The Psychopharmacologic Drugs Advisory Committee (PDAC) was not playing the tune Alexza Pharmaceuticals Inc. wanted to hear Monday as the committee tried to harmonize safety concerns for Adasuve with its benefits in treating acute agitation in patients with schizophrenia or bipolar disorder.
With the biopharma industry more regulated, more restricted, more competitive and more vilified than ever before, it can't afford to be paralyzed by the FDA's lack of social media guidance.
WASHINGTON – Being the first can be an uphill battle. That's what Alexza Pharmaceuticals Inc. is finding as it forges ahead with getting the first inhaled antipsychotic approved to treat agitation in patients with schizophrenia or bipolar disorder.
The future of personalized medicine rests in the hands of the U.S. Supreme Court as it mulls arguments presented Wednesday in Mayo Collaborative Services v. Prometheus Laboratories Inc.
The ghost of anemia drugs present could haunt Affymax Inc.'s peginesatide injection when it comes up for discussion Wednesday at a meeting of the FDA's Oncologic Drugs Advisory Committee (ODAC).
Determining whether a risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) is doing the job is proving to be quite a challenge in the absence of definitive, comparative patient-outcome data.
WASHINGTON – With the nation's drug shortage crisis depriving patients of critical treatments and threatening the development of new drugs, lawmakers must address the root causes of the problem – government pricing and regulatory policies that have created a "race to the bottom," a House subcommittee was told.
Making risk evaluation and mitigation strategies (REMS), especially those with elements to assure safe use (ETASU), more effective and less burdensome is a tall order. So the FDA is turning to the experts for advice on assessing those REMS.
