Blog
RSS FeedPosted by Michael Wonder on 19 May 2021
Roche launches mySugr Pump Control within the mySugr app to simplify insulin pump therapy via smartphone
19 May 2021 - mySugr now allows control of the Accu-Chek Insight insulin pump directly via smartphone, starting in Austria, bringing ...
Posted by Michael Wonder on 17 May 2021
More flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine
17 May 2021 - EMA’s CHMP has recommended a change to the approved storage conditions of Comirnaty, the COVID-19 vaccine ...
Posted by Michael Wonder on 17 May 2021
EMA publishes agenda for 17-20 May CHMP meeting
17 May 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 11 May 2021
Additional measures to allow experts to focus on COVID-19 activities
11 May 2021 - EMA is implementing additional temporary measures to further streamline activities in the European medicines regulatory network ...
Posted by Michael Wonder on 11 May 2021
US, EU regulators discuss tailoring biosimilar approvals
11 May 2021 - A tailored approach to biosimilar approvals is conceived as the next big leap for regulatory advancement in ...
Posted by Michael Wonder on 10 May 2021
Positive CHMP opinion for self-administered Crysvita
10 May 2021 - The EMA's CHMP has recommended Kyowa Kirin’s Crysvita for a new self-administration option to treat the ...
Posted by Michael Wonder on 07 May 2021
International regulators and WHO call for wider public access to clinical data
7 May 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation are urging pharmaceutical companies to ...
Posted by Michael Wonder on 07 May 2021
EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19
7 May 2021 - EMA’s CHMP has started a ‘rolling review’ of data on sotrovimab (also known as VIR-7831 and ...
Posted by Michael Wonder on 06 May 2021
European Commission approves Benlysta for adult patients with active lupus nephritis
5 May 2021 - First and only biologic approved for both systemic lupus erythematosus and lupus nephritis ...
Posted by Michael Wonder on 05 May 2021
Roche’s Tecentriq approved by European Commission as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer
5 May 2021 - This approval marks Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung ...
Posted by Michael Wonder on 04 May 2021
EMA starts rolling review of COVID-19 vaccine (Vero Cell) inactivated
4 May 2021 - EMA’s CHMP has started a rolling review of COVID-19 Vaccine (Vero Cell) inactivated, developed by Sinovac ...
Posted by Michael Wonder on 04 May 2021
Astellas' Xtandi (enzalutamide) approved by European Commission for men with metastatic hormone sensitive prostate cancer
4 May 2021 - Enzalutamide is now the only oral therapy approved by the European Commission to treat three distinct types ...
Posted by Michael Wonder on 03 May 2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15
3 May 2021 - EMA has started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to ...
Posted by Michael Wonder on 03 May 2021
BioCryst receives European Commission approval of Orladeyo (berotralstat), first oral, once daily therapy to prevent attacks in hereditary angioedema patients
30 April 2021 - BioCryst Pharmaceuticals today announced that the European Commission has approved oral, once daily Orladeyo (berotralstat) for ...
Posted by Michael Wonder on 01 May 2021
Legend Biotech announces submission of European marketing authorisation application for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma
30 April 2021 - Submission follows accelerated assessment granted by the Committee for Medicinal Products for Human Use of the European ...