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BioWorld - Tuesday, April 14, 2026
Home » Topics » Clinical

Clinical
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11-8-Abbott-Amplatzer-Amulet.png

No magic with Abbott’s Amulet compared to Watchman

Nov. 19, 2024
By Annette Boyle
Three years after the U.S. FDA approval of Abbott Laboratories’ Amplatzer Amulet, results of its investigational device exemption trial failed to notably differentiate Abbott’s left atrial appendage occluder system from Boston Scientific Corp.’s market-dominant Watchman device beyond the ability to forego anticoagulants quickly after implantation.
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Neurogene slides on Rett syndrome gene therapy safety concern

Nov. 18, 2024
By Karen Carey
Neurogene Inc.’s stock sank 43% on news that its phase I/II gene therapy, NGN-401, resulted in a serious adverse event in a pediatric Rett syndrome patient receiving the highest dose.
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Illustration of liver infection

The Liver Meeting: A cure for hepatitis B’s low-hanging fruit

Nov. 18, 2024
By Brian Orelli
Patients infected with hepatitis C have had the ability to rid their livers of the virus for some time, while patients with chronic hepatitis B virus infection have been required to take medications for the rest of their lives in the hopes of just dampening damage to the liver caused by the virus. But, at The Liver Meeting 2024, Arbutus presented data from the phase IIa Im-prove study suggesting a cure might be on its way with its DNAi drug, which binds to the viral mRNA promoting its cutting, leading to loss of translation of the viral proteins.
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Boston Scientific Corp.’s Watchman Flx device

Boston Sci study shows Watchman Flx better OPTION than DOAC

Nov. 18, 2024
By Annette Boyle
Boston Scientific Corp.’s OPTION study demonstrated left atrial appendage closure with the Watchman Flx device reduced risk of stroke compared to management with direct oral anticoagulants or warfarin in patients with atrial fibrillation following cardiac ablation. Results were presented at the American Heart Association's Scientific Sessions 2024 and simultaneously published in The New England Journal of Medicine.
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Silhouettes of women
Healing the health divide

Women's health by the data

Nov. 14, 2024
While women’s health has slid under the research radar for decades, large biopharma companies and venture capital firms are beginning to take notice of the untapped market potential. More companies are wandering into the space and exploring avenues of science that were largely ignored for years. A BioWorld analysis of biopharma companies working on women’s health solutions found that while many efforts to improve the well-being of women exist, the proportion of funding and partnering for this emerging sector of medicine still represents only a small slice of the industry’s overall activity.
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Cancer cells under magnifying glass

Another TCR T-cell win as Adaptimmune focuses on rare sarcomas

Nov. 13, 2024
By Jennifer Boggs
On the heels of U.S. FDA approval of its first T-cell therapy, Adaptimmune Therapeutics plc reported positive results from a pivotal study for its second candidate, letetresgene autoleucel, expected to support a rolling BLA submission in 2025 that could bolster the firm’s offerings as it narrows its focus on the rare sarcoma space.
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Amgen stock holds steady as company dismisses analyst report

Nov. 13, 2024
By Lee Landenberger
Amgen Inc. has shrugged off a Cantor Fitzgerald analyst report that wiped about $12 billion from the company’s market cap. The Nov. 12 analyst report noted supplemental data from the company’s phase I study of obesity drug Maritide showing bone mineral density loss in patients.
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AI-generated image of blood cells in a bone marrow biopsy

No RARA, Syros trouble: MDS phase III sinks tamibarotene

Nov. 13, 2024
By Randy Osborne
Syros Pharmaceuticals Inc.’s phase III failure with oral retinoic acid receptor alpha agonist tamibarotene in myelodysplastic syndrome (MDS) meant not only severe stock damage but also defaulting on the loan facility with Oxford Finance LLC, which means an obligation may be accelerated for the company of about $43.6 million, including principal, interest, and other amounts, according to an SEC filing.
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Menin suits? Syndax’s revumenib phase II win in AML measured

Nov. 12, 2024
By Randy Osborne
The competitive menin-inhibitor space chalked further data from Syndax Pharmaceuticals Inc., which disclosed positive top-line results from the pivotal phase II portion of the Augment-101 study, designed to test oral small-molecule revumenib for safety and efficacy. But shares of the firm (NASDAQ:SNDX) closed Nov. 12 at $16.21, down $5.57, or 26%, after the Augment-101 numbers were disclosed.
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Liver illustration

GLP-1s push into MASH as semaglutide 2.4 mg hits endpoints

Nov. 12, 2024
By Marian (YoonJee) Chu
Positive findings from a phase III trial of semaglutide in metabolic dysfunction-associated steatohepatitis (MASH) is moving Novo Nordisk A/S to expand the glucagon-like peptide-1 (GLP-1) agonist’s indications in the U.S. and Europe, the Danish pharma said, as the MASH field sights more novel therapies.
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