Blog
RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 18 Jan 2022
COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy
18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...
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 ...
Posted by Michael Wonder on 16 Jan 2022
Ascendis Pharma receives European Approval for TransCon hGH for paediatric growth hormone deficiency
13 January 2022 - TransCon hGH (approved by the European Commission as Lonapegsomatropin Ascendis Pharma) is a once-weekly prodrug of somatropin ...
Posted by Michael Wonder on 16 Jan 2022
Accelerating clinical trials in the EU: for better clinical trials that address patients’ need
13 January 2022 - Today, the European Commission, the Heads of Medicines Agencies and the EMA have launched an initiative to ...
Posted by Michael Wonder on 16 Jan 2022
Global regulators discuss path towards regulatory alignment on response to Omicron variant
13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...
Posted by Michael Wonder on 11 Jan 2022
Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant
11 January 2022 - EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused ...
Posted by Michael Wonder on 11 Jan 2022
European Commission approves Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat children with cystic fibrosis ages 6 to 11 years
11 January 2022 - More than 1,500 children now eligible to receive a treatment targeting the underlying cause of cystic ...