Blog
RSS FeedPosted by Michael Wonder on 23 Jul 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for LAG-3-blocking antibody combination Opdualag (nivolumab and relatlimab) for treatment of patients with unresectable or metastatic melanoma
22 July 2022 - Recommendation based on results from the Phase 2/3 RELATIVITY-047 trial, in which the fixed-dose combination of the ...
Posted by Michael Wonder on 23 Jul 2022
Alnylam receives positive CHMP opinion for vutrisiran for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy
22 July 2022 - Positive opinion based on HELIOS-A Phase 3 study. ...
Posted by Michael Wonder on 23 Jul 2022
New medicine for multiple myeloma patients with limited treatment options
22 July 2022 - The EMA has recommended a conditional marketing authorisation in the European Union for Tecvayli (teclistamab) for ...
Posted by Michael Wonder on 23 Jul 2022
EMA recommends approval of Imvanex for the prevention of monkeypox disease
22 July 2022 - The EMA’s has recommended extending the indication of the smallpox vaccine Imvanex to include protecting adults ...
Posted by Michael Wonder on 22 Jul 2022
EMA recommends restricting use of cancer medicine Rubraca
22 July 2022 - EMA’s human medicines committee, CHMP, has recommended that Rubraca (rucaparib camsylate) should no longer be used ...
Posted by Michael Wonder on 22 Jul 2022
Upstaza granted marketing authorisation by European Commission as first disease-modifying treatment for AADC deficiency
20 July 2022 - PTC Therapeutics to launch first gene therapy directly administered into the brain. ...
Posted by Michael Wonder on 22 Jul 2022
Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
20 July 2022 - EMA has endorsed a joint statement calling for international collaboration to enable the generation and use ...
Posted by Michael Wonder on 21 Jul 2022
Karyopharm and Menarini receive full marketing authorisation from the European Commission for Nexpovio (selinexor) for the treatment of patients with multiple myeloma after at least one prior therapy
21 July 2022 - Based on Results from Phase 3 BOSTON Study, Marketing Authorisation Expands Multiple Myeloma Indication. ...
Posted by Michael Wonder on 20 Jul 2022
Pfizer and BioNTech complete submission to European Medicines Agency for Omicron BA.1 adapted bivalent vaccine candidate
19 July 2022 - Pfizer and BioNTech today announced they have completed a submission to the EMA for an Omicron-adapted bivalent ...
Posted by Michael Wonder on 19 Jul 2022
Genmab announces that AbbVie will submit marketing authorisation application to EMA for epcoritamab for the treatment of relapsed/refractory diffuse large B-cell lymphoma
18 July 2022 - Genmab today announced that AbbVie will submit a conditional marketing authorisation application with the EMA for ...
Posted by Michael Wonder on 19 Jul 2022
Enhertu approved in the EU for patients with HER2 positive metastatic breast cancer treated with one or more prior anti-HER2 based regimens
19 July 2022 - Based on groundbreaking DESTINY-Breast03 results in which Enhertu demonstrated a 72% reduction in the risk of ...
Posted by Michael Wonder on 19 Jul 2022
EMA publishes agenda for 18-21 July 2022 CHMP meeting
18 July 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 19 Jul 2022
EU regulator reviews Pfizer-BioNTech COVID shot in children as young as 6 months
18 July 2022 - The European Medicines Agency on Monday started reviewing a low-dose version of BioNTech and Pfizer’s COVID-19 ...
Posted by Michael Wonder on 18 Jul 2022
EMA validates marketing authorisation application for trastuzumab duocarmazine (SYD985) in HER2 positive metastatic breast cancer
18 July 2022 - Submission follows positive results of Phase 3 TULIP trial. ...
Posted by Michael Wonder on 18 Jul 2022
Everest Medicines announces European Commission grants approval of Kinpeygo for adults with primary IgA nephropathy to our partner Calliditas Therapeutics
17 July 2022 - Kinpeygo (developed under the name Nefecon) is the first and only EMA approved treatment for IgAN. ...