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RSS FeedPosted by Michael Wonder on 14 Sep 2021
Alnylam submits marketing authorisation application to the European Medicines Agency for investigational vutrisiran for the treatment of hereditary ATTR amyloidosis with polyneuropathy
13 September 2021 - If approved, vutrisiran will provide a new, subcutaneously administered, once quarterly treatment option for patients with hATTR ...
Posted by Michael Wonder on 14 Sep 2021
Mirum Pharmaceuticals submits European marketing authorisation application for maralixibat in Alagille syndrome supported by new positive results from natural history study comparison
13 September 2021 - Natural history analysis shows significant improvement in event-free survival and transplant-free survival. ...
Posted by Michael Wonder on 13 Sep 2021
EMA publishes agenda for 13-16 September CHMP meeting
13 September 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 06 Sep 2021
EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty
6 September 2021 - EMA has started evaluating an application for the use of a booster dose of Comirnaty to be ...
Posted by Michael Wonder on 05 Sep 2021
Moderna announces submission of data to European Medicines Agency for its COVID-19 vaccine booster
3 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against ...
Posted by Michael Wonder on 04 Sep 2021
GSK’s shingles vaccine Shingrix gains UK license
2 September 2021 - GlaxoSmithKline's Shingrix has been licensed in the UK for the prevention of shingles in adults aged ...
Posted by Michael Wonder on 03 Sep 2021
Ultomiris approved in the EU for children and adolescents with paroxysmal nocturnal haemoglobinuria
3 September 2021 - Approval based on interim results from Phase 3 trial demonstrating complete terminal complement inhibition with reduced ...
Posted by Michael Wonder on 02 Sep 2021
ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines
2 September 2021 - Based on current evidence, there is no urgent need for the administration of booster doses of vaccines ...
Posted by Michael Wonder on 28 Aug 2021
European Medicines Agency grants Marinus Pharmaceuticals accelerated assessment of ganaxolone for treatment of CDKL5 deficiency disorder
26 August 2021 - Marinus Pharmaceuticals today announced that the CHMP of the EMA has granted its request for accelerated ...
Posted by Michael Wonder on 28 Aug 2021
Incyte and MorphoSys announce the European Commission approval of Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma
26 August 2021 - In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL. ...
Posted by Michael Wonder on 28 Aug 2021
European Commission approves BioMarin's Voxzogo (vosoritide) for the treatment of children with achondroplasia from age 2 until growth plates close
27 August 2021 - First medicine approved to treat children with achondroplasia in Europe ...
Posted by Michael Wonder on 27 Aug 2021
Argenx announces validation of European marketing authorisation application for efgartigimod in generalised myasthenia gravis
25 August 2021 - Validation initiates formal evaluation of application which started on 19 August 2021; decision expected mid-2022. ...
Posted by Michael Wonder on 26 Aug 2021
Sesen Bio pulls E.U. application for FDA rejected cancer drug
26 August 2021 - Sesen Bio, a small biotech firm whose investigational cancer treatment once seemed poised for approval, said ...
Posted by Michael Wonder on 24 Aug 2021
Immunocore announces that U.S. Food and Drug Administration and European Medicines Agency accept biologics license application and marketing authorisation application for tebentafusp in metastatic uveal melanoma
24 August 2021 - FDA grants priority review to tebentafusp for the treatment of HLA-A*02:01 positive patients with metastatic uveal melanoma; ...
Posted by Michael Wonder on 24 Aug 2021
Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech/Pfizer and Moderna
24 August 2021 - EMA’s CHMP has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the ...