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RSS FeedPosted by Michael Wonder on 09 Feb 2021
Spravato (esketamine nasal spray) authorised in Europe for the rapid reduction of depressive symptoms in a psychiatric emergency for patients with major depressive disorder
8 February 2021 - This milestone makes esketamine nasal spray the first N-methyl-D-aspartate antagonist to be approved for patients with major ...
Posted by Michael Wonder on 09 Feb 2021
Bristol Myers Squibb receives European Commission approval for Inrebic (fedratinib) for adult patients with newly diagnosed and previously treated myelofibrosis
8 February 2021 - Inrebic, a once-daily, oral therapy, is the first new treatment option approved in Europe for myelofibrosis in ...
Posted by Michael Wonder on 09 Feb 2021
ViiV Healthcare receives marketing authorisation for Rukobia (fostemsavir), a first-in-class attachment inhibitor in combination with other antiretrovirals for the treatment of adults with multidrug-resistant HIV
8 February 2021 - Fostemsavir addresses a critical need in HIV care for those with little to no treatment options left ...
Posted by Michael Wonder on 08 Feb 2021
International regulators working together to enhance collaboration on COVID-19 observational research
8 February 2021 - In a dedicated COVID-19 workshop, convened under the umbrella of the International Coalition of Medicines Regulatory Authorities, ...
Posted by Michael Wonder on 07 Feb 2021
Novavax announces start of rolling review by multiple regulatory authorities for COVID-19 vaccine authorisation
4 February 2021 - Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada. ...
Posted by Michael Wonder on 04 Feb 2021
EMA reviewing data on monoclonal antibody use for COVID-19
4 February 2021 - EMA’s CHMP is reviewing available data on the use of the monoclonal antibodies casirivimab, imdevimab, bamlanivimab and ...
Posted by Michael Wonder on 04 Feb 2021
EMA COVID-19 assessments ‘OPEN’ to non-EU regulators
4 February 2021 - EMA is piloting a new ‘OPEN’ initiative to increase international collaboration on the evaluation of COVID-19 vaccines ...
Posted by Michael Wonder on 04 Feb 2021
Aruvant announces the EMA granted PRIME designation to ARU-1801 for the treatment of sickle cell disease
3 February 2021 - Aruvant Sciences today announced that the EMA granted PRIME designation to ARU-1801, a one-time investigational gene therapy ...
Posted by Michael Wonder on 04 Feb 2021
EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373)
3 February 2021 - EMA’s CHMP has started a rolling review of NVX-CoV2373, a COVID‑19 vaccine being developed by Novavax. ...
Posted by Michael Wonder on 03 Feb 2021
New toolbox available for EMA's PRIME designees
2 February 2021 - The European Medicines Agency has released a draft guidance to assist drug developers using its Priority ...
Posted by Michael Wonder on 02 Feb 2021
Novo Nordisk receives positive opinion from the European regulatory authorities for once-weekly Sogroya (somapacitan) for the treatment of adult growth hormone deficiency
29 January 2021 - Novo Nordisk announced today that the CHMP, under the EMA, adopted a positive opinion for the use ...
Posted by Michael Wonder on 02 Feb 2021
Janssen announces CAR-T therapy ciltacabtagene autoleucel (cilta-cel) accepted for accelerated assessment in Europe for the treatment of patients with heavily pretreated multiple myeloma
1 February 2021 - Janssen announced today that the CHMP of the EMA will perform an accelerated assessment of the ...
Posted by Michael Wonder on 02 Feb 2021
Chiesi Group receives the European Marketing authorization for the extrafine triple-combination therapy for the treatment of moderate to severe asthma
1 February 2021 - It is the first extrafine fixed triple combination therapy in a single inhaler to be approved for ...
Posted by Michael Wonder on 01 Feb 2021
EU nations have received 18.5 million COVID-19 vaccines
2 February 2021 - Seeking to rebound from heavy criticism of its slow coronavirus vaccine rollout, the European Union said ...
Posted by Michael Wonder on 01 Feb 2021
Merck receives positive EU CHMP opinion for expanded approval of Keytruda (pembrolizumab) in certain patients with relapsed or refractory classical Hodgkin lymphoma
1 February 2021 - Opinion granted based on significant progression-free survival benefit demonstrated with Keytruda monotherapy compared to brentuximab vedotin in ...