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RSS FeedPosted by Michael Wonder on 30 Sep 2021
Acacia Pharma announces submission and validation of marketing authorisation application for Barhemsys (amisulpride injection) in major European markets
29 September 2021 - Acacia Pharma announces that its marketing authorisation application for Barhemsys (amisulpride injection) has been submitted, validated and ...
Posted by Michael Wonder on 29 Sep 2021
EMA implements new measures to minimise animal testing during medicines development
29 September 2021 - EMA is putting in place special support to developers to replace, reduce and refine animal use for ...
Posted by Michael Wonder on 28 Sep 2021
European Medicines Agency grants Atara Biotherapeutics accelerated assessment of tab-cel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
27 September 2021 - Atara on track to submit MAA in November 2021. ...
Posted by Michael Wonder on 27 Sep 2021
EMA evaluating data on booster dose of COVID-19 vaccine Spikevax
27 September 2021 - EMA has started evaluating an application for the use of a booster dose of Spikevax (Moderna’s ...
Posted by Michael Wonder on 24 Sep 2021
EU drugs regulator to decide on Pfizer vaccine booster in early October
23 September 2021 - The EMA aims to decide in early October whether to endorse a third dose of the ...
Posted by Michael Wonder on 21 Sep 2021
Lilly announces procurement agreement with European Commission to supply bamlanivimab and etesevimab together for the treatment of confirmed COVID-19
21 September 2021 - Joint Procurement Agreement enables European countries to purchase bamlanivimab and etesevimab directly from Lilly, in varying ...
Posted by Michael Wonder on 20 Sep 2021
EU panel rejects Pfizer’s tanezumab for osteoarthritis pain
19 September 2021 - Any lingering hope that Pfizer’s may finally get a regulatory approval for its nerve growth factor ...
Posted by Michael Wonder on 19 Sep 2021
Highlights from the CHMP 13-16 September 2021 meeting
17 September 2021 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2021 meeting. ...
Posted by Michael Wonder on 19 Sep 2021
GSK receives CHMP positive opinions recommending approval of Nucala (mepolizumab) in three additional eosinophil driven diseases
17 September 2021 - If approved in Europe, mepolizumab would be the only treatment indicated for use in four eosinophil-driven diseases. ...
Posted by Michael Wonder on 19 Sep 2021
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy for certain patients with locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)
17 September 2021 - Recommendation based on data from Phase 3 KEYNOTE-355 trial. ...
Posted by Michael Wonder on 19 Sep 2021
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with Waldenström’s macroglobulinaemia
17 September 2021 - The CHMP recommendation is based on results from the Phase 3 ASPEN trial, in which BRUKINSA ...
Posted by Michael Wonder on 18 Sep 2021
Roche receives positive CHMP opinion for Gavreto (pralsetinib) for the treatment of adults with RET fusion positive advanced non-small-cell lung cancer
17 September 2021 - If approved, Gavreto will be the first and only targeted treatment approved by the EMA that ...
Posted by Michael Wonder on 18 Sep 2021
Alvotech welcomes positive CHMP opinion for AVT02, a proposed biosimilar to Humira
17 September 2021 - Alvotech today welcomed the positive opinion of the EMA's CHMP recommending the approval of Alvotech‘s high-concentration AVT02 ...
Posted by Michael Wonder on 16 Sep 2021
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis
16 September 2021 - AbbVie today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg ...
Posted by Michael Wonder on 14 Sep 2021
EMA study reveals need for RWE framework, submission structure
14 September 2021 - The EMA has identified a need for more consistency in how real world evidence is submitted. ...