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 Para acessar a publicação na íntegra clique aqui…
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 Para acessar a publicação na íntegra clique aqui…
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 Para acessar a publicação na íntegra clique aqui…
CIEnP organiza evento em parceria com a Academia Brasileira de Ciências e EMBRAPII para discutir inovação tecnológica em Fármacos e Medicamentos.
O evento ocorreu no dia 26 de setembro passado e contou com a presença de mais de 60 pessoas, incluindo o presidente da Academia Brasileira de Ciências, Professor Luiz Davidovich, o Vice Presidente da ABC Professor João Fernandes G. de Oliveira , o Diretor Presidente da Embrapii Professor Jorge A. Guimarães, O secretario de Inovação do MCTIC, professor Álvaro Prata, o Diretor de Inovação da FINEP Victor Odorcyk, a diretora do Departamento de Ciência e Tecnologia – DECIT do Ministério…
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 Para acessar a publicação na íntegra clique aqui…
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 Para acessar a publicação na íntegra clique aqui…
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 further ~900 patients in the United States,…
FDA rejects first-in-class osteoporosis drug
Asher Mullard The FDA rejected Amgen’s and UCB’s romosozumab, an anti-sclerostin monoclonal antibody that the firms are developing for the treatment of osteoporosis. The rejection followed on the heels of a cardiovascular safety signal that the companies reported in May. Amgen and UCB are now working to resubmit the application and hope to incorporate new data from ongoing phase III trials to address regulatory questions and concerns. Nearly all of the osteoporosis drugs that have been approved to date act by lowering bone resorption processes, but in doing…