Rare diseases are a public health priority. FDA has launched several programs and a final guidance to address the unmet need for orphan drugs.
Author: Jim Gallagher
The acquisitions of targeted radiation therapy companies (TRT) Point Biopharma by Eli Lilly and RayzeBio by Bristol Meyer Squibb have sparked investors’ interest in this therapeutic class. A growing number of companies are now developing TRTs, and GlobalData reports that venture capital deals in the field have grown 550% to $408 million in 2023.1 The … Continued
Authors: Govind Menon, Suruchi Bakshi, J. Krishnan It is well-established that misfolded alpha-synuclein (alpha-syn) is a histopathological marker of Parkinson’s disease. Given this, we focus on key pathways centered around alpha-syn to explore the pathogenesis of Parkinson’s disease. These are …
By Hugo Geerts, PhD, Piet van der Graaf, PharmD, PhD Over the past 20 years, less than a handful of completed Phase III Alzheimer disease (AD) clinical trials have been successful. Despite large investments of capital and research, more than 200 investigational programs have failed or …
In a long-awaited development, Italy’s Medicines Agency, AIFA, underwent transformative changes on January 30th, 2024. This has been a recurrent topic of discussion, with talks of merging the Scientific Technical Advisory Committee (CTS) and the Price and Reimbursement Committee (CPR). However, the COVID-19 pandemic delayed these plans, leading to a continuous extension of the current … Continued
Authors: Liming Fang, Emi Akatsu, Phillip Johnston Founded in 2016, Zhejiang Longcharm Biomedicine Technology Co., Ltd. provides one-stop R&D outsourcing services for the Chinese pharmaceutical industry. They can support BA/BE/PK clinical testing and data analysis services that comply with Chinese and American regulatory requirements for both novel and generic drug development programs. In 2023 July, … Continued
This blog defines the global value dossiers and explains how BaseCase can support creating interactive value-creation tools.