Four orphan drugs, three biosimilars, and one monoclonal antibody therapy have been recommended for EU market approval by the European Medicines Agency’s CHMP this month.
With treatment cost of €1m+ per patient, Glybera was the most expensive therapy ever approved in Europe. Now, Uniqure has decided to terminate post-marketing studies required for prolongation of its existing EU conditional market approval.
Following the resignation of erstwhile CEO Jim Van heusden, Karolinska Development has promoted Viktor Drvota to the position of head of the company. Drvota held the position of Chief Investment Officer before.
https://european-biotechnology.com/wp-content/uploads/2024/04/viktor-drvota.jpg472420Michael Kuhrt/wp-content/uploads/2024/07/EBM_quer_Logo_2022_400px_wihte.pngMichael Kuhrt2017-04-20 13:38:192017-04-20 13:38:19Karolinska Development: Changes at the top
Autoimmune specialist Galapagos NV (Mechelen, Belgium) has priced its 3,750,000 American Depository Shares (ADSs) in an follow-on offering led by Morgan Stanley at $90 per ADS.
In December 2016, US biotech company Ionis Pharmaceuticals’ drug Spinraza received regulatory approval in the US. No doubt: the antisense technology behind Spinraza could be the next big thing
Irish Allergan and Swiss Novartis have agreed to start a proof-of-concept study of a combination of their NASH candidates cenicriviroc (Allergan) and FXR agonist LJN452 (Novartis).
sphingotec GmbH and bestbion dx GmbH have signed an agreement to market sphingotec’s innovative sepsis and congestive heart failure test (sphingotest bio-ADM) and acute kidney function monitoring assay (sphingotest penKid) in Germany and Austria.
EMA backs authorisation of biologics
Latest NewsFour orphan drugs, three biosimilars, and one monoclonal antibody therapy have been recommended for EU market approval by the European Medicines Agency’s CHMP this month.
Uniqure withdraws €1m drug Glybera from market
Latest NewsWith treatment cost of €1m+ per patient, Glybera was the most expensive therapy ever approved in Europe. Now, Uniqure has decided to terminate post-marketing studies required for prolongation of its existing EU conditional market approval.
Karolinska Development: Changes at the top
AppointmentsGE partner Synpromics completes financing round
Latest NewsSynthetic promoter and gene expression specialist Synpromics has completed a £5.2m (€6.2m) financing round with existing investors.
e-Therapeutics: Newly in charge
AppointmentsGalapagos raises US$338m
Latest NewsAutoimmune specialist Galapagos NV (Mechelen, Belgium) has priced its 3,750,000 American Depository Shares (ADSs) in an follow-on offering led by Morgan Stanley at $90 per ADS.
A potentially game-changing technology
OpinionAllergan and Novartis combine NASH candidates
Latest NewsIrish Allergan and Swiss Novartis have agreed to start a proof-of-concept study of a combination of their NASH candidates cenicriviroc (Allergan) and FXR agonist LJN452 (Novartis).
Domainex: Navigating the growth
Appointmentsbestbion dx to market sphingotec’s predictive biomarkers
Latest Newssphingotec GmbH and bestbion dx GmbH have signed an agreement to market sphingotec’s innovative sepsis and congestive heart failure test (sphingotest bio-ADM) and acute kidney function monitoring assay (sphingotest penKid) in Germany and Austria.