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RSS FeedPosted by Michael Wonder on 21 Dec 2020
EMA recommends first COVID-19 vaccine for authorisation in the EU
21 December 2020 - EMA has recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, ...
Posted by Michael Wonder on 21 Dec 2020
European Commission approves Aimmune’s Palforzia as first-ever treatment for peanut allergy in the EU
21 December 2020 - Peanut allergy is one of the most common food allergies in Europe. ...
Posted by Michael Wonder on 18 Dec 2020
Novo Nordisk files for EU regulatory approval of once weekly semaglutide 2.4 mg for weight management
18 December 2020 - Novo Nordisk today announced the submission of a marketing authorisation application to the EMA for subcutaneous semaglutide ...
Posted by Michael Wonder on 17 Dec 2020
Kite’s Tecartus (KTE-X19) granted conditional marketing authorisation for the treatment of relapsed or refractory mantle cell lymphoma in Europe
16 December 2020 - 93% of patients in ZUMA-2 pivotal trial responded to single infusion of Tecartus. ...
Posted by Michael Wonder on 17 Dec 2020
Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine
17 December 2020 - Over the last few weeks, EMA has made good progress on the assessment of the marketing authorisation ...
Posted by Michael Wonder on 16 Dec 2020
Pressure mounts on EU drug regulator to approve Pfizer COVID-19 vaccine
15 December 2020 - Europe’s drug regulator is under increasing pressure to quickly approve the COVID-19 vaccine developed by U.S. giant ...
Posted by Michael Wonder on 15 Dec 2020
Roche launches cobas PIK3CA mutation test for patients with advanced or metastatic breast cancer in countries accepting the CE mark
15 December 2020 - This genetic test identifies mutations in the PIK3CA gene that can cause cells to grow uncontrollably, which ...
Posted by Michael Wonder on 15 Dec 2020
Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
15 December 2020 - EMA’s CHMP and its experts have been working intensively over the past weeks to evaluate data ...
Posted by Michael Wonder on 15 Dec 2020
Imfinzi recommended for approval in the EU by CHMP for less-frequent, fixed-dose use in unresectable non-small cell lung cancer
15 December 2020 - Option would extend dosing from two to four weeks, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 15 Dec 2020
European CHMP adopts positive opinion for Heplisav-B, Dynavax's two dose adult hepatitis B adjuvanted vaccine
10 December 2020 - If approved, Heplisav-B will be the only two dose adult hepatitis B vaccine offering protection in just ...
Posted by Michael Wonder on 14 Dec 2020
Novartis receives EU approval for Leqvio (inclisiran), a first-in-class siRNA to lower cholesterol with two doses a year
11 December 2020 - Leqvio (inclisiran) is the first and only approved small-interfering RNA (siRNA) low-density lipoprotein cholesterol lowering treatment in ...
Posted by Michael Wonder on 14 Dec 2020
ExCellThera receives Priority Medicines (PRIME) designation from European Medicines Agency for ECT-001 cell therapy
11 December 2020 - ExCellThera announced today that ECT-001 cell therapy has been granted PRIority MEdicines (PRIME) designation by the EMA ...
Posted by Michael Wonder on 14 Dec 2020
Trixeo Aerosphere approved in the EU for maintenance treatment of COPD
14 December 2020 - Fourth major approval for AstraZeneca’s triple-combination therapy which is marketed as Breztri Aerosphere in the US, ...
Posted by Michael Wonder on 14 Dec 2020
Janssen receives positive CHMP opinion for Spravato (esketamine nasal spray) for the rapid reduction of depressive symptoms in a psychiatric emergency for patients with major depressive disorder
11 December 2020 - Positive opinion is based on results from two Phase 3 ASPIRE studies in adult patients with moderate ...
Posted by Michael Wonder on 14 Dec 2020
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) as first-line treatment in adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
11 December 2020 - Opinion granted based on significant progression-free survival benefit demonstrated with Keytruda monotherapy compared to standard of ...