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RSS FeedPosted by Michael Wonder on 15 Oct 2022
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with CLL
14 October 2022 - If approved, Brukinsa would be the only BTK inhibitor for chronic lymphocytic leukaemia in the European Union to ...
Posted by Michael Wonder on 15 Oct 2022
Takeda receives positive CHMP opinion recommending approval of Dengue vaccine candidate in EU and Dengue endemic countries
14 October 2022 - TAK-003 recommended for the prevention of Dengue disease caused by any Dengue virus serotype in individuals four ...
Posted by Michael Wonder on 14 Oct 2022
Novartis receives positive CHMP opinion for Pluvicto for patients with progressive, PSMA positive metastatic castration-resistant prostate cancer
14 October 2022 - Phase 3 VISION trial showed Pluvicto plus best standard of care significantly improved survival for patients with ...
Posted by Michael Wonder on 14 Oct 2022
Libtayo (cemiplimab) receives positive CHMP opinion recommending approval to treat advanced cervical cancer
14 October 2022 - Recommendation based on a Phase 3 Libtayo trial that was first and only to demonstrate significantly ...
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
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
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 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 ...
Posted by Michael Wonder on 19 Sep 2022
Bristol Myers Squibb receives European Commission approval for LAG-3 blocking antibody combination, Opdualag (nivolumab and relatlimab), for the treatment of unresectable or metastatic melanoma with tumour cell PD-L1 expression < 1%
16 September 2022 - In RELATIVITY-047, Opdualag more than doubled median progression-free survival compared to nivolumab monotherapy. ...
Posted by Michael Wonder on 19 Sep 2022
AbbVie secures positive CHMP opinion for risankizumab (Skyrizi) for the treatment of adults with moderate to severe Crohn's disease
19 September 2022 - CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one ...
Posted by Michael Wonder on 18 Sep 2022
Agios receives positive CHMP opinion for Pyrukynd (mitapivat) for the treatment of pyruvate kinase deficiency in adult patients
16 September 2022 - Agios expects a decision on the marketing authorisation application by the European Commission within 67 days of ...