Blog
RSS FeedPosted 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 29 Apr 2021
EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen
29 April 2021 - EMA has started evaluating an application to extend the use of Olumiant (baricitinib) to include treatment ...
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 28 Apr 2021
Y-mAbs submits omburtamab marketing authorisation application to the EMA
27 April 2021 - Y-mAbs Therapeutics today announced that the Company has submitted its marketing authorisation application to the European Medicines ...
Posted by Michael Wonder on 27 Apr 2021
EMA grants accelerated assessment procedure for Nefecon for the treatment of IgA nephropathy
23 April 2021 - Calliditas Therapeutics today announced that its lead product candidate Nefecon, a novel oral formulation targeting down regulation ...
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 27 Apr 2021
Karyopharm announces European Medicines Agency's validation of its type II variation marketing authorisation application for Nexpovio (selinexor) in combination with Velcade (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma
26 April 2021 - EMA regulatory decision expected in the fourth quarter of 2021. ...
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
Tagrisso recommended for approval in the EU by CHMP for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
26 April 2021 - Opinion based on unprecedented results from the ADAURA Phase 3 trial where Tagrisso reduced the risk of ...
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. ...