Intra-Cellular Therapies reported its drug Caplyta met the main and secondary goals in the first of three pivotal studies in major depressive disorder. Success in two of them could support expanding the label of the drug, which is currently approved in schizophrenia and bipolar depression.
The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers.
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.
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.
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.
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.
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.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
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.
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.
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.
Northwestern University biotech spinout Naurex just raised $80 million for its CNS drug that targets major depressive disorder – a real win for the psychiatric med space, which has few significant contenders at present. The money’s meant to further develop GLYX-13, an NMDA receptor modulator that’s on the cusp of entering Phase III trials to treat major […]
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