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Bouncing back from a previous rejection, ImmunityBio on Monday secured the FDA’s green light for its IL-15 superagonist Anktiva for non-muscle invasive bladder cancer.
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The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.
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The U.S. Supreme Court on Monday indicated that it will not hear Vanda Pharmaceuticals’ petition in its patent case against Teva Pharmaceuticals regarding the former’s sleep-wake disorder drug Hetlioz.
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Press Release: Rilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia
4/23/2024
Positive results from the LUNA 3 phase 3 study demonstrated that rilzabrutinib 400 mg twice daily orally achieved the primary endpoint of durable platelet response in adult patients with persistent or chronic immune thrombocytopenia.
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ImmunityBio Announces FDA Approval of ANKTIVA®, First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
4/23/2024
ImmunityBio, Inc., an immunotherapy company, announced that the U.S. Food and Drug Administration has approved ANKTIVA plus Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
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Brise Pharmaceuticals Raises nearly $20M in Series Pre-A and Pre-A+ Financing
4/23/2024
Brise Pharmaceuticals Co., LTD., a pioneering company specializing in innovative treatments for acute and chronic pain, has recently completed Pre-A and Pre-A+ financing with a total of approximately $20 million.
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Vertex and TreeFrog Therapeutics Announce Licensing Agreement and Collaboration to Optimize Production of Vertex's Cell Therapies for Type 1 Diabetes
4/23/2024
Vertex Pharmaceuticals Incorporated and TreeFrog Therapeutics announced that Vertex has obtained an exclusive license to TreeFrog's proprietary cell manufacturing technology, C-StemTM, to optimize production of Vertex's cell therapies for type 1 diabetes.
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PharmAbcine's U.S. Subsidiary, Wincal Biopharm, to Present Preclinical Data from its Proprietary OPC Platform Targeting Ocular Diseases at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2024
4/23/2024
PharmAbcine, Inc. announced that the Company's U.S. subsidiary, Wincal Biopharm, Inc., will present preclinical findings on its innovative ocular drug delivery platform at the upcoming conference, Association for Research in Vision and Ophthalmology, the world's largest ophthalmology conference which will be held from May 5th to 9th, 2024 in Seattle, WA, United States.
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Vizient conducts first Insight: Cell, Gene, and Specialty Pharmacy Symposium
4/23/2024
Vizient, Inc. hosted its inaugural Insight: Cell, Gene, and Specialty Pharmacy Symposium, bringing together leading healthcare providers, payers and manufacturers of high-cost, ultra-specialty pharmaceuticals along with other stakeholders to discuss the promise and unique challenges of the rapidly expanding market of cell, gene and other advanced therapies.
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Danaher Reports First Quarter 2024 Results
4/23/2024
Danaher Corporation announced results for the quarter ended March 29, 2024. All results in this release reflect only continuing operations unless otherwise noted.
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CN Bio Raises $21 Million USD in First Close of Series B Investment Round
4/23/2024
CN Bio, a leading provider of single- and multi-organ microphysiological systems, announced it has raised a $21 million investment in the first close of its Series B fundraising round.
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SOPHiA GENETICS Announces Syndicate Bio as First Liquid Biopsy Customer in Africa
4/23/2024
SOPHiA GENETICS, a cloud-native software company in the healthcare space and a leader in data-driven medicine, announced that Nigeria-based Syndicate Bio has signed on to implement MSK-ACCESS® powered with SOPHiA DDM™.
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ITM, Helmholtz Munich and University Hospital Münster Announce First Patient Dosed in Phase I Investigator-Initiated Glioblastoma Trial
4/23/2024
The Departments of Neurosurgery and Nuclear Medicine at the University Hospital Münster, Helmholtz Munich, and ITM Isotope Technologies Munich SE, a leading radiopharmaceutical biotech company, announced that the first patient has been dosed in an investigator-initiated trial with ITM’s radiopharmaceutical drug candidate, ITM-31 for the potential use in glioblastoma patients.
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Transferring Biomedical Research to Patients Faster: ForTra gGmbH Announces Positive Funding Track Record
4/23/2024
ForTra gGmbH für Forschungstransfer der Else Kröner-Fresenius-Stiftung, a non-profit arm of Else Kröner-Fresenius Foundation, published the successful track record of its latest funding projects.
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Medivir provides update from supportive Type C meeting with the FDA; preparations for enhanced phase 2b in HCC with fostrox + Lenvima continue
4/23/2024
Medivir AB announced an update from a Type C meeting with the FDA, regarding the company's plans for a global phase 2b study and opening of an IND for fostroxacitabine bralpamide in the US.
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Lisata Therapeutics and Qilu Pharmaceutical Announce First Patient Treated in Qilu’s Phase 2 Trial in China of LSTA1 in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
4/23/2024
Lisata Therapeutics, Inc. announced that the first patient has been treated in Qilu’s Phase 2 trial in China evaluating LSTA1 (also known as “CEND-1”), Lisata’s lead product candidate, in combination with standard-of-care (“SoC”) chemotherapy as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (“mPDAC”).
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Kiniksa Pharmaceuticals Reports First Quarter 2024 Financial Results and Recent Portfolio Execution
4/23/2024
Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today reported first quarter 2024 financial results and recent portfolio execution.
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HanxBio announces the publication of a research paper in Scientific Reports on preclinical evaluation of Narazaciclib for the treatment of acute myeloid leukemia (AML)
4/23/2024
HanxBio announced that it has published a research article titled "Narazaciclib, a novel multikinase inhibitor with potent activity against CSF1R, FLT3 and CDK6, shows strong anti-AML activity in defined preclinical models" in the Nature Portfolio online journal Scientific Reports.
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Quest Diagnostics Reports First Quarter 2024 Financial Results; Raises Guidance for Full Year 2024
4/23/2024
Quest Diagnostics Incorporated, a leading provider of diagnostic information services, announced financial results for the first quarter ended March 31, 2024.
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Tharimmune Announces Option Agreement for Key Technologies for Generating HER2/HER3 Antibody Drug Conjugates (ADCs)
4/23/2024
Tharimmune, Inc. announced today an option agreement for an exclusive license with Washington University in St. Louis for the rights to develop and commercialize technology related to multiple hybridomas and antibodies directed specifically towards human HER2.