Aimmune Therapeutics Inc. is navigating a host of new challenges as it launches Palforzia, the first peanut allergy immunotherapy to be approved by the US Food and Drug Administration. Most notably, it must get physician practices and individual allergists certified to administer the treatment. Aimmune (NASDAQ: AIMT) president and CEO Jayson Dallas talked to our sister … Continue reading “Palforzia Peanut Allergy Immunotherapy: Aimmune CEO on REMS, Manufacturing”
Author: Brenda Sandburg
Court Rules More Trial Data Must Be Posted On ClinicalTrials.gov
Plaintiff Peter Lurie, former US FDA associate commissioner, expects results of hundreds of clinical trials of approved drugs will become available under ruling against HHS; co-plaintiff sought eteplirsen study data. The results of potentially hundreds of clinical trials of approved drugs and medical devices will have to be published on the ClinicalTrials.gov website in the … Continue reading “Court Rules More Trial Data Must Be Posted On ClinicalTrials.gov”