PARP inhibitors seemed down for the count in 2011, after Sanofi’s iniparib failed in a phase III trial in triple- negative breast cancer and AstraZeneca’s olaparib suffered a setback in ovarian cancer. But as drug developers realized that iniparib was not a true PARP inhibitor, and adopted a more cautious clinical trial strategy, the class mounted a comeback. In the past 5 years the FDA has approved four PARP inhibitors, from AstraZeneca, Clovis, GlaxoSmithKline and Pfizer, most notably for ovarian and breast cancers in patients…
Centro de Inovação e Estudos Pré-clínicos oferece o II Curso sobre desenvolvimento de medicamentos com foco em estudo não clínico com apoio do Ministério da Saúde e do INCTINOVAMED.
O CIEnP ofereceu entre os dias 4 a 8 de Novembro de 2019, o II curso sobre ”Desenvolvimento de medicamentos com foco em estudos não clínicos”. O curso teve carga horária de 40 horas, foi financiado pelo Ministério da Saúde através da SCTIE/DECIT e contou com apoio do INCT-INOVAMED. Foram ao todo 60 participantes sendo 17 participantes do setor público, 19 do setor privado (Indústrias farmacêuticas e Start ups) e 24 da academia. Para a realização do curso o CIEnP convidou dois pesquisadores internacionais com…
FDA new drug approvals in Q3 2019
The biggest approval of the third quarter was not a new drug, but an oral version of Novo Nordisk’s semaglutide, branded Rybelsus, which has a consensus sales forecast of $3.3 billion in 2024. Rybelsus is entering a crowded field with over six other glucagonlike peptide 1 receptor agonists already approved, including Novo’s once- weekly injectable version of semaglutide, Ozempic… Para acessar a publicação na íntegra clique aqui Fonte:816 | NOVEMBER 2019 | volume 18 www.nature.com/nrd…
Gene therapy successes point to better therapies
The drug Zolgensma was recently in the news for all the wrong reasons. In August, the US Food and Drug Administration (FDA) gave drug manufacturer AveXis, Inc, a subsidiary of Novartis AG, a major slap on the wrist for violations related to the approval of Zolgensma, a new treatment for spinal muscular atrophy (SMA). The agency said the company had failed to promptly report to the proper regulatory authorities issues of datamanipulation in some product testing.Ominous newspaper headlines followed… Para acessar a publicação na íntegra clique aqui Fonte: 23866–23870 |…