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RSS FeedPosted 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. ...
Posted by Michael Wonder on 22 Feb 2021
EMA plots earlier engagement with patient groups
19 February 2021 - The EMA on Friday announced it will pilot an early engagement program to bring patient and ...
Posted by Michael Wonder on 21 Feb 2021
von der Leyen admits to COVID-19 vaccine failures
20 February 2021 - EU Commission President Ursula von der Leyen's comments come after much scrutiny of the EU vaccination ...
Posted by Michael Wonder on 20 Feb 2021
Dynavax announces European Commission marketing authorization for Heplisav B, a two dose adult hepatitis B adjuvanted vaccine
19 February 2021 - Approval based on safety and immunogenicity results from three Phase 3 clinical trials. ...
Posted by Michael Wonder on 20 Feb 2021
Confusion over Russia's EU vaccine approval bid could be result of misdirected application
20 February 2021 - Russia’s submission of its Sputnik V vaccine for approval by the European Union’s medicines regulator appears ...
Posted 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 ...