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RSS FeedPosted by Michael Wonder on 31 Mar 2021
Merck receives positive EU CHMP opinion for updated label of Keytruda (pembrolizumab) to include results of Phase 3 KEYNOTE-361 trial in certain adult patients with locally advanced or metastatic urothelial cancer
30 March 2021 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending that the ...
Posted by Michael Wonder on 31 Mar 2021
AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues
31 March 2021 - EMA’s safety committee (PRAC) is meeting today in the context of its ongoing review of very ...
Posted by Michael Wonder on 31 Mar 2021
Ontozry (cenobamate) receives European Commission approval for the treatment of drug resistant focal onset seizures in adults
30 March 2021 - SK Biopharmaceuticals and Angelini Pharma will collaborate to launch the treatment in countries in the European Economic ...
Posted by Michael Wonder on 31 Mar 2021
Novartis receives EU approval for Kesimpta (ofatumumab), the first and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis
30 March 2021 - Approval based on two Phase 3 ASCLEPIOS studies that met primary endpoints where Kesimpta showed a reduction ...
Posted by Michael Wonder on 31 Mar 2021
Evive Biotech submits biologics license application to US FDA for Ryzneuta
31 March 2021 - Evive is the first Chinese biologics company to advance a novel biologic product from pre-clinical studies to ...
Posted by Michael Wonder on 31 Mar 2021
Roche’s Evrysdi approved by European Commission as first and only at home treatment for spinal muscular atrophy
30 March 2021 - Roche is actively engaging with health authorities in the European Union to achieve broad and rapid access ...
Posted by Michael Wonder on 31 Mar 2021
Amarin receives European Commission approval for Vazkepa to reduce cardiovascular risk
30 March 2021 - Marks first and only European Commission approved treatment to reduce cardiovascular risk in high risk, statin treated ...
Posted by Michael Wonder on 31 Mar 2021
VFMCRP and Cara Therapeutics announce European Medicines Agency has accepted to review the marketing authorisation application for difelikefalin
30 March 2021 - Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics today announced that the EMA accepted to ...
Posted by Michael Wonder on 30 Mar 2021
EMA accepts the marketing authorisation applications for two additional indications of anti-cancer agent lenvatinib in combination with pembrolizumab as a treatment for advanced renal cell carcinoma and advanced endometrial carcinoma
30 March 2021 - Eisai announced today that the EMA has confirmed it has accepted for review applications for the use ...
Posted by Michael Wonder on 30 Mar 2021
Incyte announces the European Commission approval of Pemazyre (pemigatinib) as a treatment for adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or rearrangement
29 March 2021 - Pemazyre is the first targeted therapy approved in the European Union for this indication. ...
Posted by Michael Wonder on 30 Mar 2021
Karyopharm receives conditional marketing authorisation from the European Commission for Nexpovio (selinexor) in combination with dexamethasone for the treatment of adult patients with relapsed and or refractory multiple myeloma
29 March 2021 - Second European Regulatory Filing Based on Phase 3 BOSTON Data Expected by April 2021. ...
Posted by Michael Wonder on 30 Mar 2021
Myovant Sciences announces European Medicines Agency validation of marketing authorisation application for relugolix for the treatment of advanced prostate cancer
29 March 2021 - Pfizer has an exclusive option to commercialise relugolix in oncology outside of the U.S. and Canada, ...
Posted by Michael Wonder on 29 Mar 2021
Amryt announces validation of its MAA by the EMA for Oleogel-S10 (Filsuvez)
29 March 2021 - Amryt today announces the validation of the Company’s marketing authorisation application for Oleogel-S10 by the EMA for ...
Posted by Michael Wonder on 29 Mar 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for patients with muscle-invasive urothelial carcinoma
29 March 2021 - If approved, Opdivo would be the first adjuvant immunotherapy option for patients with muscle-invasive urothelial carcinoma in ...
Posted by Michael Wonder on 29 Mar 2021
Rocket Pharmaceuticals receives EMA Priority Medicines (PRIME) designation for RP-L201 gene therapy for treatment of leukocyte adhesion deficiency-I
29 March 2021 - LAD-I program now holds all available accelerated regulatory designations in the U.S. and EU. ...