Collaboration - June 5, 2015
Biogen Files MAA for Hemophilia Drug
Swedish Orphan Biovitrum AB (Sobi’s) partner Biogen has submitted a Marketing Authorisation Application (MAA) for Alprolix (rFIXFc) to the European Medicines Agency (EMA). Sobi has an opt-in right to assume final development and commercialization of Alprolix in Europe, Russia, certain countries in the Middle East, and North Africa, according to Sobi. The MAA filing with […]
Drug Development Pharma - January 26, 2015
EMA Accepts AZ Gout Drug
AstraZeneca’s application for lesinurad, an unevenly successful gout treatment, has been accepted by the European Medicines Agency (EMA). AstraZeneca acquired lesinurad as part of the $1.3 billion purchase of Ardea Biosciences in 2013. The EMA’s Committee for Medicinal Products for Human Use now will decide whether to grant approval to lesinurad to supplement the usual […]
Drug Development Pharma - January 12, 2015
2014 Year of Orphan Drugs
The European Medicines Agency (EMA) recommended the highest number of orphan designated medicines for marketing authorization in a single year in 2014. Out of the 82 medicines for human use recommended last year, 17 are meant for the treatment of a rare disease, serving patients who frequently have a few or no treatment options. Among […]
Pharma article - August 8, 2014
Europe boosts cooperation with international partners on generics
The European Union’s decentralised procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International Generic Drug Regulators Pilot. The EU is currently leading an international pilot project through which it will share the assessment reports generated as part of the decentralised procedure in real […]
Drug Development Pharma - August 5, 2014
EMA looks to stimulate better use of genomic data in medicines development
The agency is taking a look at better use of genomic data and biomarkers in medicines development and safety monitoring. The European Medicines Agency has released a draft concept paper for public consultation outlining the key elements that will be developed in a guideline on good genomics biomarker practices. The concept paper proposes a framework for the generation […]
Drug Development Pharma - June 25, 2014
Sobi files for EU approval of Xiapex for Peyronies disease
Sobi has filed for an extension of the label for Xiapex with the European Medicines Agency (EMA) to include the indication of Peyronie’s disease. The filing is based on positive safety and efficacy outcome data from two double-blind placebo-controlled studies, IMPRESS I and II (The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies) which […]
