FDA
Data from all nine participants in STIMO trial published in Nature Researchers identify specific neurons activated and remodeled by spinal cord stimulation that enable patients to walk Excerpt from the Press Release: EINDHOVEN, the Netherlands & LAUSANNE, Switzerland & BOSTON–(BUSINESS WIRE)–ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement,…
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Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(“Merrimack” or the “Company”)] announced that Ipsen, SA (“Ipsen”) issued a press release today reporting its primary analysis of the results of its Phase III NAPOLI 3 trial of Onivyde® (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) as a treatment…
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Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Corner Therapeutics, a biotechnology company exploiting a new scientific paradigm to boost memory T cell responses to disease, debuts today with presentation of data on its dendritic cell hyperactivation (hDC) platform at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place November 8-12,…
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Data show trend in decreasing Tregs, presenting unique profile among current IL-2 therapeutics Adding Phase 1/2 clinical trial sites in the U.S. following recent IND application clearance Excerpt from the Press Release: LARKSPUR, Calif.–(BUSINESS WIRE)–Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, today presented early…
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Excerpt from the Press Release: SAN DIEGO, Nov. 3, 2022 /PRNewswire/ — Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a leading neuroscience-focused biopharmaceutical company, today reported additional results from the Phase 3 KINECT-HD study investigating valbenazine for the treatment of chorea associated with Huntington Disease (HD). In December 2021, Neurocrine previously reported that once-daily administration of valbenazine was well tolerated…
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Multicenter Clinical Data from Five US sites Published in International Ophthalmology Excerpt from the Press Release: Worldwide, more than one million trabecular microbypass stents have been implanted in combination with cataract surgery. Despite glaucoma medications and prior microbypass stenting, target IOP may no longer be achieved over time. During 3 to 42 months follow-up, the…
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Excerpt from the Press Release: BOSTON, Nov. 03, 2022 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. (Nasdaq: INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced the first self-administration of INZ-701 in the open-label Phase 2 extension portion of the ongoing Phase 1/2 clinical…
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– Two patients exhibited an unconfirmed partial response at their first scan, and two additional patients saw promising tumor regression activity out of ten efficacy evaluable patients, demonstrating monotherapy activity of milademetan in MDM2-amplified patients – – Drug safety profile of milademetan preliminarily consistent with prior Phase 1 trial – – Protocol amendment planned to…
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MT-101 is the First mRNA-Engineered CAR Monocyte Therapy to be Dosed in Humans Excerpt from the Press Release: CAMBRIDGE, Mass., Oct. 27, 2022 /PRNewswire/ — Myeloid Therapeutics, Inc. (“Myeloid”), a clinical-stage mRNA-immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to MT-101 in patients with refractory or relapsed…
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Excerpt from the Press Release: LEXINGTON, Mass., Oct. 20, 2022 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today that it has initiated studies to expand the number of pathogens detected on the FDA-cleared T2Bacteria® Panel to include the detection of Acinetobacter baumannii.…
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