Blog
RSS FeedPosted by Michael Wonder on 31 Oct 2020
European Medicines Agency accepts Biogen’s aducanumab marketing authorisation application for Alzheimer's disease
30 October 2020 - If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and ...
Posted by Michael Wonder on 31 Oct 2020
Extra transparency measures for COVID-19 vaccines and therapeutics
30 October 2020 - Today the EMA has implemented two further extra transparency measures for COVID-19 medicines, by publishing both ...
Posted by Michael Wonder on 29 Oct 2020
European Patent Office rules in favour of Sanofi and Regeneron concerning Praluent (alirocumab)
29 October 2020 - Ruling invalidates Amgen’s European patent claims directed to PCSK9 antibodies relevant to Praluent (alirocumab). ...
Posted by Michael Wonder on 29 Oct 2020
European Commission grants marketing authorisation for Arikayce liposomal 590 mg nebuliser dispersion for the treatment of NTM lung infections caused by MAC in adult non-CF patients with limited treatment options
28 October 2020 - Arikayce is the first and only therapy approved in both the European Union and United States for ...
Posted by Michael Wonder on 28 Oct 2020
Sanofi and GSK to support COVAX with 200 million doses of adjuvanted, recombinant protein based COVID-19 vaccine
28 October 2020 - COVAX Facility is led by Gavi and aims to secure successful and equitable access to COVID-19 vaccines ...
Posted by Michael Wonder on 27 Oct 2020
FDA grants priority review and EMA accepts regulatory submission for Pfizer's abrocitinib, an oral once daily JAK1 inhibitor, for patients 12 and up with moderate to severe atopic dermatitis
27 October 2020 - Filings based on robust abrocitinib clinical trial data demonstrating significant symptom improvement versus placebo as well as ...
Posted by Michael Wonder on 27 Oct 2020
Information specialist collaboration in Europe: collaborative methods, processes, and infrastructure through EUnetHTA
21 October 2020 - The history of European health technology assessment goes back more than 30 years. Almost as old as ...
Posted by Michael Wonder on 26 Oct 2020
European Union would apply lower threshold in assessing COVID-19 vaccine
25 October 2020 - The EU’s drug regulator is willing to approve a vaccine even if it were effective in less ...
Posted by Michael Wonder on 23 Oct 2020
Strengthening global collaboration on COVID-19 real-world evidence and observational studies
23 October 2020 - Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate ...
Posted by Michael Wonder on 19 Oct 2020
Bristol Myers Squibb receives positive CHMP opinion recommending Opdivo (nivolumab) as second-line treatment for unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
16 October 2020 - Application based on Phase 3 ATTRACTION-3 trial demonstrating a statistically significant and clinically meaningful improvement in patients’ ...
Posted by Michael Wonder on 19 Oct 2020
Agios announces withdrawal of European marketing authorisation application for Tibsovo as a treatment for relapsed or refractory IDH1 mutant acute myeloid leukaemia
16 October 2020 - Agios continues to advance two Phase 3 combination trials of Tibsovo in newly diagnosed AML patients. ...
Posted by Michael Wonder on 19 Oct 2020
AbbVie submits regulatory applications to FDA and EMA for Rinvoq (upadacitinib) in atopic dermatitis
19 October 2020 - In three pivotal Phase 3 studies, Rinvoq met co-primary and all secondary endpoints in adult and adolescent ...
Posted by Michael Wonder on 19 Oct 2020
EMA virtual conference: 25 years of advancing public and animal health
19 October 2020 - On 22 October 2020, EMA will mark 25 years of its strong commitment to protect public ...
Posted by Michael Wonder on 19 Oct 2020
Janssen receives CHMP positive opinion for expanded use of Tremfya (guselkumab) in the treatment of active psoriatic arthritis in the European Union
16 October 2020 - If approved, guselkumab will be the first selective interleukin 23 p19 sub-unit inhibitor licensed for both ...
Posted by Michael Wonder on 19 Oct 2020
Aimmune receives positive CHMP opinion on Palforzia for the treatment of patients with peanut allergy in Europe
16 October 2020 - Final European Commission Decision on Marketing Approval Anticipated in Q4 2020. ...