Grail, the cancer detection start-up backed by tech giants Alphabet and Amazon, is already seeking new funding, mere months after it closed a $900 million round in March. The company had previously raised $100 million in 2016.
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.
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.
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.
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.
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