Blog
RSS FeedPosted by Michael Wonder on 05 Mar 2021
Idorsia submits European marketing authorisation application for daridorexant for the treatment of adult patients with insomnia
3 March 2021 - The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant ...
Posted by Michael Wonder on 04 Mar 2021
Blueprint Medicines announces EMA validation of type II variation marketing authorisation application for Ayvakyt (avapritinib) for the treatment of advanced systemic mastocytosis
3 March 2021 - Blueprint Medicines today announced that the EMA has validated the company's type II variation marketing authorisation application ...
Posted by Michael Wonder on 04 Mar 2021
EMA starts rolling review of the Sputnik V COVID-19 vaccine
4 March 2021 - EMA’s CHMP has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s ...
Posted by Michael Wonder on 02 Mar 2021
EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine
2 March 2021 - Openness and transparency are key to building confidence in COVID-19 vaccines. Today, EMA and Health Canada ...
Posted by Michael Wonder on 01 Mar 2021
LFB announces that the EMA has accepted for filing the marketing authorisation application for eptacog beta (activated), a recombinant coagulation factor VIIa
1 March 2021 - In addition, LFB announces the online publication of the exploratory in vitro study results on eptacog beta ...
Posted by Michael Wonder on 01 Mar 2021
Incyte announces the validation by the European Medicines Agency of its marketing authorisation application for retifanlimab as a treatment for patients with squamous cell anal carcinoma
26 February 2021 - Incyte today announced the validation of the Company’s marketing authorisation application for retifanlimab, an intravenous PD-1 ...
Posted by Michael Wonder on 01 Mar 2021
EMA accepts Pfizer's marketing authorisation application for its investigational 20 valent pneumococcal conjugate vaccine for adults 18 years of age or older
26 February 2021 - If approved, the vaccine would help protect adults against 20 serotypes responsible for the majority of invasive ...
Posted by Michael Wonder on 28 Feb 2021
EMA accepts marketing application for somatrogon to treat paediatric patients with growth hormone deficiency
26 February 2021 - If approved, somatrogon will serve as a once-weekly treatment option. ...
Posted by Michael Wonder on 28 Feb 2021
GSK receives CHMP positive opinion recommending approval of dostarlimab for women with recurrent or advanced endometrial cancer
26 February 2021 - GlaxoSmithKline today announced the CHMP of the EMA has adopted a positive opinion recommending dostarlimab, an anti-programmed ...
Posted by Michael Wonder on 26 Feb 2021
Roche receives positive CHMP opinion for Evrysdi, the first and only at home spinal muscular atrophy treatment with proven efficacy in adults, children and infants two months and older
26 February 2021 - Evrysdi is approved in seven countries, submitted in 30 more. ...
Posted by Michael Wonder on 26 Feb 2021
BioCryst receives positive CHMP opinion for Orladeyo (berotralstat), an oral, once daily therapy to prevent attacks in patients with hereditary angioedema
25 February 2021 - BioCryst Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion recommending ...
Posted by Michael Wonder on 25 Feb 2021
Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
25 February 2021 - EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in ...
Posted by Michael Wonder on 25 Feb 2021
International cooperation to align approaches for regulation of COVID-19 vaccines and medicines
25 February 2021 - Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate ...
Posted by Michael Wonder on 24 Feb 2021
EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19
24 February 2021 - EMA’s CHMP has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (also known ...
Posted by Michael Wonder on 22 Feb 2021
EMA publishes agenda for 22-25 February CHMP meeting
22 February 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...