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RSS FeedPosted by Michael Wonder on 29 Sep 2022
EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products
29 September 2022 - EMA is launching a pilot to support the translation of basic research developments into medicines that could ...
Posted by Michael Wonder on 29 Sep 2022
Europe's generic drugmakers say they may cut output due to energy bills
28 September 2022 - Europe's drugmakers have warned they may stop making some cheap generic medicines because of surging electricity ...
Posted by Michael Wonder on 29 Sep 2022
European Medicines Agency accepts Moderna's conditional marketing authorisation filing for its Omicron BA.4/BA.5 targeting bivalent COVID-19 vaccine
28 September 2022 - Filing follows approval of Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent booster vaccine targeting the Omicron BA.1 ...
Posted by Michael Wonder on 23 Sep 2022
Ultomiris approved in Europe for the treatment of adults with generalised myasthenia gravis
23 September 2022 - First and only long-acting C5 inhibitor has demonstrated early onset and sustained clinical benefit, and may reduce ...
Posted by Michael Wonder on 22 Sep 2022
BridgeBio Pharma and Sentynl Therapeutics receive marketing authorisation in the EU for Nulibry (fosdenopterin) for the treatment of MOCD type A
20 September 2022 - Nulibry was BridgeBio’s first FDA approved therapeutic; Sentynl acquired global rights to Nulibry in March 2022. ...
Posted by Michael Wonder on 21 Sep 2022
Alnylam receives approval in Europe for Amvuttra (vutrisiran) for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy
20 September 2022 - Amvuttra demonstrated halting or reversal in neuropathy impairment with subcutaneous administration once every three months. ...
Posted by Michael Wonder on 21 Sep 2022
EU health regulator says COVID pandemic not over
20 September 2022 - An official at the European Union's drugs regulator said on Tuesday the COVID-19 pandemic was not ...
Posted by Michael Wonder on 21 Sep 2022
Tezspire approved in the EU for the treatment of severe asthma
21 September 2022 - First and only biologic approved in the EU in patients with severe asthma with no phenotype ...
Posted by Michael Wonder on 20 Sep 2022
CHMP adopts positive opinion for Mycapssa for the treatment of acromegaly
16 September 2022 - Positive opinion based on MPOWERED Phase 3 trial. ...
Posted by Michael Wonder on 20 Sep 2022
EMA accepts MediWound’s application for extended indication for NexoBrid to treat paediatric patients with severe thermal burns
20 September 2022 - Upon approval, NexoBrid will serve as a safe and effective non-surgical treatment option in the EU for ...
Posted by Michael Wonder on 20 Sep 2022
Aurinia announces European Commission approval of Lupkynis (voclosporin) for the treatment of lupus nephritis
19 September 2022 - Lupkynis is the first oral medicine approved in both the US and Europe for the treatment of ...
Posted by Michael Wonder on 20 Sep 2022
Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19
20 September 2022 - Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase 3 treatment trial. ...
Posted by Michael Wonder on 20 Sep 2022
European Medicine Agency accepts marketing authorisation applications for bimekizumab in psoriatic arthritis and axial spondyloarthritis
20 September 2022 - First regulatory submissions for bimekizumab in psoriatic arthritis and axial spondyloarthritis worldwide. ...
Posted by Michael Wonder on 19 Sep 2022
European Commission approves Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
19 September 2022 - Phase 3 data that showed people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular oedema treated with ...
Posted by Michael Wonder on 19 Sep 2022
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with marginal zone lymphoma
19 September 2022 - If approved, Brukinsa will be the first and only approved Bruton’s tyrosine kinase inhibitor for marginal zone ...