After the initial screening of drugs, it is often necessary to check more details of the drugs, such as the research and development status of different indications. In Synapse, drug details can be viewed in 2 ways:
1. Click on the hyperlink of the drug on the Target search result page.
For this example, we are using Inclisiran
2. Another option is to click on the "view detail" hyperlink when searching for the drug.
On the details page of "Inclisiran", you can see its therapeutic area, first approval date and indications, approval timeline, and other information
In addition, you can access various other information such as the R&D Status on the left-hand navigation bar.
Approval Data Source
The US FDA maintains two registries for approved products: the Purple Book (for approved licensed biological products) and the Orange Book (approved drug products). Without being able to differentiate between the two data sources, you would need to manually determine this information. Therefore, we have added a Data Source column for FDA approvals to understand which registry the data has been sourced from to better support user workflows.
Drug Export
Exporting is an essential part of the user workflow to perform analysis offline and share with colleagues. Higher limitations have been implemented to allow users to export the top 2000 drug records, with support for range selection. Users are also able to select fields relevant to their workflow, thereby improving the export experience.
Approvals data –PMDA and NMPA
Regulatory approvals are an important data type in drug development and provide actionable intelligence for competitive intelligence teams. Companies must be aware of the external regulatory environment to answer questions such as: what drugs are currently approved for the indication/target of interest? Therefore, PMDA (Japan) and NMPA (China) approval data have been added to the Drug Detail page to support accurate market intelligence retrieval. For PMDA approvals, users can download the Source PDF directly.
You can access Approvals data by clicking on the 'Approval' tab when on the drug detail page. When available, you will see data options for FDA, EMA, NMPA, and PMDA.