Blog
RSS FeedPosted by Michael Wonder on 17 May 2019
Celgene receives European Commission approvals for Revlimid (lenalidomide) and Imnovid (pomalidomide)-based triplet combination regimens for patients with multiple myeloma
16 May 2019 - The European Commission has approved two of Celgene’s IMiD based combination regimens. ...
Posted by Michael Wonder on 16 May 2019
Will drugs companies follow EU agency from London to Amsterdam?
16 May 2019 - Amid the bustling skyscrapers of London’s Canary Wharf, one building stands silent and shuttered — a ...
Posted by Michael Wonder on 14 May 2019
EMA begins search for next Executive Director
14 May 2019 - As Guido Rasi wraps up his second five-year term as the executive director of the European ...
Posted by Michael Wonder on 09 May 2019
Nabriva Therapeutics announces submission of marketing authorisation application for lefamulin to treat community-acquired pneumonia in adults by European Medicines Agency
8 May 2019 - Nabriva Therapeutics announced that the Company’s marketing authorisation application for both the intravenous and oral ...
Posted by Michael Wonder on 08 May 2019
European Commission approves Lorviqua (lorlatinib) for certain adult patients with previously treated ALK positive advanced non-small cell lung cancer
7 May 2019 - Pfizer today announced that the European Commission granted conditional marketing authorisation for Lorviqua (lorlatinib, available in ...
Posted by Michael Wonder on 08 May 2019
Dupixent (dupilumab) approved for severe asthma by European Commission
7 May 2019 - Only biologic approved in the European Union for severe asthma with type 2 inflammation, as characterised by ...
Posted by Michael Wonder on 08 May 2019
Akcea and Ionis announce approval of Waylivra (volanesorsen) in the European Union
7 May 2019 - Akcea Therapeutics and Ionis Pharmaceuticals announced today that Waylivra has received conditional marketing authorisation from the ...
Posted by Michael Wonder on 07 May 2019
Working together for safe medicines in the EU
6 May 2019 - EMA launches a social media campaign to highlight how the European medicines regulatory network keeps medicines ...
Posted by Michael Wonder on 07 May 2019
European Commission approves Palynziq (pegvaliase injection) for treatment of phenylketonuria in patients aged 16 years or older
6 May 2019 - First enzyme substitution therapy approved in Europe to treat the underlying cause of phenylketonuria in patients aged ...
Posted by Michael Wonder on 30 Apr 2019
Two additional countries to benefit from EU-US mutual recognition agreement for inspections
30 April 2019 - In April 2019, the US FDA confirmed the capability of two additional European Union Member States ...
Posted by Michael Wonder on 30 Apr 2019
European Commission approves Skyrizi (risankizumab) for the treatment of moderate to severe plaque psoriasis
30 April 2019 - Approval based on results from clinical studies showing high rates of skin clearance at 16 weeks; this ...
Posted by Michael Wonder on 29 Apr 2019
Zynquista now approved in the European Union for treatment of adults with type 1 diabetes
27 April 2019 - The European Commission has granted marketing authorisation for Zynquista (sotagliflozin), developed by Sanofi and Lexicon. ...
Posted by Michael Wonder on 28 Apr 2019
Evolus receives positive CHMP opinion for Nuceiva in the European Union
26 April 2019 - European Commission approval anticipated within 90 days. ...
Posted by Michael Wonder on 28 Apr 2019
Pfizer receives positive CHMP opinion for Talzenna (talazoparib) for patents with inherited (germline) BRCA mutated locally advanced or metastatic breast cancer
26 April 2019 - Positive opinion based on results from largest Phase 3 trial performed to date of a PARP inhibitor ...
Posted by Michael Wonder on 28 Apr 2019
Celgene Corporation and Acceleron Pharma announce submission of luspatercept marketing authorisation application to the EMA for MDS and beta-thalassemia
26 April 2019 - Submission to EMA follows biologics licensing application submission to U.S. FDA earlier this month. ...