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RSS FeedPosted 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 ...
Posted by Michael Wonder on 19 Nov 2022
European Commission approves Enjaymo (sutimlimab) for treatment of haemolytic anaemia in adult patients with cold agglutinin disease
17 November 2022 - Enjaymo is the first and only approved therapeutic option approved for haemolytic anaemia in adult patients ...
Posted by Michael Wonder on 15 Nov 2022
Lynparza in combination with abiraterone recommended for approval in the EU by CHMP as first-line treatment for patients with metastatic castration-resistant prostate cancer
14 November 2022 - First PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent in this ...
Posted by Michael Wonder on 15 Nov 2022
Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2 positive advanced gastric cancer
14 November 2022 - Based on DESTINY-Gastric02, which showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated clinically meaningful efficacy and DESTINY-Gastric01, which ...
Posted by Michael Wonder on 15 Nov 2022
Imfinzi plus chemotherapy recommended for approval in the EU by CHMP as first immunotherapy regimen for advanced biliary tract cancer
14 November 2022 - Positive opinion based on TOPAZ-1 Phase 3 trial updated survival results showing Imfinzi combination reduced risk ...
Posted by Michael Wonder on 12 Nov 2022
European Commission approves Livtencity (maribavir) for the treatment of adults with post-transplant cytomegalovirus infection and/or disease that are refractory (with or without resistance) to one or more prior therapies
11 November 2022 - Livtencity is the first and only treatment approved for this indication by the EC. ...
Posted by Michael Wonder on 11 Nov 2022
Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine booster for children 5 through 11 years of age in European Union
10 November 2022 - Pfizer and BioNTech today announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Comirnaty Original/Omicron ...
Posted by Michael Wonder on 11 Nov 2022
Meeting highlights from the 7-10 November 2022 CHMP meeting
11 November 2022 - The EMA’s CHMP recommended four medicines for approval at its November 2022 meeting. ...