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
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 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 23 Mar 2022
Orphazyme announces withdrawal of European marketing authorisation application for arimoclomol for the treatment of Niemann-Pick disease type C
22 March 2022 - Decision to withdraw the European marketing authorisation application comes ahead of scheduled final vote on the ...
Posted by Michael Wonder on 21 Mar 2022
EMA publishes agenda for 21-24 March CHMP meeting
21 March 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 16 Mar 2022
Europe begins reviewing application for AstraZeneca COVID drug
15 March 2022 - Europe's drug regulator said on Tuesday it had begun reviewing AstraZeneca's application for antibody based COVID-19 therapy, ...
Posted by Michael Wonder on 15 Mar 2022
Drug industry says EMA’s PRIME scheme useful but could be improved
14 March 2022 - Eligibility criteria for admission to the EMA's priority medicines (PRIME) scheme are too strict to facilitate ...
Posted by Michael Wonder on 11 Mar 2022
Janssen seeks approval of a new indication for Imbruvica (ibrutinib) for use in patients with untreated mantle cell lymphoma
8 March 2022 - Application based on Phase 3 SHINE study results, which investigated the safety and efficacy of all-oral ...
Posted by Michael Wonder on 10 Mar 2022
Servier submits a marketing authorisation application to the EMA for Tibsovo (ivosidenib) for patients with IDH1 mutated acute myeloid leukaemia and cholangiocarcinoma
10 March 2022 - The submission covers countries of the European Union as well as Iceland, Liechtenstein and Norway. ...