Blog
RSS FeedPosted by Michael Wonder on 28 Mar 2022
Blueprint Medicines' Ayvakyt (avapritinib) receives European Commission approval for the treatment of adults with advanced systemic mastocytosis
25 March 2022 - Initial commercial launch is planned for Germany immediately following the European Commission approval. ...
Posted by Michael Wonder on 28 Mar 2022
Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis of COVID-19 in a broad population
28 March 2022 - Evusheld retains neutralising activity against the Omicron BA.2 subvariant, now the dominant strain in Europe ...
Posted by Michael Wonder on 25 Mar 2022
Highlights from the CHMP 21-24 March 2022 meeting
25 March 2022 - The EMA’s CHMP recommended five medicines for approval at its March 2022 meeting. ...
Posted by Michael Wonder on 25 Mar 2022
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) for patients with microsatellite instability-high or mismatch repair deficient tumours in five different types of cancer
25 March 2022 - Recommendation supports use of Keytruda for certain patients with unresectable or metastatic MSI-H/dMMR colorectal, gastric, small ...
Posted by Michael Wonder on 25 Mar 2022
Ipsen receives positive CHMP opinion for Cabometyx in radioactive iodine-refractory differentiated thyroid cancer
25 March 2022 - Recommendation based on data from the COSMIC-311 Phase 3 trial, in which Cabometyx (cabozantinib) demonstrated a 78% ...
Posted by Michael Wonder on 25 Mar 2022
Novartis receives positive CHMP opinion for Kymriah CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma in Europe
25 March 2022 - CHMP opinion based on Phase 2 global ELARA trial demonstrating high response rates in heavily pretreated patients; ...
Posted by Michael Wonder on 25 Mar 2022
CHMP recommends EU approval of Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma
25 March 2022 - Recommendation is based on pivotal data from the Phase 3 POLARIX trial. ...
Posted by Michael Wonder on 25 Mar 2022
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus chemotherapy, with or without bevacizumab, as treatment for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1 (CPS ≥1)
25 March 2022 - Opinion granted based on positive results from Phase 3 KEYNOTE-826 trial. ...
Posted by Michael Wonder on 25 Mar 2022
Novartis receives positive CHMP opinion for Jakavi to treat acute and chronic graft versus host disease
25 March 2022 - CHMP opinion based on Phase 3 REACH2 and REACH3 trials that showed Jakavi improved response rates and ...
Posted by Michael Wonder on 25 Mar 2022
New gene therapy to treat adult patients with multiple myeloma
25 March 2022 - EMA has recommended a conditional marketing authorisation in the European Union for Carvykti (ciltacabtagene autoleucel) for the ...
Posted by Michael Wonder on 24 Mar 2022
Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis of COVID-19
24 March 2022 - Recommendation based on Phase 3 PROVENT trial showing a significant reduction in the risk of developing ...
Posted by Michael Wonder on 07 Mar 2022
Jardiance (empagliflozin) becomes the first and only approved treatment in Europe for adults with symptomatic chronic heart failure regardless of ejection fraction
7 March 2022 - The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with ...
Posted by Michael Wonder on 01 Mar 2022
CHMP recommends Idorsia’s dual acting treatment Quviviq for insomnia patients
28 February 2022 - Quviviq can be used on a long-term basis, addressing a key limitation of existing therapies ...
Posted by Michael Wonder on 01 Mar 2022
Glucophage is the first oral diabetes treatment approved in Europe for use during pregnancy
28 February 2022 - The approval was granted on the basis of Merck’s own safety cohort study CLUE and a large ...
Posted by Michael Wonder on 28 Feb 2022
Astellas and Seagen announce CHMP confirms positive opinion for Padcev (enfortumab vedotin) in locally advanced or metastatic urothelial cancer
28 February 2022 - Astellas Pharma and Seagen today announced that the CHMP of the EMA has confirmed its previously ...