Blog
RSS FeedPosted by Michael Wonder on 16 Nov 2020
Aerie Pharmaceuticals receives positive CHMP opinion for Roclanda in the European Union
13 November 2020 - European Commission Decision Anticipated in Approximately Two Months. ...
Posted by Michael Wonder on 19 Oct 2020
Trixeo Aerosphere recommended for approval in the EU by CHMP for the maintenance treatment of COPD
19 October 2020 - Recommendation of triple-combination therapy based on positive results from ETHOS and KRONOS Phase III trials ...
Posted by Michael Wonder on 29 Sep 2020
Heron Therapeutics receives European Commission authorisation for Zynrelef (HTX-011) for the treatment of post-operative pain
28 September 2020 - Heron Therapeutics today announced that the European Commission has granted a marketing authorisation for Zynrelef (formerly known ...
Posted by Michael Wonder on 15 Sep 2020
Vertex announces European Medicines Agency type II variation marketing authorisation application validation for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor in people with one copy of the F508del mutation
14 September 2020 - Vertex Pharmaceuticals today announced the EMA has validated a type II variation marketing authorisation application for ...
Posted by Michael Wonder on 24 Aug 2020
European Commission approves Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat cystic fibrosis in people ages 12 years and older
21 August 2020 - For the first time, up to 10,000 people in Europe ages 12 years and older with one ...
Posted by Michael Wonder on 17 Jul 2020
MC2 Therapeutics announces submission of marketing authorisation application in EU for Wynzora cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate))
16 July 2020 - MC2 Therapeutics today announced the submission of its marketing authorisation application in EU for Wynzora cream (50 ...
Posted by Michael Wonder on 07 Jul 2020
Novartis receives EC approval for Enerzair Breezhaler, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU
7 July 2020 - Optional digital companion with sensor and app that provide inhalation confirmation, medication reminders and access to objective ...
Posted by Michael Wonder on 29 Jun 2020
New medicine for cystic fibrosis patients
26 June 2020 - EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Kaftrio, ...
Posted by Michael Wonder on 19 Jun 2020
Cancer Prevention Pharmaceuticals submits EU marketing authorisation application for CPP-1X/sul for treatment of familial adenomatous polyposis
18 June 2020 - Cancer Prevention Pharmaceuticals announced today that it has submitted a marketing authorisation application to the European Medicines ...
Posted by Michael Wonder on 01 May 2020
Novartis receives CHMP positive opinion for Enerzair Breezhaler (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma
1 May 2020 - Digital companion with app and sensor that provide inhalation confirmation, medication reminders and access to objective data ...
Posted by Michael Wonder on 08 Apr 2020
Esperion Announces European Commission approval of the Nustendi (bempedoic acid and ezetimibe) tablet for the treatment of hypercholesterolaemia and mixed dyslipidaemia
6 April 2020 - First non-statin, LDL-C lowering combination medicine ever approved in Europe. ...
Posted by Michael Wonder on 24 Mar 2020
Helsinn announces European approval of the IV formulation of Akynzeo (fosnetupitant with palonosetron)
23 March 2020 - Helsinn today announces that the European Commission has approved the intravenous formulation of Akynzeo, (a fixed ...
Posted by Michael Wonder on 29 Feb 2020
GSK filing accepted by European Medicines Agency for Trelegy Ellipta use in adult patients with asthma
27 February 2020 - Submission supported by pivotal CAPTAIN study demonstrating statistically significant improvement in lung function compared with the ICS/LABA, ...
Posted by Michael Wonder on 03 Feb 2020
Esperion announces positive CHMP opinion for the marketing authorisation application for bempedoic acid for the treatment of hypercholesterolaemia and mixed dyslipidaemia
31 January 2020 - Positive CHMP opinion is based on the completed pivotal Phase 3 LDL-cholesterol lowering program. ...
Posted by Michael Wonder on 03 Jan 2020
Aerie Pharmaceuticals announces acceptance for review of the Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% marketing authorisation application in Europe
2 January 2020 - Aerie Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for Roclanda ...