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RSS FeedPosted by Michael Wonder on 18 Feb 2021
Pfizer and BioNTech to supply the European Union with 200 million additional doses of Cominarty
17 February 2021 - New agreement brings total supply to the European Union to 500 million doses, with delivery expected by ...
Posted by Michael Wonder on 16 Feb 2021
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
16 February 2021 - EMA has received an application for conditional marketing authorisation for a COVID-19 vaccine developed by Janssen-Cilag. ...
Posted 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 12 Feb 2021
EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
12 February 2021 - EMA’s human medicines committee (CHMP) has started a rolling review of CVnCoV, a COVID‑19 vaccine being ...
Posted by Michael Wonder on 10 Feb 2021
European Union admits errors in coronavirus vaccine rollout, 'deeply regrets' decision on export curbs
10 February 2021 - European Commission President Ursula von der Leyen has acknowledged failings in the EU's approval and rollout ...
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 10 Feb 2021
EMA expected to approve Johnson & Johnson vaccine by March
10 February 2021 - The European Medicines Agency is expected to give its approval to the COVID-19 vaccine developed by ...
Posted by Michael Wonder on 10 Feb 2021
Clarification on Sputnik V vaccine in the EU approval process
10 February 2021 - The EMA has to date not received an application for a rolling review or a marketing ...
Posted by Michael Wonder on 10 Feb 2021
EMA preparing guidance to tackle COVID-19 variants
10 February 2021 - EMA is developing guidance for manufacturers planning changes to the existing COVID-19 vaccines to tackle the new ...
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, ...