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PARP inhibitor pick- me-up

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 |…

Upcoming market catalysts in Q4 2019

Important catalysts expected to occur during the fourth quarter of 2019 include US approval decisions for brolucizumab in wet age- related macular degeneration (AMD) and for a long- acting cabotegravir  and rilpivirine combination, CARLA, to treat HIV-1 infection, as well as top- line results from a phase III study of SAGE-217 in major depressive disorder (MDD). Para acessar a publicação na íntegra clique aqui Fonte: 738 | OCTOBER 2019 | volume 18 BiObusinEss BRiEfs www.nature.com/nrd…

Claudin-9 structures reveal mechanism for toxin-induced gut barrier breakdown

The human pathogenic bacterium Clostridium perfringens secretes an enterotoxin (CpE) that targets claudins through its C-terminal receptor-binding domain (cCpE). Isoform-specific binding by CpE  causes dissociation of claudins and tight junctions (TJs), resulting in cytotoxicity and breakdown of the gut epithelial barrier. Here,  we present crystal structures of human claudin-9 (hCLDN-9) in complex with cCpE at 3.2 and 3.3 Para acessar a publicação na íntegra clique aqui Fonte:  www.pnas.org/cgi/doi/10.1073/pnas.1908929116…

Gene therapy’s next installment

At the end of May, Zolgensma was approved by the US Food and Drug Administration (FDA) as a gene therapy for children up to the age of two with spinal muscular atrophy (SMA). This was followed on June 3 by the European Commission’s marketing authorization for Zynteglo, a gene therapy against transfusiondependent β-thalassemia in patients 12 years or older. While patient groups hailed the news, the price of these products provoked sticker shock: Zolgensma costs $2.1 million; Para acessar a publicação na íntegra clique aqui Fonte: Nature Biotechnology…

FDA new drug approvals in Q2 2019

The most prominent approval in the second quarter of 2019 was Novartis’s pioneering gene therapy for spinal muscular atrophy (SMA), Zolgensma (onasemnogene abeparvovec), a rare neuromuscular disease with a typical life expectancy of less than 2 years if untreated. Para acessar a publicação na íntegra clique aqui Fonte:NATure Reviews | Drug DIScovery volume 18 | August 2019 | 575…

Pills give patients a shot inside the stomach

In 1922, a 14-year-old boy in Toronto, Canada, received the first injection of insulin to treat life-threatening diabetes. The same year, researchers began to test oral insulin formulations, hoping to relieve people with diabetes of daily shots. That effort failed, as have dozens of similar attempts. But realistic hope for oral insulin may finally be here. Para acessar a publicação na íntegra clique aqui Fonte: SCIENCE sciencemag.org 8 FEBRUARY 2019 • VOL 363 ISSUE 6427 571…

Boom: 2018’s biotech IPOs

Biggest, richest, strongest, frothiest, riskiest; no matter what superlatives you want to apply, the biotech initial public offering (IPO) boom of 2018 was record breaking. In early December, Moderna Therapeutics’ US$604 million IPO — the largest ever for a venture-backed US biotech company — propelled the total capital raised in biotech IPOs during the year past the $8 billion threshold for the first time in the history of the sector… Para acessar a publicação na íntegra clique aqui Fonte: NATURE REVIEWS | DRUG DISCOVERY VOLUME 18 | JANUARY 2019 |…