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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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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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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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Health Canada authorizes Tecentriq SC (atezolizumab, solution for subcutaneous injection), the first cancer immunotherapy subcutaneous injection, for multiple cancer types
4/23/2024
Health Canada authorizes Tecentriq SC (atezolizumab, solution for subcutaneous injection), the first cancer immunotherapy subcutaneous injection, for multiple cancer types.
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INmune Bio Inc. Announces 24-Month Stability Validation of XPro™ for Phase III Readiness and Commercial Supply Chain Modeling & Development of Novel Immunogenicity Assay
4/23/2024
INmune Bio, Inc. is delighted to announce the successful completion of the extended stability validation for XPro TM continuous storage in solution at 2-8C.
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UNITY Biotechnology Announces Extension of Phase 2b ASPIRE Clinical Study Evaluating UBX1325 in DME
4/23/2024
UNITY Biotechnology, Inc. today announced that the ongoing Phase 2b ASPIRE study of UBX1325 has been extended from 24 to 36 weeks to assess potentially greater durability compared to aflibercept.
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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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Silo Pharma Announces Positive Results for Intranasal PTSD Treatment
4/23/2024
Silo Pharma, Inc. today announced positive data in the final validation report from the recent pharmacokinetic (PK) study of SPC-15, an intranasal prophylactic treatment for anxiety and post-traumatic stress disorder (PTSD).
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Nanostics Receives Funding from the University of Alberta Innovation Fund to Propel Adoption of the ClarityDX Prostate Test
4/23/2024
University of Alberta Innovation Fund invests in Nanostics to support adoption of its ClarityDX Prostate test.
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Congruence Therapeutics Appoints Frank Taffy as Chief Business Officer
4/23/2024
Congruence Therapeutics announced today the appointment of Frank Taffy, JD as Chief Business Officer.
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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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Flare Therapeutics Appoints Douglas Manion, M.D., FRCP (C) as Chief Executive Officer
4/23/2024
Flare Therapeutics Inc. today announced the appointment of Douglas Manion, M.D., FRCP (C), as Chief Executive Officer, effective immediately.
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Endevica Bio drug candidate shows success in weight loss in new study
4/23/2024
Endevica Bio, a company developing first-in-class peptide drug candidates, announced its novel weight-loss treatment was successful in a recent diet-induced obesity (DIO) rat study.
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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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Tentarix Biotherapeutics Announces the Appointment of Andrew D. Kidd, MD, CFA, as CEO
4/23/2024
Tentarix Biotherapeutics today announced the appointment of Andrew Kidd, MD, as chief executive officer.