Blog
RSS FeedPosted by Michael Wonder on 09 Feb 2022
Initiation of DARWIN EU Coordination Centre advances integration of real world evidence into assessment of medicines in the EU
9 February 2022 - EMA is initiating today the establishment of the Coordination Centre for the Data Analysis and Real ...
Posted by Michael Wonder on 02 Feb 2022
New order: European cancer coalition calls for cancer treatment overhaul
2 February 2022 - Coalition urges reformation of EU wide drug research and development to drive treatment optimisation ...
Posted by Michael Wonder on 01 Feb 2022
Janssen submits marketing authorisation application to the EMA seeking approval of bispecific antibody teclistamab for the treatment of patients with relapsed or refractory multiple myeloma
31 January 2022 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a marketing authorisation application ...
Posted by Michael Wonder on 31 Jan 2022
A stronger role for EMA
31 January 2022 - The regulation reinforcing EMA’s role in crisis preparedness and management for medicinal products and medical devices has ...
Posted by Michael Wonder on 31 Jan 2022
CHMP recommends approval of Dupixent (dupilumab) for children aged 6 to 11 years with severe asthma with type 2 inflammation
31 January 2022 - Recommendation based on pivotal trial that showed Dupixent significantly reduced severe asthma attacks and improved lung function ...
Posted by Michael Wonder on 30 Jan 2022
European Commission approves Lorviqua (lorlatinib) as a first-line treatment for ALK positive advanced lung cancer
28 January 2022 - Approval based on results from Phase 3 CROWN trial, showing Lorviqua reduced risk of disease progression ...
Posted by Michael Wonder on 30 Jan 2022
Blueprint Medicines' Ayvakyt (avapritinib) receives positive CHMP opinion for the treatment of adults with advanced systemic mastocytosis
28 January 2022 - Positive opinion based on results from two clinical trials that comprise the largest clinical trial dataset in ...
Posted by Michael Wonder on 30 Jan 2022
CHMP issues positive opinion to expand Jardiance (empagliflozin) indication based on unprecedented benefit in adult heart failure patients with preserved ejection fraction
28 January 2022 - The positive opinion is based on the landmark EMPEROR-Preserved Phase 3 trial, which showed significant outcomes in ...
Posted by Michael Wonder on 28 Jan 2022
Highlights from CHMP 24-27 January 2022 meeting
28 January 2022 - EMA’s CHMP recommended seven medicines for approval at its January 2022 meeting. ...
Posted by Michael Wonder on 27 Jan 2022
COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
27 January 2022 - The EMA’s CHMP has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid ...
Posted by Michael Wonder on 25 Jan 2022
Vyepti (eptinezumab) approved by the EU Commission for the preventive treatment of migraine in adults
24 January 2022 - Vyepti is the first intravenous treatment approved for migraine prevention in Europe. ...
Posted by Michael Wonder on 24 Jan 2022
EMA publishes agenda for 24-27 Jan CHMP meeting
23 January 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 20 Jan 2022
ChemoCentryx announces EU approval of Tavneos (avacopan) for the treatment of ANCA associated vasculitis
19 January 2022 - ChemoCentryx today announced that Tavneos (avacopan) has been approved within the European Union in combination with a ...
Posted by Michael Wonder on 19 Jan 2022
FDA accepts for review Libtayo (cemiplimab-rwlc) in combination with chemotherapy for first-line treatment of advanced NSCLC
19 January 2022 - Regulatory filing recently submitted in the European Union. ...
Posted by Michael Wonder on 17 Jan 2022
Serb receives EU approval for Voraxaze (glucarpidase) as rescue therapy for high dose methotrexate toxicity
14 January 2022 - Serb and BTG Specialty Pharmaceuticals today announced that the European Commission has granted marketing authorisation for ...