AbbVie, a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. , announced that the U.S. Food and Drug Administration (FDA) has granted priority review for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being investigated for the management of endometriosis with associated pain.
From an analysis of more than 2,000 tumors spanning 12 types of human cancer, scientists have identified 27 new genes that could stop the disease in its tracks.
Clinical development has historically been a laborious and expensive process that stretches across all therapeutic areas. It is driven by lengthy patient recruitment timelines, increasingly complex study designs, and high procedural costs. Depending on whose data you believe, getting a new drug to market can now cost upwards of $1 billion and take more than 10 years or research and development effort. Additionally, a complex and dynamic regulatory framework has made sponsors reluctant to introduce new technologies to facilitate the development process.
Even when the flu vaccine doesn't prevent disease, it can ease some of the consequences, researchers said here.
Ddu has gradually made its way through Europe by attending the CPhI Worldwide 2017 in Frankfurt and Medica 2017 in Düsseldorf, Germany. During conversations with manufacturers, ICH was frequently mentioned. Since China was admitted as one of the regulatory members of ICH in June of last year, it was now placed at the forefront of the discussions.
AstraZeneca and Incyte Corporation are pushing forward on the development of immunotherapy combination treatments.
A new study has found that a pioneering device to repair heart valves is safe and effective, and can reduce the invasiveness and side effects of conventional mitral valve surgery.
Thailand may be one of the countries that pose the biggest challenge for companies who would like to register their pharmaceutical products in Southeast Asia since they require more than your standard documents.
Novartis announced results from the Phase III PARADIGMS study, investigating the safety and efficacy of fingolimod vs. interferon beta-1a, in children and adolescents (ages 10 to <18) with relapsing multiple sclerosis (MS).
The U.S. Food and Drug(FDA) Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.
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