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RSS FeedPosted by Michael Wonder on 19 Dec 2022
Forxiga recommended for approval in the EU by CHMP for symptomatic chronic heart failure
19 December 2022 - f approved, Forxiga will be the first heart failure therapy indicated across the full ejection fraction ...
Posted by Michael Wonder on 19 Dec 2022
Enhertu recommended for approval in the EU by CHMP for patients with HER2 low metastatic breast cancer
19 December 2022 - AstraZeneca and Daiichi Sankyo’s Enhertu is the first HER2 directed therapy to demonstrate a significant survival ...
Posted 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
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
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 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 30 Nov 2022
European Commission grants expanded marketing authorisation for Gilead’s Biktarvy for the treatment of HIV in paediatric populations
29 November 2022 - European Commission authorises a low dose tablet for HIV treatment in virologically suppressed children at least two ...
Posted by Michael Wonder on 29 Nov 2022
Capstone announces authorisation of biosimilar human insulin for IV infusion in Canada and EU
29 November 2022 - Capstone announced today that a biosimilar version of human insulin received authorisation from the EMA's CHMP ...
Posted by Michael Wonder on 23 Nov 2022
AbbVie announces European Commission approval of Skyrizi (risankizumab) for the treatment of moderate to severe active Crohn's disease
23 November 2022 - Third approved indication for Skyrizi (risankizumab) and the first specific IL-23 inhibitor for the treatment of Crohn's ...
Posted by Michael Wonder on 22 Nov 2022
Libtayo (cemiplimab) approved by the European Commission as the first immunotherapy in second-line recurrent or metastatic cervical cancer irrespective of PD-L1 expression level or tumour histology
22 November 2022 - Approval based on a Phase 3 trial that demonstrated significant survival benefit in patients with recurrent or ...
Posted by Michael Wonder on 19 Nov 2022
BeiGene receives European Commission approval for Brukinsa (zanubrutinib) for the treatment of adults with chronic lymphocytic leukaemia
17 November 2022 - Brukinsa is the only Bruton’s tyrosine kinase inhibitor to achieve superiority over ibrutinib in relapsed/refractory chronic lymphocytic ...