Blog
RSS FeedPosted 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
Medicines regulator pilot probes pharma delays in market launches
25 January 2022 - The European Medicines Agency wants to get a better understanding of drug companies’ commercial intentions and why. ...
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 29 Jan 2022
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory DLBCL, PMBCL and FL3B
28 January 2022 - Recommendation for approval based on results from TRANSCEND NHL 001, the largest pivotal trial of patients ...
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
Regulatory harmonisation of clinical trials in the EU: clinical trials regulation to enter into application and new clinical trials information system to be launched
25 January 2022 - On 31 January 2022, the clinical trials regulation will come into application harmonising the submission, assessment and ...
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 21 Jan 2022
International regulators’ recommendations on COVID-19 vaccines and the Omicron variant
21 January 2022 - International regulators have published a report today highlighting their discussions on the effectiveness of current vaccines against ...
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 ...