Blog
RSS FeedPosted by Michael Wonder on 16 Feb 2021
Celltrion Healthcare receives European Commission approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, Yuflyma (CT-P17)
15 February 2021 - Yuflyma is approved in all intended indications for the treatment of multiple chronic inflammatory diseases. ...
Posted by Michael Wonder on 15 Feb 2021
Xeris Pharmaceuticals receives European Commission approval of Ogluo (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus
12 February 2021 - Ogluo Europe’s first and only ready-to-use liquid glucagon for rescue. ...
Posted by Michael Wonder on 14 Feb 2021
European Commission approves Seagen’s Tukysa (tucatinib) for the treatment of patients with locally advanced or metastatic HER2 positive breast cancer
12 February 2021 - Approved for adult patients with HER2 positive metastatic breast cancer who have received at least two prior ...
Posted by Michael Wonder on 10 Feb 2021
Drug maker will slash prices on cancer medicines to end price gouging probe in Europe
10 February 2021 - After months of deliberation, the European Commission has accepted an offer from Aspen Pharma to reduce ...
Posted 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 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
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 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 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 ...
Posted by Michael Wonder on 01 Feb 2021
Incyte announces positive CHMP opinion for pemigatinib for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or rearrangement
29 January 2021 - If approved, pemigatinib will be the first targeted therapy indicated in the EU for this indication. ...
Posted by Michael Wonder on 01 Feb 2021
EMA starts rolling review of REGN-COV2 antibody combination (casirivimab/imdevimab)
1 February 2021 - EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a medicine known ...