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☆ Biogen beats expectations, hikes outlook as Alzheimer's drug Leqembi and other new products gain traction
▼ + stars: | 2024-08-01 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Biogen on Thursday reported second-quarter earnings and revenue that topped estimates and hiked its full-year guidance, as the company's cost cuts showed progress and sales of its breakthrough Alzheimer's drug, Leqembi, and other new products beat expectations. Leqembi, which Biogen shares with Eisai, became the second drug proven to slow the progression of Alzheimer's to win approval in the U.S. last summer. That's above the $31 million analysts had expected, according to estimates compiled by StreetAccount. Tecfidera, for example, booked $252.2 million in revenue in the second quarter, which is relatively flat from the year-earlier period. Analysts had expected the once-blockbuster drug to rake in $233.3 million in revenue for the quarter, according to StreetAccount.

Persons: Biogen, StreetAccount, Leqembi, Drug Administration greenlit Skyclarys, Biogen's Organizations: Eisai, LSEG, Reata Pharmaceuticals, Drug Administration, Sage Therapeutics Locations: U.S, Europe

☆ 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

REUTERS/Andrew Kelly/File PhotoAug 7 (Reuters) - The U.S. drug regulator's approval of Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) first-of-its-kind postpartum depression (PPD) pill is unlikely to allay the drugmakers' growth concerns, analysts said on Monday. Adverse commentary after their PPD drug was approved by the U.S. Food and Drug Administration (FDA) on Friday sent Sage shares tumbling 40%, while Biogen dropped 3% in premarket trading. Zurzuvae's use as a clinical depression treatment represents a more than $1 billion sales opportunity compared with $250 million to $500 million potential for postpartum depression, said Jefferies analyst Michael Yee. "Postpartum depression is not necessarily where a big commercial opportunity is," Biogen CEO Christopher Viehbacher said last month. The U.S. FDA said last week that additional studies might be required to support the drug's approval for major depressive disorder (MDD), or clinical depression.

Persons: Andrew Kelly, Sage, Biogen, Baird, Brian Skorney, Skorney, Zurzuvae, Jefferies, Michael Yee, Christopher Viehbacher, Yee, Mariam Sunny, Bhanvi, Manas Mishra, Vinay Dwivedi Organizations: Food and Drug Administration, FDA, REUTERS, Sage Therapeutics, U.S . Food, Drug Administration, U.S, Thomson Locations: White Oak , Maryland, U.S, Bengaluru

☆ FDA approves oral pill for postpartum depression for first time
▼ + stars: | 2023-08-05 | by ( ) www.reuters.com time to read: +2 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo/File PhotoAug 4 (Reuters) - The U.S. Food and Drug Administration (FDA) on Friday approved Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) oral pill to treat postpartum depression (PPD) in adults. The companies had sought the FDA's approval for the drug, Zurzuvae, to treat major depressive disorder (MDD), or clinical depression, as well as postpartum depression, which affect millions of people. Analysts have anticipated that the stocks of both companies would fall if the drug was approved only for postpartum depression, due to the smaller patient population. Until now, the FDA said, treatment for postpartum depression was available only as an intravenous injection.

Persons: Andrew Kelly, Zurzuvae, Biogen, Sage, Sriparna Roy, Lavanya, Krishna Chandra Eluri, Leslie Adler, William Mallard Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, Sage Therapeutics, U.S . Drug Enforcement Administration, Therapeutics, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru

☆ US FDA approves Biogen-Sage Therapeutics pill for postpartum depression
▼ + stars: | 2023-08-04 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Andrew Kelly/File Photo/File PhotoAug 4 (Reuters) - The U.S. Food and Drug Administration on Friday approved Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) oral pill to treat postpartum depression (PPD) in adults. The companies had sought the FDA's approval for the drug, Zurzuvae, to treat major depressive disorder), or clinical depression, as well as postpartum depression (PPD), which affect millions of people. Analysts were anticipating the stocks of both companies to fall if the drug was approved only for postpartum depression due to the smaller patient population. Until now, the FDA said, treatment for postpartum depression was available only as an IV injection. Postpartum depression (PPD) affects around one in seven women who give birth.

Persons: Andrew Kelly, Sriparna Roy, Lavanya, Krishna Chandra Eluri, Leslie Adler Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, Sage Therapeutics, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru

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