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major depressive disorder
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RayzeBio, Neumora Perk Up the IPO Market, Raising $561M for Clinical Trials
RayzeBio’s IPO will support pivotal testing of a targeted radiopharmaceutical for cancer patients who progress after treatment with Novartis’s Lutathera. Neumora will apply its IPO cash toward Phase 3 testing of a depression drug with a novel mechanism of action.
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Sage, Biogen Drug Is Now the First Approved Oral Med for Postpartum Depression
Sage Therapeutics’ Zurzuvae is the biotech’s second FDA approved product for postpartum depression, following the 2019 nod for IV-infused Zulresso. But in a blow to the multi-billion dollar partnership between Sage and Biogen, Zurzuvae did not win an additional approval in major depressive disorder.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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Sage Therapeutics’ stock tanks as Phase III depression study misses primary endpoint
In a call with investment bank analysts, executives said the trial was nevertheless not a failure and said the trial was supportive of a generalized filing in major depressive disorder, particularly when factoring in data on disease severity and noncompliance.
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Johnson & Johnson’s new antidepressant could face structural barriers to uptake
The FDA approved Spravato in March, but a new paper in JAMA examines some of the barriers inherent in the practice and reimbursement of psychiatry that could get in the way of widespread use of the drug.
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Clinical trials of Allergan’s antidepressant rapastinel fail
An analyst said the news could negatively affect shares of a successor to the company that developed rapastinel – which Allergan bought in 2015 – given that its drugs belong to the same class.
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FDA approves J&J’s Spravato as first novel antidepressant in decades
The drug, a reformulation of ketamine, was approved for patients who have failed on other antidepressants. The original form of ketamine, approved as an anesthetic, has long been explored as a treatment for depression.
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FDA expert panel throws shade at Alkermes antidepressant drug ahead of AdCom meeting
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.