorisation for Uptravi (selexipag) in pulmonary arterial hypertension by the European Commission
17 May 2016 - Actelion announced today that the European Commission has granted marketing authorization in the EU for the orally ...
Posted by Michael Wonder on 13 May 2016
Alprolix approved in the EU for the treatment of haemophilia B
13 May 2016 - Alprolix is the first Fc fusion therapy approved for haemophilia B in the EU to provide ...
Posted by Michael Wonder on 12 May 2016
European Commission approval of CSL's Idelvion
12 May 2016 - The European Commission has approved Idelvion for the treatment and prophylaxis of bleeding in patients with ...
Posted by Michael Wonder on 11 May 2016
Bristol-Myers Squibb and AbbVie announce European Commission approval of Empliciti (elotuzumab) for the treatment of multiple myeloma in adult patients who have received at least one prior therapy
11 May 2016 - Bristol-Myers Squibb and AbbVie announced today that the European Commission has approved Empliciti (elotuzumab) for the treatment ...
Posted by Michael Wonder on 11 May 2016
Drug regulation and pricing — can regulators influence affordability?
12 May 2016 - Although drug regulators aren’t supposed to be concerned with pricing, they’ve been drawn into an acrimonious debate ...
Posted by Michael Wonder on 11 May 2016
Supporting innovative SMEs as major drivers of new pharmaceutical developments
12 May 2016 - EMA publishes report on the first ten years of its SME initiative. ...
Posted by Michael Wonder on 11 May 2016
The European Medicines Agency is still too close to industry
6 May 2016 - Two decades after its inception, the agency still fails to put patients’ interests first. ...
Posted by Michael Wonder on 05 May 2016
European Commission approves Halaven (eribulin mesylate) for treatment of advanced liposarcoma in Europe
5 May 2016 - People with advanced liposarcomas in Europe may now be able to receive Halaven (eribulin mesylate), the first ...
Posted by Michael Wonder on 05 May 2016
Ferring Pharmaceuticals announces approval for Nocdurna, a new therapeutic option for the treatment of adults waking multiple times to urinate at night
3 May 2016 - Ferring Pharmaceuticals today announced that Nocdurna (desmopressin) has received approval in the EU for the symptomatic treatment ...
Posted by Michael Wonder on 04 May 2016
BioMarin announces EMA grants accelerated assessment for cerliponase alfa, experimental treatment for a form of Batten disease
3 May 2016 - BioMarin today announced that the EMA has granted BioMarin's request for accelerated assessment for the planned cerliponase ...