The FDA granted accelerated approval to Loxo Oncology and Bayer’s larotrectinib for patients with solid tumours that have neurotrophic receptor tyrosine kinase (NTRK) gene fusions. Larotrectinib is the first drug to be developed entirely for a tissue-agnostic cancer indication that doesn’t depend on where the cancer originated… Para acessar a publicação na íntegra clique aqui Fonte: NATURE REVIEWS | DRUG DISCOVERY VOLUME 18 | JANUARY 2019 | 7…
Drug pipeline 3Q18
The third quarter saw a raft of first-in-class approvals, including the first RNA interference (RNAi) drug, the first nanobody, and a novel immunotoxin combining a CD22 Fv antibody fragment and an exotoxin. RNAi, antisense and small molecules achieved clinical… Fonte: VOLUME 36 NUMBER 12 DECEMBER 2018 NATURE BIOTECHNOLOGY Para acessar a publicação na íntegra clique aqui…
Biopharmaceutical benchmarks 2018
Antibodies continue to dominate biopharmaceutical approvals, but new nucleic acid modalities and cellular therapies are also slowly launching on the market. This article provides an update on three previous surveys of biopharmaceutical approvals1–3. Fonte: VOLUME 36 NUMBER 12 DECEMBER 2018 NATURE BIOTECHNOLOGY Para acessar a publicação na íntegra clique aqui …
First preventive mAb for hereditary angioedema
The US Food and Drug Administration has approved the first monoclonal antibody (mAb) to prevent hereditary angioedema (HEA) attacks. Dublin-based Shire was given the go-ahead in August to market Takhzyro (lanadelumab) as prophylactic treatment for HEA types I and II in patients aged 12 years or older. HEA is a rare but life-threatening genetic disease caused by mutations in the C1 esterase inhibitor gene, which leads to an overactivation of the complement system. This can trigger unpredictable bouts of subcutaneous or submucosal swelling anywhere in the body, potentially leading to blocked airways, and in…
FDA new drug approvals in Q3 2018
With one full quarter still to go before the end of the year, 41 novel drugs have already been approved by the FDA, putting 2018 on track to surpass 1996’s record 53 new drug approvals. Many of the 21 products approved in Q3 Fonte: NATURE REVIEWS | DRUG DISCOVERY VOLUME 17 | NOVEMBER 2018 | 779 Click here to original publication.…
How much do phase III trials cost?
Drug development has been estimated to cost anywhere from US$43 million on one controversial end of the spectrum to $2.9 billion on the other when failures, post-approval studies and opportunity cost are factored in… Fonte: NATURE REVIEWS | DRUG DISCOVERY VOLUME 17 | NOVEMBER 2018 | 777 Para acessar a publicação na íntegra clique aqui …
FDA approves first single-dose antimalarial
On July 20, the US Food and Drug Administration approved GlaxoSmithKline’s Krintafel (tafenoquine), a single-dose treatment to prevent relapses of Plasmodium vivax, a malaria parasite that causes more than eight million infections annually. “This drug could be transformative,” says David Reddy, executive director of Medicines for Malaria Venture, GlaxoSmithKline’s partner in the development of Krintafel. On August 9, the FDA also gave the go-ahead to 60 Degrees Pharmaceuticals for a six-month dosing regimen of tafenoquine tablets, commercialized as Arakoda, to prevent malaria in adults, including travelers and residents of disease-endemic countries… Para acessar…
PESQUISADORES DO CIEnP MINISTRAM CURSO SOBRE DESENVOLVIMENTO DE MEDICAMENTOS.
Na semana entre os dias 20 a 24 de agosto de 2018, os pesquisadores do Centro de Inovação de Ensaios Pré-clínicos (CIEnP) ministraram curso sobre ´DRUG DEVELOPMENT WITH FOCUS ON NON-CLINICAL STUDIES’. O curso foi financiado pelo DECIT/MS e foi apoiado pelo projeto INCT-INOVAMED que é coordenado pelo diretor do CIEnP. Também participaram do curso os pesquisadores Europeus que trabalharam por mais de 20 anos nas maiores empresas farmacêuticas mundiais: Dr. John Foster, PhD (Pesquisador Patologista da ToxPath Sciences Ltd,…
US approves first RNA interference drug
The first therapy based on RNA interference (RNAi) gene silencing has been approved by the US Food and Drug Administration (FDA). Alnylam Pharmaceuticals got the green light for Onpattro (patisiran), to treat hereditary transthyretin amyloidosis – a rare, progressive and often fatal disease. A mutation in patients with this hereditary disease makes a toxic form of transthyretin protein that is deposited in the heart and peripheral nerves. Patisiran silences this gene using short pieces of double-stranded RNA that target and…
FDA new drug approvals in Q2 2018
The second quarter of 2018 saw an uptick in drug approvals as 15 new drugs received a green light from the FDA (TABLE 1), compared with 6 in the first quarter. Among the most notable of the new crop was GW Pharmaceuticals’ cannabidiol (Epidiolex), the first cannabis-derived drug to gain FDA approval. Epidiolex was cleared to treat two very rare types of severe childhood epilepsy, Lennox–Gastaut syndrome and Dravet syndrome, and is forecast to reach blockbuster sales of US$2.35 billion by 2024. However, it is hard to know how much of a threat…