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RSS FeedPosted by Michael Wonder on 16 Oct 2022
Mirum Pharmaceuticals announces positive CHMP opinion for Livmarli (maralixibat) oral solution for cholestatic pruritus in patients with Alagille syndrome two months of age and older
14 October 2022 - CHMP opinion based on pivotal ICONIC study with more than five years of data demonstrating durable and ...
Posted by Michael Wonder on 15 Oct 2022
Highlights from the 10-13 October 2022 CHMP meeting
14 October 2022 - The EMA’s CHMP recommended 10 medicines for approval at its October 2022 meeting. ...
Posted by Michael Wonder on 15 Oct 2022
CHMP recommends conditional marketing authorisation for spesolimab as first in class treatment option for generalised pustular psoriasis flares
14 October 2022 - CHMP positive opinion is based on evidence from the EFFISAYIL® 1 trial, the largest clinical trial in ...
Posted by Michael Wonder on 15 Oct 2022
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with CLL
14 October 2022 - If approved, Brukinsa would be the only BTK inhibitor for chronic lymphocytic leukaemia in the European Union to ...
Posted by Michael Wonder on 14 Oct 2022
Novartis receives positive CHMP opinion for Pluvicto for patients with progressive, PSMA positive metastatic castration-resistant prostate cancer
14 October 2022 - Phase 3 VISION trial showed Pluvicto plus best standard of care significantly improved survival for patients with ...
Posted by Michael Wonder on 14 Oct 2022
Libtayo (cemiplimab) receives positive CHMP opinion recommending approval to treat advanced cervical cancer
14 October 2022 - Recommendation based on a Phase 3 Libtayo trial that was first and only to demonstrate significantly ...
Posted by Michael Wonder on 11 Oct 2022
Pharming submits a marketing authorisation application to the European Medicines Agency for leniolisib
11 October 2022 - Application is based on randomised, controlled and long-term extension data for leniolisib as a treatment for ...
Posted by Michael Wonder on 11 Oct 2022
EMA publishes minutes of bilateral EMA – EUnetHTA meeting (June 2022)
11 October 2022 - The chairs welcome participants to the first bilateral under the new Work Plan between EUnetHTA 21 ...
Posted by Michael Wonder on 10 Oct 2022
EMA publishes agenda for 10-13 October 2022 CHMP meeting
10 October 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 10 Oct 2022
High quality data to empower data-driven medicines regulation in the European Union
10 October 2022 - EMA and the Heads of Medicines Agencies in the EU Member States are moving ahead with ...
Posted by Michael Wonder on 04 Oct 2022
Santhera submits marketing authorisation application to the European Medicines Agency for vamorolone in Duchenne muscular dystrophy
3 October 2022 - Santhera Pharmaceuticals announces that the Company has submitted a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 30 Sep 2022
Biogen announced EMA filing acceptance of BIIB800, a biosimilar candidate referencing RoActemra (tocilizumab)
30 September 2022 - Biogen announced that the EMA has accepted the marketing authorisation application for BIIB800, a biosimilar candidate ...
Posted by Michael Wonder on 30 Sep 2022
European Medicines Agency accepts Astellas’ marketing authorisation application for fezolinetant
30 September 2022 - If authorized by the European Commission, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor ...
Posted by Michael Wonder on 23 Sep 2022
Ultomiris approved in Europe for the treatment of adults with generalised myasthenia gravis
23 September 2022 - First and only long-acting C5 inhibitor has demonstrated early onset and sustained clinical benefit, and may reduce ...
Posted by Michael Wonder on 22 Sep 2022
BridgeBio Pharma and Sentynl Therapeutics receive marketing authorisation in the EU for Nulibry (fosdenopterin) for the treatment of MOCD type A
20 September 2022 - Nulibry was BridgeBio’s first FDA approved therapeutic; Sentynl acquired global rights to Nulibry in March 2022. ...