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RSS FeedPosted by Michael Wonder on 16 Sep 2023
EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
15 September 2023 - EMA’s human medicines committee (CHMP) has recommended not renewing the marketing authorisation for Translarna (ataluren), a ...
Posted by Michael Wonder on 16 Sep 2023
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) as adjuvant treatment for adults with non-small cell lung cancer at high risk of recurrence following complete resection and platinum-based chemotherapy
15 September 2023 - Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial. ...
Posted by Michael Wonder on 16 Sep 2023
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor for children with cystic fibrosis ages 2 through 5
15 September 2023 - If approved, more than 1,200 children would be newly eligible for a medicine that could treat ...
Posted by Michael Wonder on 15 Sep 2023
Enhertu recommended for approval in the EU by CHMP for patients with HER2 mutant advanced non-small cell lung cancer
15 September 2023 - Recommendation based on DESTINY-Lung02 trial results which showed AstraZeneca and Daiichi Sankyo’s Enhertu achieved strong and durable ...
Posted by Michael Wonder on 15 Sep 2023
UCB receives CHMP positive opinion of zilucoplan for the treatment of adults with generalized myasthenia gravis in Europe
15 September 2023 - The CHMP positive opinion is based on the pivotal Phase 3 RAISE study in generalised myasthenia gravis ...
Posted by Michael Wonder on 14 Sep 2023
Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
14 September 2023 - EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 ...
Posted by Michael Wonder on 10 Sep 2023
European Commission expands Merck’s Ervebo [Ebola Zaire vaccine, live] indication to include children 1 year of age and older
7 September 2023 - Milestone signifies on-going effort to help prepare for outbreaks of Zaire ebolavirus. ...
Posted by Michael Wonder on 05 Sep 2023
SK Bioscience withdraws conditional marketing authorisation for COVID-19 vaccine in EU
4 September 2023 - SK Bioscience said it has voluntarily withdrawn its application for a conditional marketing authorisation license to ...
Posted by Michael Wonder on 30 Aug 2023
EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
30 August 2023 - The EMA’s CHMP has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant. ...
Posted by Michael Wonder on 30 Aug 2023
European Commission approves Roche’s Evrysdi for babies under two months old with spinal muscular atrophy
29 August 2023 - Approval is based on interim data from ongoing RAINBOWFISH trial showing majority of Evrysdi-treated babies were able ...
Posted by Michael Wonder on 30 Aug 2023
European Commission approves Keytruda (pembrolizumab) plus trastuzumab and chemotherapy as first-line treatment for HER2 positive advanced gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)
29 August 2023 - Approval based on progression-free survival benefit demonstrated in Phase 3 KEYNOTE-811 trial. ...
Posted by Michael Wonder on 25 Aug 2023
European Commission approves Pfizer’s Abrysvo to help protect infants through maternal immunisation and older adults from RSV
24 August 2023 - Abrysvo is the first and only RSV vaccine approved in the European Union for both older ...
Posted by Michael Wonder on 23 Aug 2023
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma
22 August 2023 - Approval based on results from the Phase 3 CheckMate-76K trial in patients with stage IIB or ...
Posted by Michael Wonder on 21 Aug 2023
European Commission approves reduced dosing frequency for Janssen’s bispecific antibody Tecvayli (teclistamab)
18 August 2023 - Teclistamab, the first BCMA-targeting bispecific antibody to receive approval in Europe, maintained deep and durable responses, with ...
Posted by Michael Wonder on 17 Aug 2023
AbbVie announces European Commission approval of Aquipta (atogepant) for the preventive treatment of migraine in adults
17 August 2023 - Approval is based on two pivotal Phase 3 studies that demonstrated statistically significant reduction in mean ...