Blog
RSS FeedPosted by Michael Wonder on 25 Apr 2021
AbbVie receives positive CHMP opinion for Venclyxto (venetoclax) as a combination regimen for adult patients with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy
23 April 2021 - Positive opinion based on data from the VIALE-A and M14-358 trials, which evaluated the safety, efficacy and ...
Posted by Michael Wonder on 24 Apr 2021
Highlights from the April 19-22 CHMP meeting
23 April 2021 - EMA’s CHMP recommended eight medicines for approval at its April 2021 meeting. ...
Posted by Michael Wonder on 24 Apr 2021
AstraZeneca’s COVID-19 vaccine: benefits and risks in context
23 April 2021 - Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) is authorised in the EU to prevent COVID-19, which can cause ...
Posted by Michael Wonder on 24 Apr 2021
CHMP recommends EU approval of Roche’s Enspryng (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder
23 April 2021 - Recommendation is based on results from the two pivotal Phase 3 SAkuraStar and SAkuraSky trials, in which ...
Posted by Michael Wonder on 23 Apr 2021
Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderns
23 April 2021 - EMA’s human medicines committee (CHMP) has adopted two important recommendations that will increase manufacturing capacity and supply ...
Posted by Michael Wonder on 22 Apr 2021
WHO and EMA to inspect Sputnik V manufacturing in May
22 April 2021 - Technical experts from the World Health Organization are due to start the next round of their ...
Posted by Michael Wonder on 21 Apr 2021
J&J resumes roll-out of COVID-19 vaccine in EU
21 April 2021 - Johnson & Johnson is planning to resume the roll-out of its COVID-19 vaccine in the EU ...
Posted by Michael Wonder on 21 Apr 2021
Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation
21 April 2021 - EMA’s Management Board confirmed that the clinical trial EU Portal and Database, one of the main deliverables ...
Posted by Michael Wonder on 21 Apr 2021
GW Pharmaceuticals receives European Commission approval for Epidyolex (cannabidiol) for the treatment of seizures associated with tuberous sclerosis complex
20 April 2021 - Tuberous sclerosis complex represents a third indication for GW’s cannabidiol in Europe. ...
Posted by Michael Wonder on 20 Apr 2021
COVID-19 vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
20 April 2021 - EMA confirms overall benefit-risk remains positive ...
Posted by Michael Wonder on 20 Apr 2021
Pfizer and BioNTech to supply the European Union with 100 million additional doses of Comirnaty
19 April 2021 - European Union exercises option under previous agreement to order 100 million additional doses of Comirnaty, bringing total ...
Posted by Michael Wonder on 19 Apr 2021
European Commission approves second indication of Sarclisa (isatuximab) for relapsed multiple myeloma
19 April 2021 - Approval based on Phase 3 IKEMA study demonstrating Sarclisa added to standard of care carfilzomib and dexamethasone ...
Posted by Michael Wonder on 17 Apr 2021
Oncopeptides submits application for conditional marketing authorisation of melflufen in the EU
16 April 2021 - Oncopeptides today announces that the Company has submitted an application to the EMA for conditional marketing authorisation ...
Posted by Michael Wonder on 15 Apr 2021
EU drug regulator to issue view on J&J vaccine next week
15 April 2021 - Europe's drug regulator said on Wednesday it planned to issue a recommendation on Johnson & Johnson's ...
Posted by Michael Wonder on 15 Apr 2021
EMA starts review of VIR-7831 for treating patients with COVID-19
15 April 2021 - EMA is reviewing currently available data on the use of the monoclonal antibody VIR-7831 (also known as ...