Blog
RSS FeedPosted by Michael Wonder on 03 Aug 2021
Amicus Therapeutics announces European Commission approval of Galafold (migalastat) for adolescents with Fabry disease
2 August 2021 - Galafold is the first and only oral therapy approved in the EU for the long-term treatment of ...
Posted by Michael Wonder on 02 Aug 2021
Pfizer, Moderna raise prices of COVID-19 coronavirus vaccines for European Union
1 August 2021 - What’s the best way to get more people vaccinated against COVID-19 to try to end the ...
Posted by Michael Wonder on 02 Aug 2021
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as adjuvant treatment for oesophageal or gastro-oesophageal junction cancer patients with residual pathologic disease following chemoradiotherapy
30 July 2021 - Approval is based on Phase 3 results from the CheckMate-577 trial. ...
Posted by Michael Wonder on 02 Aug 2021
Working towards harmonised access to clinical trial data across European drug regulatory agencies
31 July 2021 - On 31 May 2021, a group of researchers and NGOs submitted an open letter to the ...
Posted by Michael Wonder on 02 Aug 2021
Six month countdown to go live for the Clinical Trials Information System
2 August 2021 - The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and ...
Posted by Michael Wonder on 31 Jul 2021
Increased manufacturing capacity and supply for Spikevax
30 July 2021 - EMA's CHMP has approved a scale-up of the active substance production process at Moderna's COVID-19 vaccine ...
Posted by Michael Wonder on 29 Jul 2021
GSK and Vir Biotechnology announce Joint Procurement Agreement with European Commission for COVID-19 treatment sotrovimab
28 July 2021 - GSK and Vir Biotechnology today announced they have signed a Joint Procurement Agreement with the European ...
Posted by Michael Wonder on 26 Jul 2021
Rhythm Pharmaceuticals announces European Commission authorisation of Imcivree (setmelanotide) for the treatment of obesity and control of hunger associated with POMC, PCSK1 and LEPR deficiency
23 July 2021 - First ever authorised treatment option in the European Union for these rare genetic diseases of obesity. ...
Posted by Michael Wonder on 26 Jul 2021
Ultomiris recommended for approval in the EU by CHMP for children and adolescents with paroxysmal nocturnal haemoglobinuria
26 July 2021 - Opinion based on results from Ultomiris Phase 3 trial that showed an established efficacy and safety ...
Posted by Michael Wonder on 25 Jul 2021
EMA CHMP adopts positive opinion recommending authorisation for the use of the Moderna COVID-19 Vaccine in adolescents (12-17 years of age) in the European Union
23 July 2021 - . 23, 2021-- Moderna today announced that the EMA's CHMP adopted a positive opinion recommending marketing authorisation ...
Posted by Michael Wonder on 25 Jul 2021
Highlights from the 19-22 July CHMP meeting
23 July 2021 - Two new medicines recommended for approval. ...
Posted by Michael Wonder on 24 Jul 2021
Kyowa Kirin provides update on application for marketing authorisation of istradefylline in Europe for the treatment of ‘OFF’ episodes in people living with Parkinson’s
23 July 2021 - Kyowa Kirin today announced that the EMA's CHMP issued a negative opinion for istradefylline as an add-on ...
Posted by Michael Wonder on 24 Jul 2021
COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU
23 July 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax (previously COVID-19 Vaccine ...
Posted by Michael Wonder on 22 Jul 2021
Bayer’s new symptomatic chronic heart failure treatment Verquvo (vericiguat) approved in EU
21 July 2021 - Approved for adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring ...
Posted by Michael Wonder on 22 Jul 2021
bluebird bio receives EC approval for Skysona (elivaldogene autotemcel, Lenti-D) gene therapy for patients less than 18 years of age with early cerebral adrenoleukodystrophy without matched sibling donor
21 July 2021 - Skysona is the first and only gene therapy approved in the European Union to treat early CALD. ...