Blog
RSS FeedPosted by Michael Wonder on 26 Jun 2022
CHMP issues a positive opinion recommending full approval of Oncopeptides Pepaxti in EU for patients with triple class refractory multiple myeloma
23 June 2022 - Oncopeptides today announces that the EMA's CHMP, has unanimously adopted a positive opinion recommending a full marketing ...
Posted by Michael Wonder on 26 Jun 2022
argenx receives positive CHMP opinion for efgartigimod for the treatment of adult patients with generalised myasthenia gravis in Europe
24 June 2022 - Positive opinion based on Phase 3 ADAPT trial showing efgartigimod provided clinically meaningful improvements in strength and ...
Posted by Michael Wonder on 26 Jun 2022
First gene therapy to treat severe haemophilia A
24 June 2022 - EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) ...
Posted by Michael Wonder on 26 Jun 2022
Highlights from the 20-23 June 2022 CHMP meeting
24 June 2022 - EMA’s CHMP recommended nine medicines for approval at its June 2022 meeting. ...
Posted by Michael Wonder on 26 Jun 2022
Investigational lenacapavir receives positive CHMP opinion for people with multi-drug resistant HIV
24 June 2022 - Recommendation is based on week 26 data from the CAPELLA trial showing twice yearly lenacapavir achieved high ...
Posted by Michael Wonder on 25 Jun 2022
Novartis receives positive CHMP opinion for Scemblix, a novel treatment for adult patients with chronic myeloid leukaemia
24 June 2022 - ...
Posted by Michael Wonder on 24 Jun 2022
European Commission approves Filsuvez for the treatment of dystrophic and junctional epidermolysis bullosa
23 June 2022 - Filsuvez will be the first and only approved treatment for epidermolysis bullosa patients. ...
Posted by Michael Wonder on 23 Jun 2022
EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU
23 June 2022 - EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in ...
Posted by Michael Wonder on 23 Jun 2022
EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
23 June 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use ...
Posted by Michael Wonder on 23 Jun 2022
Novartis receives European Commission approval for Tabrecta for the treatment of METex14 skipping advanced non-small cell lung cancer
22 June 2022 - Approval based on the Phase II GEOMETRY mono-1 trial, which showed an overall response rate of 51.6% ...
Posted by Michael Wonder on 11 Jun 2022
FDA approves new oncology drugs quicker than EMA
10 June 2022 - The US FDA is quicker to approve new oncology drugs compared with the EMA, according to ...
Posted by Michael Wonder on 09 Jun 2022
Bydureon BCise (exenatide prolonged-release) approved in the EU for paediatric patients with type 2 diabetes
8 June 2022 - First once weekly GLP-1 treatment option for paediatric patients with type-2 diabetes in the EU. ...
Posted by Michael Wonder on 08 Jun 2022
European Commission approves Roche’s first-in-class bispecific antibody Lunsumio for people with relapsed or refractory follicular lymphoma
8 June 2022 - Approval is based on the phase I/II GO29781 study, where Lunsumio induced high complete response rates, with ...
Posted by Michael Wonder on 27 May 2022
Carvykti (ciltacabtagene autoleucel) granted conditional approval by the European Commission for the treatment of patients with relapsed and refractory multiple myeloma
26 May 2022 - The approval is based on the pivotal Phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate ...
Posted by Michael Wonder on 26 May 2022
European Commission approves Keytruda (pembrolizumab) plus chemotherapy as neo-adjuvant treatment, then continued as adjuvant monotherapy after surgery for locally advanced or early stage triple negative breast cancer at high risk of recurrence
24 May 2022 - Approval based on event-free survival benefit demonstrated in Phase 3 KEYNOTE-522 trial. ...