An FDA advisory committee this week gave a half-hearted vote of approval – 9-8, with two abstentions – for Alexza Pharmaceuticals Inc.’s Adasuve (Staccato loxapine). But the vote was conditioned on limiting the inhaled antipsychotic to one dose per day and imposing a much stiffer REMS than what the company had proposed. While Alexza didn’t feel that much love from the Psychopharmacologic Drugs Advisory Committee (PDAC), it did get enough to bolster its flailing shares and keep hope alive for FDA approval come the Feb. 4 PDUFA date. A day after the lackluster committee performance, Alexza (NASDAQ:ALXA) hit $1, a...

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.

WASHINGTON – Just in time for the debut in Congress, the FDA is putting the final touches on its first biosimilar user fee structure.

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).

WASHINGTON – With the sun setting next year on two major pediatric drug acts, a debate over pediatric exclusivity hovers on the horizon.

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.