Blog
RSS FeedPosted by Michael Wonder on 20 Jun 2022
EFPIA and Vaccines Europe are deeply disappointed about the decision taken by World Trade Organization at the Ministerial Conference to endorse a TRIPS waiver for COVID-19 vaccines
17 June 2022 - Speaking about the waiver, EFPIA Director General, Nathalie Moll said. “The decision is a serious retrograde step ...
Posted by Michael Wonder on 19 Jun 2022
Start of rolling review for adapted Spikevax COVID-19 vaccine
17 June 2022 - EMA has started a rolling review for a version of Spikevax adapted to provide better protection ...
Posted by Michael Wonder on 17 Jun 2022
Sandoz application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA
17 June 2022 - Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study. ...
Posted by Michael Wonder on 15 Jun 2022
Start of rolling review for adapted Comirnaty COVID-19 vaccine
15 June 2022 - EMA has started a rolling review for a version of Comirnaty adapted to provide better protection ...
Posted by Michael Wonder on 11 Jun 2022
FDA approves new oncology drugs quicker than EMA
10 June 2022 - The US FDA is quicker to approve new oncology drugs compared with the EMA, according to ...
Posted by Michael Wonder on 09 Jun 2022
Bydureon BCise (exenatide prolonged-release) approved in the EU for paediatric patients with type 2 diabetes
8 June 2022 - First once weekly GLP-1 treatment option for paediatric patients with type-2 diabetes in the EU. ...
Posted by Michael Wonder on 08 Jun 2022
European Commission approves Roche’s first-in-class bispecific antibody Lunsumio for people with relapsed or refractory follicular lymphoma
8 June 2022 - Approval is based on the phase I/II GO29781 study, where Lunsumio induced high complete response rates, with ...
Posted by Michael Wonder on 08 Jun 2022
EMA adopts first list of critical medicines for COVID-19
8 June 2022 - On 7 June 2022, the EMA’s Medicines Shortages Steering Group adopted the list of critical medicines for ...
Posted by Michael Wonder on 08 Jun 2022
Vertex announces inaxaplin (VX-147) granted breakthrough therapy designation by U.S. FDA and PRIME designation by the EMA
8 June 2022 - Vertex granted nine breakthrough therapy designations and three PRIME designations across its pipeline programs to date. ...
Posted by Michael Wonder on 07 Jun 2022
Sifi announces EMA validation of its marketing authorisation application for Akantior for the treatment of acanthamoeba keratitis
7 June 2022 - Sifi has launched an early access program across European countries in June 2022. ...
Posted by Michael Wonder on 01 Jun 2022
EMA appoints Chief Medical Officer
1 June 2022 - Steffen Thirstrup has been appointed as Chief Medical Officer of the EMA. ...
Posted by Michael Wonder on 27 May 2022
Carvykti (ciltacabtagene autoleucel) granted conditional approval by the European Commission for the treatment of patients with relapsed and refractory multiple myeloma
26 May 2022 - The approval is based on the pivotal Phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate ...
Posted by Michael Wonder on 26 May 2022
European Commission approves Keytruda (pembrolizumab) plus chemotherapy as neo-adjuvant treatment, then continued as adjuvant monotherapy after surgery for locally advanced or early stage triple negative breast cancer at high risk of recurrence
24 May 2022 - Approval based on event-free survival benefit demonstrated in Phase 3 KEYNOTE-522 trial. ...
Posted by Michael Wonder on 26 May 2022
Roche’s Polivy combination approved by European Commission for people with previously untreated diffuse large B-cell lymphoma
25 May 2022 - Approval is based on pivotal data from the Phase 3 POLARIX study, where Polivy plus R-CHP significantly ...
Posted by Michael Wonder on 24 May 2022
EMA guidance supports development of new antibiotics
24 May 2022 - As part of its efforts to support a global approach to the development of new antimicrobial medicines, ...