Blog
RSS FeedPosted by Michael Wonder on 20 May 2022
Novartis Cosentyx (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions
20 May 2022 - Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in paediatric enthesitis-related arthritis ...
Posted by Michael Wonder on 20 May 2022
CHMP recommends approval of Lilly and Incyte's Olumiant (baricitinib) as the first and only centrally authorised treatment for adults with severe alopecia areata
20 May 2022 - Eli Lilly and Incyte announced today that the EMA's CHMP has issued a positive opinion for ...
Posted by Michael Wonder on 20 May 2022
Highlights from the 16-19 May 2022 CHMP meeting
20 May 2022 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its May 2022 meeting. ...
Posted by Michael Wonder on 20 May 2022
Mirati Therapeutics submits marketing authorisation application to the European Medicines Agency for investigational adagrasib as a treatment for previously treated KRASG12C mutated non-small-cell lung cancer
19 May 2022 - Submission follows the U.S. FDA acceptance of the adagrasib new drug application for the same indication ...
Posted by Michael Wonder on 16 May 2022
EMA publishes agenda for 16-19 May 2022 CHMP meeting
16 May 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 05 May 2022
Novartis receives European Commission approval for Jakavi to be the first post-steroid treatment for acute and chronic graft versus host disease
5 May 2022 - Jakavi is the first JAK1/2 inhibitor available for patients in Europe who previously had no approved therapies ...
Posted by Michael Wonder on 04 May 2022
European Commission approves Cabometyx as a second-line treatment for people living with radioactive iodine-refractory differentiated thyroid cancer
3 May 2022 - Approval based on data from the COSMIC-311 Phase 3 trial, in which Cabometyx (cabozantinib) demonstrated a 78% ...
Posted by Michael Wonder on 02 May 2022
Myovant Sciences announces European Commission approval for Orgovyx (relugolix) for the treatment of advanced hormone sensitive prostate cancer
29 April 2022 - Myovant expects to secure European commercialisation partner ahead of anticipated launches. ...
Posted by Michael Wonder on 28 Apr 2022
Janssen submits marketing authorisation application to EMA seeking approval of niraparib and abiraterone acetate dual action tablet plus prednisone for the treatment of patients with HRR gene mutated metastatic castration resistant prostate cancer
28 April 2022 - The submission to the EMA is based on results from the Phase 3 MAGNITUDE study evaluating niraparib ...
Posted by Michael Wonder on 27 Apr 2022
Pfizer and Biohaven's Vydura (rimegapant) granted first ever marketing authorisation by European Commission for both acute treatment of migraine and prophylaxis of episodic migraine
27 April 2022 - Pfizer and Biohaven Pharmaceutical today announced that the European Commission has granted marketing authorisation for Vydura (rimegepant), ...
Posted by Michael Wonder on 27 Apr 2022
European Medicines Agency grants PRIME designation to BioCryst’s ALK-2 inhibitor, BCX9250, for treatment of fibrodysplasia ossificans progressiva
27 April 2022 - BCX9250 is first investigational drug for FOP to be eligible for program. ...
Posted by Michael Wonder on 26 Apr 2022
ObsEva announces confirmation of positive CHMP opinion for linzagolix, an oral GnRH antagonist, for the treatment of uterine fibroids
25 April 2022 - ObsEva today announced that the CHMP of the EMA has confirmed its previously adopted positive opinion, ...
Posted by Michael Wonder on 24 Apr 2022
Update on regulatory submission for aducanumab in the European Union
22 April 2022 - Biogen has notified the EMA of its decision to withdraw its marketing authorisation application for aducanumab for ...
Posted by Michael Wonder on 24 Apr 2022
CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment for a subset of people with early-stage non-small-cell lung cancer
22 April 2022 - In the Phase III IMpower010 trial, adjuvant Tecentriq reduced the risk of disease recurrence or death by ...
Posted by Michael Wonder on 24 Apr 2022
CHMP adopts positive opinion for Filsuvez for the treatment of dystrophic and junctional EB
22 April 2022 - Positive opinion based on largest ever pivotal global Phase 3 EASE trial undertaken in epidermolysis bullosa. ...