Blog
RSS FeedPosted by Michael Wonder on 05 Apr 2022
Bristol Myers Squibb receives European Commission approval for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for certain forms of relapsed or refractory large B-cell lymphoma
5 April 2022 - Approval of Breyanzi is based on results from TRANSCEND WORLD, and TRANSCEND NHL 001, the largest pivotal ...
Posted by Michael Wonder on 05 Apr 2022
European Commission approves Kimmtrak (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
4 April 2022 - Kimmtrak demonstrated statistically and clinically meaningful overall survival benefit, hazard ratio of 0.51, with median overall ...
Posted by Michael Wonder on 04 Apr 2022
Novartis announces European Commission approval of Beovu for people living with diabetic macular oedema
31 March 2022 - Approval is based on year one data from the Phase 3 KESTREL and KITE trials investigating Beovu ...
Posted by Michael Wonder on 04 Apr 2022
Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
1 April 2022 - Celerity Pharmaceuticals Uses Biocon Biologics’ Insulin Drug Substance to Develop the Product. ...
Posted 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 ...