BioCentury | Jul 24, 2020
Regulation

Data Bytes: CHMP’s July recommendations

...June (see “U.K. Approves Steroid” ). Danielle Golovin, Staff Writer Elzonris (tagraxofusp-erzs, SL-401) Gamifant, emapalumab-lzsg (NI-0501) Adakveo, crizanlizumab (SEG101, selg1) Arikayce...
BioCentury | Jan 24, 2020
Company News

ICER finds first wave of new sickle cell drugs improves outcomes, but not cost-effective

...price cuts to hit the $150,000 per quality-adjusted life year threshold. The group analyzed Adakveo crizanlizumab-tmca...
BioCentury | Jan 1, 2020
Company News

Fewer FDA approvals in 2019, but a basket of firsts

...Execs Impeded Investigation” ). Novartis had several other pharmaceutical firsts in 2019. FDA approved Adakveo crizanlizumab-tmca...
...ASG-22CE, ASG-22ME, asg-22m6e) trastuzumab deruxtecan (DS-8201, DS-8201a) VYONDYS 53, golodirsen (SRP-4053) Zolgensma, onasemnogene abeparvovec-xioi, ScAAV9.CB.SMN (AVXS-101, charisma) crizanlizumab (SEG101, selg1) Piqray...
BioCentury | Dec 13, 2019
Politics, Policy & Law

Novartis’ Narasimhan calls for value-based pricing--and access

...over as CEO include gene therapy Zolgensma onasemnogene abeparvovec-xioi for spinal muscular atrophy (SMA), Adakveo crizanlizumab...
BioCentury | Nov 26, 2019
Company News

Nov. 25 Company Quick Takes: FDA approves GBT's sickle cell therapy; plus ChemoCentryx, Astellas, La Jolla, Sorrento, Aquestive

...in hemoglobin levels, will have a wholesale acquisition cost (WAC) of $10,417 per month. Adakveo crizanlizumab-tmca...
BioCentury | Nov 19, 2019
Clinical News

Vertex, CRISPR show early benefits with therapy, but longer term data are needed to show how it stacks up

...FDA for Zynteglo this year. In sickle cell disease, FDA approved anti-P selectin antibody Adakveo crizanlizumab-tmca...
BioCentury | Nov 16, 2019
Company News

Approval of first targeted sickle cell therapy heralds arrival of new agents

...Scoring approval about two months ahead of its PDUFA date, Adakveo crizanlizumab-tmca from Novartis AG (NYSE:NVS...
...and has Orphan Drug status. Elizabeth S. Eaton, Staff Writer crizanlizumab (SEG101, selg1) Novartis AG P selectin (SELP) (CD62P) Adakveo crizanlizumab-tmca VCOs...
BioCentury | Nov 11, 2019
Product Development

Sickle cell disease poised for fresh infusion of hemoglobin-based endpoints

...which it will evaluate based on different primary endpoints. Approval of the anti-P selectin antibody crizanlizumab...
...Blood's clinical endpoints for SCD are directly tied to their products' mechanisms of action. Novartis' crizanlizumab...
...its clinical relevance, validation by FDA and other health authorities, and link to crizanlizumab's MOA. "'Crizanlizumab...
BioCentury | Nov 9, 2019
Product Development

Sickle cell disease poised for fresh infusion of hemoglobin-based endpoints

...which it will evaluate based on different primary endpoints. Approval of the anti-P selectin antibody crizanlizumab...
...Blood's clinical endpoints for SCD are directly tied to their products' mechanisms of action. Novartis' crizanlizumab...
...its clinical relevance, validation by FDA and other health authorities, and link to crizanlizumab's MOA. "'Crizanlizumab...
BioCentury | Aug 6, 2019
Clinical News

Next up for GlycoMimetics after tanking in sickle cell disease

...other possible indications. Rivipansel has not fared as well in the clinic as selectin inhibitor crizanlizumab...
...submission was based on the results of the Phase II SUSTAIN study, which showed that crizanlizumab...
...of VOCs leading to healthcare visits by 45.3% compared with placebo (1.63 vs. 2.98, p=0.010). Crizanlizumab...
Items per page:
1 - 10 of 31