Blog
RSS FeedPosted by Michael Wonder on 04 Apr 2023
New features further strengthen Priority Medicines scheme (PRIME)
4 April 2023 - The EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to ...
Posted by Michael Wonder on 03 Apr 2023
Sandoz receives approval by European Commission for Hyrimoz (adalimumab) high-concentration formulation
3 April 2023 - Biosimilar Hyrimoz (adalimumab) citrate free high concentration formulation is now approved in the EU for use in ...
Posted by Michael Wonder on 03 Apr 2023
Ultomiris recommended for approval in the EU by CHMP for the treatment of adults with neuromyelitis optica spectrum disorder
3 April 2023 - No relapses observed in pivotal trial of first and only long-acting C5 inhibitor, indicating potential to ...
Posted by Michael Wonder on 02 Apr 2023
Samsung Bioepis receives positive CHMP opinion for eculizumab biosimilar, Epysqli
31 March 2023 - Epysqli, a biosimilar referencing Soliris (eculizumab), is Samsung Bioepis’ first biosimilar in haematology to be recommended for ...
Posted by Michael Wonder on 02 Apr 2023
TG Therapeutics announces positive CHMP opinion for Briumvi (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis in adults
31 March 2023 - TG Therapeutics today announced that the CHMP of the EMA has issued a positive opinion recommending ...
Posted by Michael Wonder on 02 Apr 2023
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory large B-cell lymphoma after one prior therapy
31 March 2023 - Recommendation for approval based on Phase 3 TRANSFORM study, supporting the potential of Breyanzi in earlier ...
Posted by Michael Wonder on 02 Apr 2023
Novartis Entresto receives positive CHMP opinion for a heart failure
31 March 2023 - The positive opinion is based on final data from the 52 week Phase 3 PANORAMA-HF trial, the ...
Posted by Michael Wonder on 01 Apr 2023
Highlights from the 27 - 30 March 2023 CHMP meeting
31 March 2023 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its March 2023 meeting. ...
Posted by Michael Wonder on 30 Mar 2023
EMA recommends approval of Bimervax as a COVID-19 booster vaccine
30 March 2023 - The EMA’s CHMP has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a ...
Posted by Michael Wonder on 29 Mar 2023
Libtayo (cemiplimab) in combination with chemotherapy approved by European Commission for the first-line treatment of advanced PD-L1 positive non-small-cell lung cancer
29 March 2023 - Approval marks second first-line indication in non-small-cell lung cancer and fifth indication for Libtayo in the ...
Posted by Michael Wonder on 28 Mar 2023
DARWIN EU has completed its first studies and is calling for new data partners
28 March 2023 - DARWIN EU, the Data Analysis and Real World Interrogation Network, has accomplished its first year of establishment. ...
Posted by Michael Wonder on 28 Mar 2023
Amicus Therapeutics announces European Commission approval for Pombiliti in patients with late-onset Pompe disease
27 March 2023 - CHMP opinion for miglustat, the oral enzyme stabiliser component of AT-GAA, on track for 2Q, 2023. ...
Posted by Michael Wonder on 27 Mar 2023
EMA validates marketing authorisation application for Henlius' Hansizhuang (serplulimab)
23 March 2023 - Hansizhuang (serplulimab) is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer. ...
Posted by Michael Wonder on 22 Mar 2023
Advancing regulatory science in the EU – mid-point report published
22 March 2023 - The EMA has published a report summarising the mid-term achievements of its regulatory science strategy to ...
Posted by Michael Wonder on 22 Mar 2023
Dupixent (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis
21 March 2023 - Milestone marks third Dupixent European Commission approval in the past four months. ...