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RSS FeedPosted by Michael Wonder on 18 Jul 2022
AbbVie submits marketing authorisation application to EMA for atogepant for the preventive treatment of migraine
18 July 2022 - The submission is based on two pivotal Phase 3 studies evaluating atogepant in adult patients with episodic ...
Posted by Michael Wonder on 16 Jul 2022
Polpharma Biologics announces EMA acceptance of marketing authorisation application for proposed biosimilar natalizumab
14 July 2022 - Polpharma Biologics announced today that the EMA has accepted the first-ever marketing authorisation application for biosimilar natalizumab, ...
Posted by Michael Wonder on 12 Jul 2022
EMA launches pilot project on analysis of raw data from clinical trials
12 July 2022 - EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical ...
Posted by Michael Wonder on 12 Jul 2022
Hansa Biopharma announces first patient treated in the post-authorisation efficacy study of Idefirix (imlifidase) in highly sensitised kidney transplant patients
11 July 2022 - The study is an obligation under the conditional marketing authorisation for Idefirix granted by the EMA ...
Posted by Michael Wonder on 11 Jul 2022
ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines
11 July 2022 - The European Centre for Disease Prevention and Control and the EMA are recommending that second booster ...
Posted by Michael Wonder on 10 Jul 2022
Novavax Nuvaxovid COVID-19 vaccine conditionally authorised in the European Union for adolescents aged 12 through 17
5 July 2022 - Nuvaxovid COVID-19 vaccine is the first protein-based option for adolescents aged 12 through 17 in Europe. ...
Posted by Michael Wonder on 10 Jul 2022
Pfizer and BioNTech submit a variation to EMA for the vaccination of children 6 months to less than 5 years with Comirnaty
8 July 2022 - y 8, 2022 — Pfizer and BioNTech today announced that the companies have submitted a variation to ...
Posted by Michael Wonder on 07 Jul 2022
EMA finalises companion diagnostic guidance
7 July 2022 - The EMA) has finalised guidance on companion diagnostics, addressing procedural aspects to facilitate consultation between EMA ...
Posted by Michael Wonder on 04 Jul 2022
Global regulators agree on key principles on adapting vaccines to tackle virus variants
1 July 2022 - On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 ...
Posted by Michael Wonder on 29 Jun 2022
Bavarian Nordic announces grant of PRIME eligibility from the EMA for its RSV vaccine candidate for the prevention of respiratory syncytial virus in older adults
28 June 2022 - Bavarian Nordic announced today that the EMA has granted access to its priority medicines (PRIME) scheme for ...
Posted by Michael Wonder on 28 Jun 2022
Monkeypox: EMA starts review for Imvanex
28 June 2022 - The EMA’s CHMP has started a review of data to extend the use of the smallpox ...
Posted by Michael Wonder on 28 Jun 2022
Janssen receives positive CHMP opinion for Imbruvica (ibrutinib) in a fixed-duration combination regimen for adult patients with previously untreated chronic lymphocytic leukaemia
24 June 2022 - The positive opinion is based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated ...
Posted by Michael Wonder on 28 Jun 2022
Kyowa Kirin receives positive CHMP opinion for use of Crysvita (burosumab) for the treatment of tumour-induced osteomalacia
24 June 2022 - Crysvita could offer access to the first biologic treatment for EU patients with tumour-induced osteomalacia who cannot ...
Posted by Michael Wonder on 28 Jun 2022
Nexviadyme (avalglucosidase alfa) approved by European Commission as a potential new standard of care for the treatment of Pompe disease
28 June 2022 - Approved for the treatment of the full spectrum of both late-onset Pompe disease and infantile-onset Pompe disease. ...
Posted by Michael Wonder on 28 Jun 2022
Cosentyx (secukinumab) receives expanded approvals in EU for use in childhood arthritic conditions
27 June 2022 - Approvals based on data from the JUNIPERA trial, showing that Cosentyx® (secukinumab) reduced the risk of flare ...