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RSS FeedPosted by Michael Wonder on 27 May 2020
Prospective dialogue between developers and regulators makes for better evidence generation
27 May 2020 - EMA, in collaboration with other parties, has recently published two scientific articles outlining the importance of ...
Posted by Michael Wonder on 27 May 2020
Bristol Myers Squibb receives European Commission approval for Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease
27 May 2020 - Zeposia is the only approved sphingosine-1-phosphate receptor modulator for RRMS patients with active disease. ...
Posted by Michael Wonder on 27 May 2020
EMA publishes agenda for 25-28 May 2020 CHMP meeting
27 May 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 27 May 2020
EMA commissions independent research to prepare for real world monitoring of COVID-19 vaccines
27 May 2020 - EMA is engaging early with researchers to ensure that a European infrastructure will be in place to ...
Posted by Michael Wonder on 26 May 2020
EMA calls for high-quality observational research in context of COVID-19
26 May 2020 - For observational studies of real world data in COVID-19, EMA calls for transparency for protocols and results, ...
Posted by Michael Wonder on 24 May 2020
Fresenius Kabi’s regulatory submission for pegfilgrastim biosimilar accepted for review by EMA
22 May 2020 - Fresenius Kabi announced today that the EMA has accepted for review the company’s marketing authorisation application for ...
Posted by Michael Wonder on 23 May 2020
Intercept provides regulatory update
22 May 2020 - Intercept Pharmaceuticals today announced that based on discussions earlier this week, the U.S. FDA has notified Intercept ...
Posted by Michael Wonder on 22 May 2020
EMA validates Bristol Myers Squibb’s applications for idecabtagene vicleucel and CC-486
22 May 2020 - Applications based on positive results from pivotal KarMMa study in relapsed and refractory multiple myeloma and QUAZAR-AML-001 ...
Posted by Michael Wonder on 22 May 2020
European Medicines Agency accepts Astellas’ marketing authorisation application for roxadustat
21 May 2020 - Submission for the treatment of anaemia in adult patients with chronic kidney disease. ...
Posted by Michael Wonder on 21 May 2020
Incyte and MorphoSys announce the validation of the European marketing authorisation application for tafasitamab
20 May 2020 - The application seeks approval of tafasitamab in combination with lenalidomide for the treatment of adult patients with ...
Posted by Michael Wonder on 21 May 2020
EMA extends virtual-only meeting policy through August
20 May 2020 - The EMA has announced it is extending its decision to hold all upcoming meetings virtually through ...
Posted by Michael Wonder on 20 May 2020
Global regulators commit to cooperate on observational research in the context of COVID-19
20 May 2020 - Regulators from around the world have agreed three priority areas for cooperation on observational research during ...
Posted by Michael Wonder on 20 May 2020
Europe falls behind U.S. in funding coronavirus vaccine and securing access
19 May 2020 - U.S. was faster in shouldering drug companies’ costs to develop and manufacture vaccine candidates, putting the bloc ...
Posted by Michael Wonder on 19 May 2020
Top pharma official rejects idea of free COVID-19 vaccine for all
18 May 2020 - A leading representative of the pharmaceutical industry has downplayed the idea of a vaccine against the ...
Posted by Michael Wonder on 19 May 2020
AveXis receives EC approval and activates “Day One” access program for Zolgensma, the only gene therapy for spinal muscular atrophy
19 May 2020 - Zolgensma (onasemnogene abeparvovec) is conditionally approved in Europe for the treatment of patients with spinal muscular atrophy ...