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RSS FeedPosted by Michael Wonder on 27 Jun 2021
Samsung Bioepis and Biogen receive positive CHMP opinion for ranibizumab biosimilar, Byooviz
25 June 2021 - Samsung Bioepis and Biogen today announced that the EMA's CHMP has adopted a positive opinion for Byooviz, ...
Posted by Michael Wonder on 27 Jun 2021
Highlights from 21-24 June CHMP meeting
25 June 2021 - EMA’s CHMP recommended eight medicines for approval at its June 2021 meeting. ...
Posted by Michael Wonder on 26 Jun 2021
CHMP recommends approval of Rinvoq (upadacitinib) for the treatment of atopic dermatitis
25 June 2021 - Positive opinion based on three global Phase 3 pivotal clinical trials evaluating the safety and efficacy of ...
Posted by Michael Wonder on 23 Jun 2021
Genmab announces that Janssen has received European marketing authorisations for Darzalex (daratumumab) subcutaneous formulation, including for the treatment of patients with newly diagnosed light-chain amyloidosis
22 June 2021 - Janssen received European approval for Darzalex SC (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone ...
Posted by Michael Wonder on 23 Jun 2021
LEO Pharma announces European Commission approval of Adtralza (tralokinumab) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis
22 June 2021 - The European Commission regulatory approval is primarily supported by data from the ECZTRA 1, 2 and ECZTRA ...
Posted by Michael Wonder on 22 Jun 2021
Two additional manufacturing sites for BioNTech/Pfizer’s COVID-19 vaccine
22 June 2021 - EMA’s CHMP has approved additional manufacturing sites for the production of Comirnaty, the COVID-19 vaccine developed ...
Posted by Michael Wonder on 22 Jun 2021
Koselugo approved in the EU for children with neurofibromatosis type 1 and plexiform neurofibromas
22 June 2021 - First medicine approved in the EU to treat this rare and debilitating genetic condition. ...
Posted by Michael Wonder on 22 Jun 2021
Jardiance (empagliflozin) approved in Europe for the treatment of heart failure with reduced ejection fraction
21 June 2021 - This new indication is based on the EMPEROR Reduced trial, which showed a significant 25% reduction in ...
Posted by Michael Wonder on 22 Jun 2021
Bristol Myers Squibb receives European Commission approval for Onureg (azacitidine tablets) as frontline oral maintenance therapy for adults with acute myeloid leukaemia
18 June 2021 - Onureg is the first and only once daily, frontline oral maintenance therapy in the European Union for ...
Posted by Michael Wonder on 21 Jun 2021
Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a ...
Posted by Michael Wonder on 21 Jun 2021
EMA publishes agenda for 21-24 June CHMP meeting
21 June 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 20 Jun 2021
AstraZeneca welcomes court ruling on supply of its COVID-19 vaccine to Europe
18 June 2021 - AstraZeneca today welcomed the ruling by the Court of First Instance in Brussels. The European Commission had ...
Posted by Michael Wonder on 19 Jun 2021
European regulator EMA says it won't set 50% efficacy threshold for COVID shots
18 June 2021 - The EMA said on Thursday it would not impose a 50% efficacy threshold for COVID-19 vaccines, ...
Posted by Michael Wonder on 18 Jun 2021
European Commission approves Aubagio (teriflunomide) as the first oral MS therapy for first-line treatment of children and adolescents living with relapsing-remitting multiple sclerosis
18 June 2021 - The European Commission has approved Aubagio (teriflunomide) for the treatment of paediatric patients 10 to 17 years ...
Posted by Michael Wonder on 14 Jun 2021
Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
11 June 2021 - EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not ...