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KQED/KFF Health News —A much-awaited treatment for postpartum depression, zuranolone, hit the market in December, promising an accessible and fast-acting medication for a debilitating illness. Miriam McDonald, who developed severe postpartum depression and suicidal ideation after giving birth in late 2019, battled Kaiser Permanente for more than a year to find effective treatment. Her doctors refused to prescribe brexanolone, the only FDA-approved medication specifically for postpartum depression at the time. Insurers’ policies for zuranolone will be written at a time when the regulatory environment around mental health treatment is shifting. In the meantime, Burkhard said, patients suffering from postpartum depression should not hold back from asking their doctors about zuranolone.

Persons: “, Meiram Bendat, ”, Joy Burkhard, KP’s, Kaiser, Miriam McDonald, ” McDonald, KP, Nico, Keith McDonald, brexanolone, “ Kaiser Permanente, ” “ Kaiser, Burkhard, “ It’s, Dr, Sanjay Gupta, ” Burkhard Organizations: KQED, KFF, brexanolone, FDA, zuranolone, OB, Center, Maternal Mental, Kaiser Permanente, NPR, Department of Labor, Maternal Mental Health, Medicaid, Cal, U.S . Department of Labor, CNN, CNN Health, KFF Health Locations: ”, “ Kaiser, California

☆ The first pill for postpartum depression gives a psychiatrist hope before she gives birth. But is it enough?
▼ + stars: | 2023-09-23 | by ( Dr. Neha Chaudhary | ) edition.cnn.com time to read: +5 min

With the recent approval of the first pill for postpartum depression, I feel conflicted, both professionally and personally. Unfortunately, up to 50% of women with postpartum depression go undiagnosed. A first-of-its-kind medication hits the marketRecently, the US Food and Drug Administration approved the first pill for severe postpartum depression, Zurzuvae (zuranolone). It may even empower clinicians to screen more often for postpartum depression, knowing there’s a potential tool to help people if they do screen positive. The worst part is that mothers living in poverty generally show higher rates of postpartum depression than those from higher-income communities.

Persons: Neha Chaudhary, it’s, there’s, I’m Organizations: Massachusetts General Hospital, Harvard Medical School, Modern Health, CNN, US Food and Drug Administration Locations: Massachusetts

☆ Sage Therapeutics stock plunges more than 50% after FDA denies wider use of postpartum depression drug
▼ + stars: | 2023-08-07 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

In this photo illustration, the Sage Therapeutics logo of a biopharmaceutical company seen on a smartphone and on a pc screen. Shares of Sage Therapeutics fell more than 50% on Monday after the Food and Drug Administration approved the biotech company's oral drug zuranolone for postpartum depression, but not for major depressive disorder, a bigger potential market. The two companies also applied for approval of zuranolone for major depressive disorder, also known as clinical depression. Zuranolone had the potential for $1 billion in peak sales, compared with $250 million to $500 million for postpartum depression, Jefferies analyst Michael Yee said in a research note Sunday. He said clinical depression "was really the big upside driver here" for the companies, while postpartum depression is "much smaller and may not be hugely profitable."

Persons: Sage, Zuranolone, Jefferies, Michael Yee Organizations: Sage Therapeutics, Food and Drug Administration

☆ Oppenheimer says investors are missing opportunities in three biotech areas and the related stocks
▼ + stars: | 2023-05-16 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +4 min

As biopharma investors follow the latest buzz around advancements in clinical research, they may be under-appreciating opportunities in neurology, psychiatry and genetic medicine, according to a report from Oppenheimer. "Valuation multiples across disease areas show CNS [ or central nervous system] and Genetic Medicine at relative low points." In July, the Food and Drug Administration could grant full approval to Leqembi , its Alzheimer's Disease treatment. As a very new area of medicine, gene therapy has greatest potential to accelerate sales growth as treatments come to market. He described immunology multiples as "generally stable" and genetic medicine multiples as highly volatile.

☆ Biogen CEO bets on Alzheimer's drug, pipeline to return to growth
▼ + stars: | 2023-02-15 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

Feb 15 (Reuters) - Biogen Inc (BIIB.O) Chief Executive Officer Christopher Viehbacher said on Wednesday he is banking on high-profile launches of Alzheimer's disease treatment Leqembi and depression drug zuranolone, as well as deals, to help the company return to revenue growth. A controversial approval and problematic launch of previous Alzheimer's disease drug Aduhelm, which like Leqembi was developed with Eisai Co Ltd (4523.T), have further dented investor sentiment. Biogen is also hoping to gain U.S. approval of depression treatment zuranolone this year. Biogen forecast full-year adjusted profit of $15 to $16 per share, compared with analysts' estimates of $15.72 per share. The company reported a fourth-quarter adjusted profit of $4.05 per share, beating estimates compiled by Refinitiv IBES by 57 cents.

☆ The top doctor at a $2.7 billion pharma company developing a new depression drug says we may be 'on the cusp' of a new wave of mental-health treatments
▼ + stars: | 2023-02-13 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +6 min

Most depression treatments don't work quickly and are meant to be taken for long periods of time. Sage Therapeutics is developing a fast-acting drug that patients take for two weeks. That's according to Laura Gault, the chief medical officer at Sage Therapeutics, a Massachusetts-based company working to develop a new antidepressant drug, called zuranolone. Sage's stock has climbed 7.9% in the past 12 months, giving the company a market value of about $2.7 billion. Unlike most other antidepressants, zuranolone is designed to be taken for a short period of timeIn trials, zuranolone has improved symptoms of major depressive disorder and postpartum depression.

☆ Depression treatments haven't changed much in decades. Here are the promising new drugs that could be more precise, work faster, and help more people.
▼ + stars: | 2023-02-02 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +6 min

Advances in depression treatment have been rare over the past few decades. But treatments for mental-health illnesses, like depression, haven't changed much over the past few decades. Insider put together a roundup of the most promising depression treatments today, both those that have won approval and those that are in the later stages of the research process. Unlike most depression treatments on the market, Auvelity is rapid-acting, which means it offers faster relief for patients. MDD is also known as clinical depression and is defined by persistent depressive symptoms.

☆ Biogen's new CEO says Alzheimer's will become a major franchise for the company but that a different drug has the 'biggest undervalued potential'
▼ + stars: | 2023-01-09 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +4 min

But new CEO Christopher Viehbacher said that he sees Alzheimer's becoming a new franchise. He added that zuranolone, an antidepressant, is the "biggest undervalued potential" of the company. On the heels of the approval of a new Alzheimer's drug, Cambridge-based biotech company Biogen seems focused on expanding its focus to a wider range of illnesses. New Alzheimer's drug lecanemab could signal a new franchiseThe first is lecanemab, a drug for Alzheimer's disease that was granted an accelerated approval by the US Food and Drug Administration last week. "I think zuranolone is the biggest undervalued potential of Biogen," Viehbacher said.

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