Blog
RSS FeedPosted by Michael Wonder on 20 May 2021
NICE turns down Janssen's Erleada
20 May 2021 - NICE has published draft guidance rejecting Janssen's Erleada (apalutamide) with androgen deprivation therapy for treating prostate ...
Posted by Michael Wonder on 10 May 2021
Positive CHMP opinion for self-administered Crysvita
10 May 2021 - The EMA's CHMP has recommended Kyowa Kirin’s Crysvita for a new self-administration option to treat the ...
Posted by Michael Wonder on 06 May 2021
European Commission approves Benlysta for adult patients with active lupus nephritis
5 May 2021 - First and only biologic approved for both systemic lupus erythematosus and lupus nephritis ...
Posted by Michael Wonder on 05 May 2021
Roche’s Tecentriq approved by European Commission as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer
5 May 2021 - This approval marks Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung ...
Posted by Michael Wonder on 04 May 2021
Astellas' Xtandi (enzalutamide) approved by European Commission for men with metastatic hormone sensitive prostate cancer
4 May 2021 - Enzalutamide is now the only oral therapy approved by the European Commission to treat three distinct types ...
Posted by Michael Wonder on 03 May 2021
BioCryst receives European Commission approval of Orladeyo (berotralstat), first oral, once daily therapy to prevent attacks in hereditary angioedema patients
30 April 2021 - BioCryst Pharmaceuticals today announced that the European Commission has approved oral, once daily Orladeyo (berotralstat) for ...
Posted by Michael Wonder on 28 Apr 2021
Vertex announces European Commission approval for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat cystic fibrosis patients 12 years and older with at least one F508del mutation in the CFTR gene
28 April 2021 - New indication includes people ages 12 years and older who have one copy of the F508del mutation ...
Posted by Michael Wonder on 27 Apr 2021
Glenmark’s Ryaltris nasal spray now approved in Europe for the first-line treatment of allergic rhinitis in patients over 12 years of age
26 April 2021 - This marks Glenmark’s first innovative product approval in the European Union. ...
Posted by Michael Wonder on 26 Apr 2021
Selumetinib recommended for approval in the EU by CHMP as the first medicine for paediatric patients with neurofibromatosis type 1 and plexiform neurofibromas
26 April 2021 - Recommendation based on the SPRINT Phase 2 trial, which showed selumetinib reduced tumour volume in children. ...
Posted by Michael Wonder on 26 Apr 2021
European Commission approves GSK’s Jemperli (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer
23 April 2021 - The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe. ...
Posted by Michael Wonder on 26 Apr 2021
LEO Pharma receives positive CHMP opinion of Adtralza (tralokinumab) for the treatment of adults with moderate-to-severe atopic dermatitis
23 April 2021 - The CHMP opinion is primarily supported by data from ECZTRA 1, 2, and 3 trials included in ...
Posted by Michael Wonder on 26 Apr 2021
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) as first-line treatment for unresectable malignant pleural mesothelioma
23 April 2021 - Recommendation based on positive results from the Phase 3 CheckMate-743 trial, in which Opdivo plus Yervoy demonstrated ...
Posted by Michael Wonder on 26 Apr 2021
Bristol Myers Squibb receives positive CHMP opinion for Onureg (azacitidine tablets; CC-486) as frontline oral maintenance therapy for adults with acute myeloid leukaemia in first remission
23 April 2021 - In the pivotal Quazar AML-001 study, Onureg demonstrated significant overall survival and showed a relapse-free survival benefit ...
Posted by Michael Wonder on 25 Apr 2021
AbbVie receives positive CHMP opinion for Venclyxto (venetoclax) as a combination regimen for adult patients with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy
23 April 2021 - Positive opinion based on data from the VIALE-A and M14-358 trials, which evaluated the safety, efficacy and ...
Posted by Michael Wonder on 24 Apr 2021
Highlights from the April 19-22 CHMP meeting
23 April 2021 - EMA’s CHMP recommended eight medicines for approval at its April 2021 meeting. ...