FDA rejects Alkermes antidepressant drug ALKS 5461
The company's shares were down more than 4 percent in Monday morning trading after the agency's decision, which itself followed a negative AdCom vote in November.
The company's shares were down more than 4 percent in Monday morning trading after the agency's decision, which itself followed a negative AdCom vote in November.
Briefing documents from the Psychopharmacologic Drugs Advisory Committee earlier this week had cast doubt on the chances of a positive vote.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The Psychopharmacologic Drugs Advisory Committee will meet on Thursday to vote on whether to recommend the FDA approve the drug, ALKS 5461, an opioid for major depressive disorder.