Blog
RSS FeedPosted by Michael Wonder on 19 Dec 2022
Enhertu approved in the EU for patients with previously treated HER2 positive advanced gastric cancer
19 December 2022 - Based on DESTINY-Gastric02 and DESTINY-Gastric01 where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated clinically meaningful efficacy. ...
Posted by Michael Wonder on 19 Dec 2022
Imfinzi plus Imjudo recommended for approval in the EU by CHMP for the treatment of advanced liver and lung cancers
19 December 2022 - Positive opinions based on significant survival benefit in HIMALAYA and POSEIDON Phase 3 trials. ...
Posted by Michael Wonder on 19 Dec 2022
Fintepla (fenfluramine) oral solution recommended for approval in the EU for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome
19 December 2022 - Recommendation based on Phase 3 trial data demonstrating safety and efficacy in the most difficult to treat ...
Posted by Michael Wonder on 18 Dec 2022
Apellis submits marketing authorisation application to the EMA for pegcetacoplan for geographic atrophy
16 December 2022 - Apellis Pharmaceuticals today announced that the company has submitted a marketing authorisation application to the European Medicines ...
Posted by Michael Wonder on 18 Dec 2022
Amicus Therapeutics receives positive CHMP opinion for Pombiliti (cipaglucosidase alfa) for late-onset Pompe disease
16 December 2022 - CHMP adopts positive opinion based upon complete review of all pre-clinical, clinical studies and CMC data. ...
Posted by Michael Wonder on 18 Dec 2022
Finerenone receives positive CHMP opinion for EU label extension for broad range of patients with chronic kidney disease and type 2 diabetes
16 December 2022 - CHMP opinion is based on the results from the Phase 3 FIGARO-DKD cardiovascular outcomes trial in patients ...
Posted by Michael Wonder on 18 Dec 2022
CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A
16 December 2022 - The positive CHMP opinion is based on the results of the HAVEN 6 trial, which demonstrated effective ...
Posted by Michael Wonder on 16 Dec 2022
Dupixent (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic oesophagitis
16 December 2022 - If approved, Dupixent would be the first and only targeted medicine specifically indicated for people aged 12 ...
Posted by Michael Wonder on 16 Dec 2022
CSL receives positive CHMP opinion for etranacogene dezaparvovec – gene therapy for adults with haemophilia B
16 December 2022 - Regulatory milestone moves CSL one step closer to bringing the promise of gene therapy for haemophilia ...
Posted by Michael Wonder on 15 Dec 2022
Dupixent (dupilumab) approved by European Commission as the first and only targeted medicine indicated for prurigo nodularis
15 December 2022 - Approval based on direct to Phase 3 program showing more than three times as many Dupixent patients ...
Posted by Michael Wonder on 13 Dec 2022
EMA publishes agenda for the 12-15 December CHMP meeting
12 December 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 08 Dec 2022
Takeda’s Qdenga (dengue tetravalent vaccine [live, attenuated]) approved for use in European Union
8 December 2022 - Qdenga becomes the only dengue vaccine approved in the EU for use in individuals regardless of previous ...
Posted by Michael Wonder on 07 Dec 2022
ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination
6 December 2022 - EMA’s Emergency Task Force considers that adapted mRNA bivalent vaccines targeting the original strain and Omicron ...
Posted by Michael Wonder on 06 Dec 2022
Ionis announces European Medicines Agency accepts marketing authorisation application of tofersen to treat rare, genetic form of ALS
5 December 2022 - EMA acceptance follows FDA's acceptance of tofersen new drug application earlier this year. ...
Posted by Michael Wonder on 04 Dec 2022
EMA validates application for arpraziquantel to treat schistosomiasis in pre-school aged children
2 December 2022 - Merck, a leading science and technology company, and the Pediatric Praziquantel Consortium, today announced that the EMA ...