Blog
RSS FeedPosted by Michael Wonder on 25 May 2021
European Medicines Agency grants BioMarin's request for accelerated assessment of valoctocogene roxaparvovec for treatment of severe haemophilia A
24 May 2021 - MAA resubmission on track for June 2021. ...
Posted by Michael Wonder on 25 May 2021
European Commission approves Ponvory (ponesimod) for the treatment of adults with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features
25 May 2021 - Idorsia was informed by the Janssen that the European Commission has approved Ponvory (ponesimod) for the treatment ...
Posted by Michael Wonder on 24 May 2021
Almirall receives positive CHMP opinion for Klisyri (tirbanibulin), an innovative topical treatment for actinic keratosis
21 May 2021 - Klisyri (tirbanibulin) is a novel microtubule inhibitor, indicated for the topical treatment of actinic keratosis of the ...
Posted by Michael Wonder on 24 May 2021
Libtayo (cemiplimab) receives positive CHMP opinion for the treatment in Europe of two advanced cancers
24 May 2021 - CHMP has now issued three positive opinions for Libtayo in advanced cancers. ...
Posted by Michael Wonder on 24 May 2021
Positive CHMP opinion for Ryeqo (relugolix combination tablet)
21 May 2021 - Gedeon Richter announces that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
Posted by Michael Wonder on 24 May 2021
Bristol Myers Squibb receives positive CHMP opinion recommending Opdivo (nivolumab) plus Yervoy (ipilimumab) for treatment of mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer after prior chemotherapy
21 May 2021 - Application based on positive results from the Phase 2 CheckMate-142 trial demonstrating a durable clinical benefit in ...
Posted by Michael Wonder on 23 May 2021
EU regulator backs extending approval for remdesivir for another year
21 May 2021 - The EMA on Friday recommended extending conditional marketing approval by a year for Gilead Sciences’ COVID-19 ...
Posted by Michael Wonder on 23 May 2021
Positive CHMP opinion for Bayer’s new symptomatic chronic heart failure treatment vericiguat
21 May 2021 - Vericiguat is being considered for adult patients with reduced ejection fraction who are stabilised after a recent ...
Posted by Michael Wonder on 23 May 2021
First gene therapy to treat children with rare inherited neurological disease
21 May 2021 - The EMA has recommended granting a marketing authorisation in the European Union for the gene therapy ...
Posted by Michael Wonder on 23 May 2021
New treatment for obesity caused by rare genetic disorders
21 May 2021 - EMA has recommended granting a marketing authorisation in the European Union for Imcivree (setmelanotide) to support weight ...
Posted by Michael Wonder on 23 May 2021
Pfizer and BioNTech to supply the European Union with up to 1.8 billion additional doses of Comirnaty
20 May 2021 - New agreement to supply 900 million doses to the European Commission, with option to request up to ...
Posted by Michael Wonder on 21 May 2021
EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19
21 May 2021 - EMA’s CHMP has completed its review on the use of the monoclonal antibody sotrovimab (also known as ...
Posted by Michael Wonder on 21 May 2021
Vaxzevria: further advice on blood clots and low blood platelets
21 May 2021 - EMA has provided additional advice on blood clots or low blood platelets occurring after vaccination with Vaxzevria ...
Posted by Michael Wonder on 20 May 2021
EMA, MHRA to review Vertex' Kaftrio for children with cystic fibrosis
20 May 2021 - The EMA and the MHRA have validated Vertex' applications to expand the scope of its cystic ...
Posted 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 ...