WASHINGTON – A consent decree with the FDA and a potential $500 million settlement with the Department of Justice (DOJ) are the price Ranbaxy Laboratories Ltd. is paying to once again have complete access to the U.S. market.
WASHINGTON – An annual development fee may be necessary to get the biosimilar pathway up and running, but it should be considered a stopgap measure that will end once the route is established, industry representatives told the FDA.
WASHINGTON – An FDA advisory committee faced some stark what-ifs this week in developing a treatment for a disease that no longer exists in the natural world.
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.
