Tags : Drug

Chugai Reports NDA Submission of Risdiplam to the MHLW as

Shots: The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3 FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study results: improvement in motor function in people aged 2-25 with […]Read More

Insights+: The US FDA New Drug Approvals in March and

The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 new products so far in 2019. In 2018, the FDA approved 59 novel products including 42 New Chemical Entity and 17 Biologics while breaking its past year’s records of approval. However, there is a […]Read More

Roche Collaborates with Icagen for the Development of Drug Candidates

Shots: Icagen to receive upfront, up to $274M milestones and royalties on sales from Roche and is responsible for all preclinical activities Roche to fund the program and will perform further development and commercialization activities The focus of the collaboration is to develop pre-clinical stage ion channel modulators using Icagen’s drug discovery platform, for targeting […]Read More