After years of trying, researchers have finally shown that a targeted anti-inflammatory agent can guard against life-threatening plaque ruptures in heart attack survivors who remain at risk of further vascular events despite well-controlled lipid levels… Fonte: Nature Reviews Drug Discovery | Published online 29 Sep 2017 Click here to original publication29…
Bispecific antibody pipeline moves beyond oncology
The FDA is currently reviewing Roche’s bispecific antibody emicizumab for the treatment of haemophilia A… Fonte: Nature Reviews Drug Discovery | Published online 29 Sep 2017 Click here to original publication…
FDA approves first CAR T therapy
The FDA gave the green light to Novartis’s tisagenlecleucel for the treatment of acute lymphoblastic leukaemia (ALL), marking a historic approval for a first-in-modality chimeric antigen receptor (CAR) T cell therapy… Fonte: Nature Reviews Drug Discovery | Published online 29 Sep 2017 Click here to original publication…
FDA OKs first in vitro route to expanded approval
In vitro data can be used to accelerate the approval of drugs that target specific disease-causing mutations for additional subpopulations of patients with rare diseases such as cystic fibrosis. Katie Kingwell In May, the FDA granted expanded approval to Vertex Pharmaceuticals’ cystic fibrosis (CF) drug ivacaftor on the basis of in vitro data. The change adds 23 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene to the existing 10 mutations previously covered by the drug label, representing a…
FDA approves first-in-class cancer metabolism drug
The FDA approved Agios’ and Celgene’s enasidenib for acute myeloid leukaemia (AML), validating metabolism-modulating drugs as a means of killing cancer cells. Enasidenib (formerly AG-221) is a first-in-class inhibitor of mutated isocitrate dehydro genase 2 (IDH2). The IDH enzymes normally metabolize isocitrate into α-ketoglutarate. When they are mutated in cancers, they also convert α-ketoglutarate into 2-hydroxyglutarate, an oncometabolite that causes cell differentiation defects by impairing histone demethylation. In clinical trials of enasidenib, 23% of treated patients had complete responses or complete…
Go-ahead for first anti-IL-23 mAb to treat psoriasis
On July 13, the US Food and Drug Administration (FDA) approved Tremfya (guselkumab) to treat moderate to severe plaque psoriasis. Tremfya, developed by Johnson & Johnson’s subsidiary Janssen, of Beers, Belgium, is the first and only human monoclonal antibody (mAb) that selectively blocks… Fonte: VOLUME 35 NUMBER 9 SEPTEMBER 2017 NATURE BIOTECHNOLOGY Click here to original publication…
CRISPR patent estate splinters
The long-running CRISPR–Cas9 patent dispute over rights to the lucrative gene-editing tool has taken a new turn with the European Patent Office announcing its intention to award Merck KGA… VOLUME 35 NUMBER 9 SEPTEMBER 2017 NATURE BIOTECHNOLOGY Click here to original publication…
FDA approves first-in-class cancer metabolism drug
The FDA approved Agios’ and Celgene’s enasidenib for acute myeloid leukaemia (AML), validating metabolism-modulating drugs as a means of killing cancer cells. Click here to original publication. Fonte: Nature Reviews Drug Discovery VOLUME 16 | SEPTEMBER 2017 | 593…