In a quarter that was marked by the rapid spread of the COVID-19 pandemic, drug approvals continued (Table 1), but launching was a completely different matter. Zeposia (ozanimod), the most eagerly awaited new drug of the quarter, is not going to reach patients with multiple sclerosis soon, after Bristol- Myers Squibb announced that it would be delaying its debut. Para acessar a publicação na íntegra clique aqui Fonte: Nature Reviews | Drug DIScovery NEWS & ANALYSIS volume 19 | May 2020 | 299…
IGF-1R drugs travel from cancer cradle to Graves’
One of the most intensively investigated molecular targets in oncology proves its therapeutic worth for thyroid eye disease. The first antibody drug targeting the insulin-like growth factor 1 receptor (IGF-1R) won regulatory approval in January — although not for the treatment of cancer, the indication first pursued more than a decade ago in some 30 different development programs involving experimental IGF-1R inhibitors. Instead, Horizon Therapeutics’ Tepezza (teprotumumab) became the first and only medicine approved by the US Food and Drug Administration for the treatment of thyroid eye disease (TED), a visionthreatening autoimmune disorder, also known…
O Centro de Inovação e Estudos Pré-clínicos (CIEnP) ofereceu curso de permeabilidade intestinal in vitro para alunos do MERCOSUL, através da Plataforma Regional de Métodos Alternativos ao Uso de Animais de experimentação (PReMASUL), vinculada ao MCTIC
O CIEnP ofereceu, entre os dias 09 e 13 de março de 2020, o curso sobre ”Avaliação da permeabilidade intestinal in vitro através das células Caco-2”, com carga horária de 40 horas e financiado pelo MCTIC, via CNPq. O curso teve como objetivo principal promover a capacitação e treinamento de recursos humanos, para que os mesmos estejam aptos a implementar em seus laboratórios e países a metodologia abordada durante a semana. Ao todo foram 9 participantes dos países do MERCOSUL, entre estudantes de pós-graduação, profissionais e…
VISITA AO CIEnP – Dr. Jack L. Arbiser
Dr Jack L. Arbiser, M.D.,Ph.D., Professor do Department of Dermatology, Winship Cancer Institute Atlanta Veterans Administration, Emory University, Atlanta, USA visitou o CIEnP no dia 26 de fevereiro de 2020. Na ocasião o professor Jack proferiu uma palestra aos pesquisadores do CIEnP sobre “ The Reactive Oxygen Driven Tumor: Implications for Therapy”. Além de pesquisador, o Dr Jack atua na área de inovação tecnológica e possui duas empresas (start up) que estão trabalhando na área de desenvolvimento de novas terapias para o tratamento do câncer. Foi…
VISITA AO CIEnP
No dia 4 de março de 2020 o Dr. Edson Antônio Bernes Júnior, Diretor de Pesquisa e Desenvolvimento da empresa Eurofarma visitou o CiEnP acompanhado de Carlos Eduardo Carelli Júnior (Desenvolvimento analítico) e Carlos Eduardo Matos (consultor da empresa Altox). Durante a visita foram discutidos vários projetos de parceria que a Eurofarma pretende realizar com o CIEnP na área de toxicologia não clínica para avaliar a segurança de impurezas.…
Anti-CD3 drug keeps diabetes at bay
The first drug to ever slow the progression from pre-diabetes to clinical type 1 diabetes is one step closer to reaching the market. On August 5, the US Food and Drug Administration (FDA) granted breakthrough therapy designation to teplizumab, a CD3-targeted antibody from Provention Bio, to prevent or delay type 1 diabetes onset among children and adults at high risk of developing the disease… Para acessar a publicação na íntegra clique aqui Fonte: Nature Biotechnology | VOL 37 | OCTOBER 2019 | 1099–1109 | www.nature.com/naturebiotechnology …
2019 FDA drug approvals
The FDA’s Center for Drug Evaluation and Research (CDER) approved 48 novel drugs in 2019 (Table 1). Although this approval count falls short of CDER’s record 59 approvals of 2018, it still comes in as the third biggest approval class in the past 25 years (Fig. 1). CDER’s 5-year rolling approval average now stands at 44 new drugs per year, double the nadir of 22 in 2009… Para acessar a publicação na íntegra clique aqui Fonte: 80 | February 2020 | volume 19 www.nature.com/nrd…
New Drug Therapy Approvals 2019
Advancing Health Through Innovation: New Drug Therapy Approvals 2019 IMPACT INNOVATION PREDICTABILITY ACCESS FDA’s Center for Drug Evaluation and Research January 2020 Para acessar a publicação na íntegra clique aqui Fonte: FDA’s Center for Drug Evaluation and Research…
Drug pipeline 3Q19
The third quarter saw US Food and Drug Administration approvals for two anti-infectives. Pretomanid, indicated for drug-resistant tuberculosis (TB), is only the third TB drug approved over the past 50 years and the first antibiotic to be developed by a non-profit, the TB Alliance. Elsewhere, MSD Merck got the green light for Recarbrio, which is approved for intra-abdominal and for urinary and reproductive tract infections. Two new cancer drugs were approved through the agency’s accelerated approval pathway: Karyopharm’s Xpovio and Roche/Genentech’s Rozlytrek. In…
Drug pipeline 3Q19
The third quarter saw US Food and Drug Administration approvals for two anti-infectives. Pretomanid, indicated for drug-resistant tuberculosis (TB), is only the third TB drug approved over the past 50 years and the first antibiotic to be developed by a non-profit, the TB Alliance. Elsewhere, MSD Merck got the green light for Recarbrio, which is approved for intra-abdominal and for urinary and reproductive tract infections. Two new cancer drugs were approved through the agency’s accelerated approval pathway: Karyopharm’s Xpovio and Roche/Genentech’s Rozlytrek. In…