| Today’s Big NewsAug 7, 2023 |
| By James Waldron Sage Therapeutics is preparing to reduce its head count and pipeline in response to the FDA’s rejection of a Biogen-partnered drug as a treatment for major depressive disorder. |
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By Conor Hale Viz.ai has received a green light from the FDA for its artificial intelligence-powered software that sifts through electrocardiograms to spot signs of a thickened or enlarged heart muscle. |
By Eric Sagonowsky By inking a third Stelara patent settlement, Johnson & Johnson is getting more clarity around the forthcoming loss of exclusivity for its top product by sales. |
By Angus Liu Singapore set out on a journey to become a biotech hub back in 2000, when local government made biomedical research the “fourth pillar” of the city state’s economy. With the sudden collapse of Tessa Therapeutics, Singapore is still waiting for its big biotech success story. |
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Thursday, August 3, 2023 | 11am ET / 8am PT Join us for this insightful discussion on how to unlock the full potential of liquid biopsy and be an integral part of the future of precision medicine. We’ll take a deep dive into the latest strategies and solutions designed to help overcome current challenges and empower researchers and clinicians with enhanced capabilities. Register now. 
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By Fraiser Kansteiner Friday, the U.S. FDA gave the green light to zuranolone. Now going by the commercial moniker Zurzuvae, the partners’ drug represents the first and only oral treatment for women with PPD, which affects some 500,000 patients in the U.S. each year, according to Biogen and Sage. |
By Angus Liu As Pfizer eyes possible cost cuts, its COVID vaccine partner BioNTech is “carefully watching” its spending, the German company’s finance chief Jens Holstein said Monday. |
By Nick Paul Taylor Nektar Therapeutics has accused Eli Lilly of botching the analysis of data from phase 1b trials in eczema and psoriasis. Lilly, which has reportedly confirmed the errors, handed back rights to rezpeg earlier this year. |
By Andrea Park About a year after the company’s last distribution hold wrapped up, Outset Medical is once again pausing shipments of a component of its Tablo hemodialysis systems. |
By Gabrielle Masson After a bout of bad luck, Vistagen’s social anxiety spray has puffed out a phase 3 win—data that has sent the biotech's stock soaring. |
By Helen Floersh Preventing malaria infection from turning into disease is one thing, but preventing transmission between mosquitoes and humans in the first place is another. Now, scientists have discovered a strain of bacteria that may be able to do just that. |
By Kevin Dunleavy Less than four months after Astellas’ $5.9 billion buyout of Iveric Bio, the FDA has signed off on the main asset acquired in the deal, the geographic atrophy treatment Izervay. |
By Andrea Park ResMed may have clocked its highest-ever annual revenues in its 2023 fiscal year, but those gains seemingly weren’t enough to satisfy investors. |
By Conor Hale While a standard diagnostic work-up can include digital imaging scans, tumor biopsies and pathology reports, clinicians are still unable to find the original source of the malignancy in about 3% to 5% of patients. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we discuss how to support patients during the cancer drug shortage, plus this week's headlines. |
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Wednesday, August 30, 2023 | 1pm ET/ 10am PT Enzymes have long demonstrated their utility as a green alternative to metal-based catalysts, but the evolution time required can be significant. Join this webinar to learn about an extracellular strategy that reduces the evolution cycle and enables biocatalysis to be used much earlier in development. Register now. 
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