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The biotech blames contract research organization Fortrea for incorrectly coding the dosing sequence in a psoriatic arthritis trial, which it contends resulted in some patients being given the wrong treatments.
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Advancements in asthma biologics spell future hope for patients with severe asthma.
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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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Keep up with the regulator’s latest rulings on novel drugs and expanded indications, as the second half of 2023 promises some major milestone FDA approvals.
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Novocure Announces Portfolio Prioritization and Strategic Restructuring Plan Focused on Near-term Growth Drivers and an Accelerated Path to Profitability
11/28/2023
Novocure (NASDAQ: NVCR) today announced a series of actions to strengthen and optimize business operations to support near-term growth drivers and long-term value creation.
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AmacaThera Closes Series A Extension to Advance Clinical Development of Long Acting, Localized, Non-Opioid Therapeutics to Improve Post-Surgery Patient Care
11/28/2023
AmacaThera announced the closing of a CAD$4.0 million financing round.
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INVO Bioscience Regains Compliance with Nasdaq Minimum Stockholders' Equity Requirement
11/28/2023
INVO Bioscience, Inc. today announced the Company received notice from The Nasdaq Capital Market, LLC ("Nasdaq"), dated November 22, 2023, informing INVO that it has regained compliance with the minimum stockholders' equity requirement as set forth under NASDAQ Listing Rule 5550(b)(1) for continued listing on Nasdaq.
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Aro Biotherapeutics Secures $41.5M Series B Financing
11/28/2023
Aro Biotherapeutics today announced it has secured $41.5M in a Series B funding round.
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Kura Oncology to Participate in the JMP Securities Hematology and Oncology Summit
11/28/2023
Kura Oncology, Inc. today announced that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at the JMP Securities Hematology and Oncology Summit at 2:00 p.m. ET / 11:00 a.m. PT on Tuesday, December 5, 2023.
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Sol-Gel Technologies Ltd to Host Virtual KOL Event on Gorlin Syndrome and the Upcoming Phase 3 Trial for SGT-610
11/28/2023
Sol-Gel Technologies, Ltd. (Nasdaq: SLGL) (“Sol-Gel”), a dermatology company leveraging innovative approaches to develop pioneering treatments for patients with severe skin conditions, and with two approved large-category dermatology products, TWYNEO® and EPSOLAY®, today announced it will host a virtual KOL event on Wednesday, December 6, 2023 at 12:00 PM ET.
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Philips improves workflow and efficiency with next generation ultrasound systems EPIQ Elite and Affiniti at #RSNA23
11/27/2023
Royal Philips, a global leader in health technology, placed workflow and efficiency at the heart of the next generation of its flagship ultrasound systems EPIQ Elite and Affiniti at #RSNA23.
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Kraig Biocraft Laboratories Strengthens Spider Silk Production Operations with Sericulture Experts from India
11/27/2023
Kraig Biocraft Laboratories, Inc., the biotechnology company focused on the development and commercialization of spider silk, announced its continued investment into building its world-class team with the addition of leading sericulture consultants from India.
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SpringWorks Therapeutics Announces FDA Approval of OGSIVEO™ (nirogacestat) as the First and Only Treatment for Adults with Desmoid Tumors
11/27/2023
SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has approved OGSIVEO™ (nirogacestat), an oral gamma secretase inhibitor, for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.
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AWAK Technologies Announces FDA Breakthrough Device Designation for their Artificial Intelligence Enabled Kidney Disease Prediction Tool
11/27/2023
AWAK Technologies today announced that its kidney disease progression prediction (KDPP) Artificial Intelligence (AI) model for CKD patient care has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).
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Enveric Biosciences Announces Manuscript Describing the Development of Lead Product Candidate, EB-373, to be Featured on the Cover of the Journal of Medicinal Chemistry
11/27/2023
Enveric Biosciences Announces Manuscript Describing the Development of Lead Product Candidate, EB-373, to be Featured on the Cover of the Journal of Medicinal Chemistry.
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Rakovina Therapeutics Inc. Announces Q3 2023 Financial Results and Provides Corporate Update
11/27/2023
Rakovina Therapeutics Inc. (TSX-V: RKV, the “Company”), a biopharmaceutical company dedicated to improving the lives of cancer patients through development of novel DNA-damage response inhibitor therapeutics, announced financial results for the quarter ended September 30, 2023, and provided a corporate update.
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GE HealthCare Showcases More Than 40 Innovations, Including AI-Enabled Imaging Technology Solutions Designed for Precision Care at RSNA23
11/26/2023
GE HealthCare will highlight more than 40 innovations, including several key artificial intelligence -enabled technologies within the Imaging, Ultrasound, and digital space at the Radiological Society of North America’s 2023 Annual Meeting taking place Nov. 26-30 in Chicago, IL.
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Mesoblast Files for Orphan Drug and Pediatric Rare Disease Designations for Rexlemestrocel-L as Treatment for Severe Congenital Heart Disease
11/26/2023
Mesoblast Limited announced that it has filed for orphan drug designation and rare pediatric disease designation with the United States Food and Drug Administration for its allogeneic cell therapy Revascor® in the treatment of the congenital heart disease hypoplastic left heart syndrome.
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Enveric Biosciences Announces Presentation of Two Posters at Canadian Chemical Engineering Conference (CSChE 2023)
11/24/2023
Enveric Biosciences today announced the presentation of two posters at the Canadian Chemical Engineering Conference (CSChE 2023) which was held October 29th to November 1, 2023.
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EirGenix's Breast Cancer Biosimilar Receives Marketing Authorization by EC
11/23/2023
EirGenix Inc. announced that its trastuzumab biosimilar medicine which their commercial partner Sandoz plans to commercialise had received a marketing authorization from the European Commission.