Lilly and Daiichi Sankyo try to quash prasugrel panel meeting rumours
This article was originally published in Scrip
Executive Summary
Lillyand Daiichi Sankyoare attempting to damp down rumours over the progress of the US NDA for their novel antiplatelet agent prasugrel (Effient). In a joint statement, the companies, which are co-developing the potential blockbuster, say that they have not been notified of any regulatory action for the NDA or of any decision to have an advisory panel to review the drug. Speculation has mounted that the FDAwas contemplating taking the drug to a panel review, following its failure to complete a review of the product by the PDUFA user fee deadline of September 26th.
You may also be interested in...
The Shifting Sands Of Biopharma R&D
A year is a long time in biopharma. Pharmaprojects’ annual pipeline review finds changes in the therapeutic spread of drug candidates and a reordering of the top R&D companies, as Chinese firms made their presence felt all the more over the past 12 months.
Nine Pivotal Studies To Look Out For In 2024
While not expected to be quite so busy as previous years, 2024 will still see many pivotal clinical trial readouts that should create a splash. Here are nine (plus a few extras) that have caught attention for one reason or another, e.g., for being the first readout for a novel drug class, having the potential to take a product in a new lucrative direction, for maybe being able to succeed where a rival has already failed or even for having been a long time coming.
10 Pivotal Studies To Look Out For In 2024
While not expected to be quite so busy as previous years, 2024 will still see many pivotal clinical trial readouts that should create a splash. Here are ten (plus a few extras) that have caught Scrip’s eye for one reason or another, eg, for being the first readout for a novel drug class, having the potential to take a product in a new lucrative direction, for maybe being able to succeed where a rival has already failed or even for having been a long time coming.