Although briskness in alliances partially offset sluggishness in M&A, October was far less dynamic than September for strategic deal making within the diagnostics sector. Here’s an overview of the key deals that did come down over the 4-week period beginning in late September 2019.
Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, the FDA issued final guidance allowing companies to submit for simultaneous review for the clinical trial.
With 10 days still left to run, October was shaping up to be the busiest month of 2019 for new product launches. Here’s a summary of the key diagnostic products unveiled so far:
Here's a summary of the key product launches announced from late August through the third week of September, 2019:
A new FDA Technical Specifications document (Tech Doc) lists recommendations for sponsors on use of next generation sequencing data to secure approval of new antiviral drugs and related diagnostic tests providing crucial guidance on six key issues.